European Journal of Physical and Rehabilitation Medicine
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EDIZIONI MINERVA MEDICA
EFFICACY OF TWO BRIEF COGNITIVE-BEHAVIOURAL
REHABILITATION PROGRAMMES FOR CHRONIC NECK
PAIN: RESULTS OF A RANDOMIZED CONTROLLED PILOT
STUDY.
Marco MONTICONE, Emilia AMBROSINI, Howard VERNON, Barbara ROCCA,
Gabriele FINCO, Calogero FOTI, SIMONA FERRANTE
European Journal of Physical and Rehabilitation Medicine 2018 Jul 06
DOI: 10.23736/S1973-9087.18.05206-1
Article type: Original Article
© 2018 EDIZIONI MINERVA MEDICA
Article first published online: July 06, 2018
Manuscript accepted: July 5, 2018
Manuscript revised: June 7, 2018
Submission Date: January 26, 2018
1
EFFICACY OF TWO BRIEF COGNITIVE-BEHAVIOURAL REHABILITATION
PROGRAMMES FOR CHRONIC NECK PAIN: RESULTS OF A RANDOMIZED
CONTROLLED PILOT STUDY
Marco Monticone *1,2, Emilia Ambrosini 3, Howard Vernon 4, Barbara Rocca 5, Gabriele Finco 1, Calogero
Foti6, Simona Ferrante3
1Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy;
2Neurorehabilitation Unit, Dept. Neuroscience and Rehabilitation, G. Brotzu Hospital, Cagliari, Italy;
3Neuroengineering and Medical Robotics Laboratory, Department of Electronics, Information and
Bioengineering, Politecnico di Milano, Milan, Italy; 4Canadian Memorial Chiropractic College, Toronto,
Ontario, Canada; 5 Physical Medicine and Rehabilitation Unit, Scientific Institute of Lissone, Clinical and
Scientific Institutes Maugeri, Institute of Care and Research, Lissone (Monza Brianza), Italy; 6Physical
Medicine and Rehabilitation Unit, University of Rome “Tor Vergata”, Rome, Italy.
*Corresponding author: Marco Monticone, Department of Medical Sciences and Public Health, University
of Cagliari, Cittadella Universitaria, Strada Statale, 554 - Monserrato, Cagliari, Italy. E-mail:
marco.monticone@unica.it
Acknowledgments
The Authors wish to thank all of the subjects who took part into the study.
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2
ABSTRACT
Background. Current models of pain behaviour suggest that kinesiophobia prevents the reacquisition of
normal function, promotes the development of maladaptive coping strategies, and contributes to the
disability associated with chronic neck pain (NP).
Aim. Comparing two brief cognitive-behavioural programmes aimed at managing kinesiophobia to
understand which one induces better short-term improvements in disability, fear of movement,
catastrophising, adaptive coping strategies, quality of life (QoL), and pain intensity of chronic NP.
Design. Pilot, randomised, controlled trial, 3-months follow-up.
Setting. Outpatients.
Population. Subjects with chronic NP.
Methods. The population was randomized into two groups: Group A (n=15) underwent four sessions of
cognitive-behavioural therapy (CBT) based on the NeckPix© (1-week duration); Group B (n=15) received
four sessions of CBT based on the Tampa Scale of Kinesiophobia (TSK) (1-week duration). Afterwards, both
groups attended 10 sessions of multimodal exercises (5-week duration). Primary measure: Neck Disability
Index (NDI). Secondary measures: NeckPix©, TSK, Pain Catastrophising Scale, Chronic Pain Coping
Inventory, EuroQol-Five Dimensions, and pain intensity Numerical Rating Scale. Statistics: Linear mixed
model analyses for repeated measures for each outcome measure to evaluate changes over time and
between group.
Results. A significant effect of time was found for all outcomes, while no outcomes showed group and/or
interaction effects. No changes were found in terms of NDI at the end of CBT, while a significant
improvement of about 13 points was found for both groups at the end of the motor training (p=0.001).
Similarly, in terms of quality of life there was no change after the CBT program, and a significant change at
the end of the motor training, with a partial loss at follow-up. From CBT sessions to follow-up both groups
showed a progressive reduction in kinesiophobia, with each group achieving a bigger change in the specific
scale used for the CBT programme.
Conclusion. Two brief cognitive-behavioural rehabilitation programmes based on different methodologies
of managing fear-avoidance beliefs induced similar short-term improvements in subjects with chronic NP.
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3
Clinically significant changes in terms of disability were found in both groups only at the end of a 5-week
motor training, regardless of the cognitive-behavioural rehabilitation programme previously administrated.
Clinical Rehabilitation Impact. Treatment of chronic NP requires cognitive modifications closely linked to
physical performances in order to achieve mental adjustments and guarantee cognitive-behavioural as well
as motor lasting changes.
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4
INTRODUCTION
Current models of pain behaviour suggest that kinesiophobia is more important than pain intensity itself,
and that it may contribute to the preservation of motor impairments.1
In this perspective, it is assumed that
kinesiophobia prevents the reacquisition of normal function, promotes the development of maladaptive
coping strategies, and contributes to the disability associated with chronic neck pain (NP).2
Spinal disorders are characterized by a multidimensional nature and this makes programmes combaining
behavioural strategies targeting kinesiophobia with medication, physiotherapy and/or exercise more and
more recommended.3–7
According to the bio-psychosocial and fear-avoidance models,8,9
these treatments
aim at altering maladaptive thoughts, feelings and behaviours, improving the function of the spine, and
enhancing the use of self-management skills; goal setting and increased physical activity are encouraged in
order to help subjects to modify their experience of chronic pain and gradually gain control over it.10,11
Non-surgical interventions, such as reassurance, education, promotion of a timely return to normal
activities, appropriate use of painkillers and supervised exercises12
, have been proposed for the treatment
of NP but there remains uncertainty about efficacy of cognitive-behavioural treatment (CBT) for this
population. A recent systematic review raised doubts concerning the clinical impact of CBT on neck-related
disability, the possibility of modifying crucial psychological risk factors such as kinesiophobia, their clinical
features and the timing of these effects.13
A widely used approach for assessing fear of movement/re-injury and guiding treatments in subjects with
musculoskeletal complaints is the presentation of a wide-ranging and unfocused pool of thoughts and
behaviours.8
A novel approach to assessing kinesiophobia (or fear-avoidance beliefs) in subjects with
chronic neck pain and whiplash associated disorders has been explored in the presentation of images of
daily living, which the subjects might find stressful; this approach allows a more in-depth investigation of
the important situations for each individual patient which they are actually avoiding during their everyday
activities.14
Based on the models above,8,9
the hypothesis underlying this study was that an innovative, one-week
cognitive-behavioural rehabilitation (multimodal exercises) programme mainly aimed at managing fear of
movement through the presentation of images of daily living would induce short-term improvements in
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5
disability (primary outcome), pain intensity, kinesiophobia, catastrophising, adaptive coping strategies, and
QoL (secondary outcomes) in subjects with chronic NP. The aim of this pilot randomized controlled study
was to evaluate the short-term efficacy of such a programme when compared with a cognitive-behavioural
rehabilitation (multimodal exercises) programme based on managing general pain beliefs. A secondary aim
of the study was to evaluate whether the two different cognitive-behavioural rehabilitation programmes
were able to modify the effects of the subsequent multimodal exercises administered to both intervention
groups.
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6
METHODS
Study design
A pilot randomized controlled trial (RCT) with 3 months follow-up involving subjects with chronic non-
specific NP comparing the efficacy of two approaches to cognitive-behavioural training with subsequent
usual and similar exercises. Consecutive recruitment was conducted at the outpatient facility of a Physical
Medicine and Rehabilitation Unit of a Care and Research Hospital from January to June 2015 and was
stopped when the desired sample size of 30 subjects was reached. This research was approved by the
Institutional Review Board of our Hospital (date of approval: 22/12/2014).
Participants
Inclusion criteria: outpatients with diagnosis of non-specific chronic NP (i.e., a documented history of pain
lasting >3 months),15
a good understanding of Italian, and an age of >18 years. Exclusion criteria: acute
(lasting up to 4 weeks) and subacute NP (lasting up to 12 weeks), cognitive impairment and all causes of
specific NP, such as previous spinal surgery, deformity, infection, fracture or malignancy, and systemic or
neuromuscular diseases. Case histories, cervical radiographs and, in doubtful cases, Computed Tomography
or Nuclear Magnetic Resonance were used to confirm inclusion/exclusion criteria; common degenerative
changes such as disc degeneration or spondyloarthrosis were not considered as exclusion criteria.15
Any
subjects who had previously received CBT were also excluded.
Randomisation
Immediately after the subjects gave their consent, the principal investigator randomised them to one of the
treatment programmes using a list of blinded treatment codes previously generated by a biostatistician and
an automatic assignment system in order to conceal the allocation.
Blinding
The Principal Investigator obtaining and assessing the outcome data, and the biostatisticians making the
analyses were blinded to the treatments. For obvious reasons, the physiatrists, psychologists and
physiotherapists could not be blinded.
Treatment: Brief cognitive-behavioural rehabilitation (multimodal exercises) programmes.
The subjects were randomised into two groups, including 15 subjects each.
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7
Both groups underwent individually, in one-week, four 60-minute sessions of cognitive-behavioural therapy
aimed at improving kinesiophobia, followed by ten 60-minute sessions of multimodal exercises (two
sessions per week for a total of 5 weeks of motor training). The CBT was delivered by the psychologists of
the Rehabilitation Unit, equally experienced (>10 years) in the management of chronic pain and separately
responsible for the groups. After explaining the fear-avoidance model, subjects were educated to view pain
as a situation that can be self-managed rather than a serious disease needing vigilant protection.
Afterwards, the motor training was delivered by two physiotherapists of the Rehabilitation Unit, equally
experienced (>10 years) in chronic NP and separately responsible for the groups.
The difference between the two groups was in the type of cognitive-behavioural therapy the subjects
received:
1) In Group A, the cognitive-behavioural therapy was based on the NeckPix© (a multi-image instrument
developed to assess daily activities in the context of pain-related fear).16
First, the NeckPix© scores
measured at baseline were reviewed. Items with highest scores were addressed first, and then the
remaining ones. The psychologist had the subject identify in greater detail what aspects of these activities
they feared and what those specific fears were, especially with reference to their unique lifestyle and
behaviours. The psychologist identified unjustified thoughts, catastrophizing, maladaptive interpretations
and discussed these with the subject. Then, the psychologist applied focused cognitive-behavioural
reconditioning to assist the subject in formulating more positively adaptive thoughts and interpretations
about the performance of all items, starting with the highest scored ones. The psychologist assisted the
subject in transferring their attention away from these activities to more positive and adaptive strategies
for performance of these activities. The psychologist also assisted in increasing the subject’s level of activity
by means of graded exposure to the situations (e.g. hair washing, using the personal computer, lifting a
weight, cleaning the windows, engaging the reverse,…). Cognitive-behavioural reconditioning was based on
developing an awareness of the problems actually pointed out by the NeckPix©, and their unbiased
relationships with cervical pain and disability. This was expected to help subjects in managing the fearful
situations avoided and constituting an effective means of reacting to unjustified thoughts, despite feeling
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8
pain and/or having cervical problems. Based on the information provided, graded exposure to subsequent
neck exercises was also emphasized.
2) In Group B, the cognitive-behavioural therapy was based on the Tampa Scale for Kinesiophobia findings
(a self-reported questionnaire developed to assess pain beliefs and pain-related fear of movement/reinjury
in general but not during specific daily activities). The main topics for discussion were identified on the
basis of the general fear-avoidance beliefs emerging from the scale items delivered at baseline (e.g. “My
body is telling me I have something dangerously wrong”, “My injury has put my body at risk for the rest of
my life”, “Pain always means that I have injured my body”, “No one should have to exercise when he/she is
in pain”,…). A crucial point was to assist the subjects in understanding why their hurts did not necessarily
harm them as their nervous system (hyper-sensitized in chronic conditions)17
uses pain to protect them at
all costs, but not to inform them about real damage. Cognitive-behavioural reconditioning was based on
helping the subjects to develop the ability to reduce general negative appraisals and catastrophising (also
present in chronic conditions), to master fearful situations, and to plan the return to normal life. Based on
the information provided, graded exposure to subsequent neck exercises was also encouraged.
After the first week, both groups received by means of graded exposure the same motor training that
involved multimodal exercises to improve cervical mobility (by learning physiological neck and upper limbs
patterns of movement including passive and active mobilisations), postural control (by learning ideal
postures when supine, sitting and standing), strengthening muscles (by gradual isometric contraction of
sternocleidomastoideus, trapezius, and scalenus muscles), and stretching (on a gradual basis, global and
segmental neck muscles, including sternocleidomastoideus, trapezius, and scalenus muscles) (weeks: 1-2).
Subsequently, the subjects specifically learned stabilizing techniques for the deep muscles of the neck and
scapula mainly involved, progressively increasing the speed and complexity of the movement patterns (by
gradual stabilization of neck deep muscles when sitting, standing, walking, doing home duties, hobbies or
sports) (weeks: 3-4). Finally, the physical training consisted of task-oriented exercises while maintaining
spinal deep muscles activation, and aimed at progressively improving mobility and strength of the cervical
spine as well as postural, proprioception and neuromotor control of the upper quadrant region (e.g.
reading a book, using the personal computer, drinking, moving from the couch to the sitting position,
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9
moving from a sitting to a standing position, lifting a weight at different heights and directions, …) weeks: 4-
5).18
The task-oriented exercises had also the aim of enforcing the CBT concepts previously received.
Ergonomic advice was provided by means of a booklet given to the participants during the first session in
order to facilitate the modification of daily living activities. At the end of treatment, subjects were asked to
continue with the exercises at home.
No other treatments were offered once subjects were included in the study; the subjects were also
disallowed to take major pharmacological agents; mild analgesics and non-steroidal anti-inflammatory
drugs were permitted.
To ensure there was no variability in treatment administration over the course of the study, a fidelity check,
based on a manual including the complete list of exercises to be delivered, was conducted at the end of
each session to verify that all of the planned exercises were actually performed.
Compliance rates were recorded by the physiotherapists and based on the number of sessions attended by
the subjects at the ambulatory facility.
Outcome measures
Primary outcome measure
Neck Disability Index (NDI): This is a self-administered, 10-item questionnaire concerning NP disability: the
first section rates the intensity of pain and the others describe its disabling effects on typical daily activities.
The score for each item ranges from 0 to 5, and the sum of the ten scores is expressed as a percentage of
the maximum score, and thus ranges from 0 (no disability) to 100 (maximum disability). We used the Italian
version which proved to be reliable and valid.19
Secondary outcome measures
NeckPix©: It is a self-administered multi-image instrument developed to assess daily activities in the
context of pain-related fear. It consists of 10 images including relevant daily activities such as sleeping, hair
washing, using a personal computer, lifting a weight, carrying a bag, engaging reverse gear, cleaning
windows, putting garbage can out, sitting up, and recreation. The score for each item ranges from 0 to 5,
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10
and the total score ranges from 0 to 100, with higher scores representing stronger fear-avoidance beliefs.16
It demonstrated good reliability, validity and responsiveness.20
Tampa Scale of Kinesiophobia (TSK): it assesses pain beliefs and pain-related fear of movement/reinjury in
subjects with musculoskeletal complaints, and consists of a self-report questionnaire in which each
question is scored using a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree);
the total score is calculated by adding the scores of the individual items; we used the 13-item Italian version
that ranges from 13 to 52, with 52 indicating the worst health status.21
Studies have demonstrated its
reliability and validity, and it has been found to be associated with measures of pain, disability, and mood
disorders.21
Pain Catastrophising Scale (PCS): This assesses catastrophising in subjects with musculoskeletal complaints,
and consists of a 13-item self-report questionnaire; the subjects are asked to rate the degree to which they
have any of the thoughts described in the questionnaire using a five-point scale, ranging from 0 (never) to 4
(always). The total score is calculated by adding the scores of the individual items, and ranges from 0 to 52
with 52 indicating the worst health status. We used the Italian version which proved to be reliable and
valid.22
Chronic Pain Coping Inventory (CPCI): This 42-item self-report questionnaire asks subjects to rate the
frequency of their use of coping strategies during the previous week. There are eight subscales (Guarding,
Resting, Asking for assistance, Relaxation, Task persistence, Exercise/Stretch, Seeking for social support,
Coping self-statements), and each item is scored from 0 to 7, with higher scores representing greater use of
coping strategies. For each subscale, the answers to the items that are responded to are summed and
divided by the number of items responded to. We used the Italian version which proved to be reliable and
valid.23
EuroQol-Five Dimensions: It is a generic, self-administered questionnaire that measures health-related
quality of life. It consists of five items concerning mobility, self-care, usual activities, pain/discomfort and
anxiety/depression. Each item is rated on a 3-point adjectival scale. The EQ-VAS was used to quantify the
“overall health state”, with the patient indicating her/his current health status on a 0 (worst score) to 100
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11
(best score) VAS.24,25
The EQ-5D summary index scores [ranging from -0.594 (worse than death) to 1 (best
possible health)] were calculated using the unweighted method of Prieto and Sacristan.26
Numerical Rating Scale (NRS): it assesses pain intensity using an 11-pointnumerical rating scale ranging
from 0 (no pain) to10 (the worst imaginable pain). Subjects were asked to evaluate their actual pain.27
Global Perceived Effect (GPE):This is a self-administered measure of treatment satisfaction consisting of a
five-level Likert scale, which has two improvement levels (much better=1, better=2), one no change level
(approximately the same=3) and two worsening levels (a little worse=4, worse=5).28
During the treatment period (T1: pre-CBT; T2: post-CBT; T3: end of treatment), the questionnaires were
administered by secretaries who checked them and returned any uncompleted part to the subjects for
completion. The GPE was administered only post-CBT (T2) and at the end of treatment (T3). At the three-
month follow-up (T4), the subjects returned to the Institute or were contacted by phone by the same
secretaries in order to complete the questionnaires. The secretaries administrating the questionnaires were
blinded to treatment allocation. Using a specific form, the subjects were asked to report any serious and/or
distressing symptoms they experienced during the study that required further treatment.
Statistics
In order to evaluate changes over time and between groups, linear mixed model analyses for repeated
measures (p=0.05) were made of each of the outcome measures, with group and time entered as fixed
effects and the outcome measures as dependent variables. The crossover effect of time and group was
entered as an interaction term. Since significant effects of time were found, separately for the two
treatment groups, post-hoc analyses (using Bonferroni adjusted alpha levels of .0167) were carried out to
evaluate pairwise differences in the changes of the outcome measures.
Because of its ordinal nature, GPE scores at the end of CBT (T2) and of treatment (T3) of the two groups
were compared using the Mann–Whitney U test.
The statistical analyses were performed using the Italian version of the SPSS 22.
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12
RESULTS
Forty-one subjects were screened, and 30 agreed to participate, were randomised, and completed the
study. No crossover problems arose. Figure 1 shows the study flow chart.
Table 1 shows the clinical and demographic details of the participants: subjects were 49.1 (13.4) and 48.1
(12.4) years old in Group A and B respectively, and had a pain duration before being enrolled in the study of
about 13 months.
Table 2 and Table 3 report the changes over time and between groups for all of the outcome measures. A
significant effect of time was found for all outcomes, while no outcomes showed group and/or interaction
effects. Table 4 and 5 summarize the results of the post-hoc analyses performed separately for the two
groups to evaluate pairwise comparison between changes in all the outcome measures.
At the end of CBT (T2), disability remained unchanged. After training, disability improved by about 32% (13
points) in both groups, indicating a significant effect of time (p=0.001 for both groups in Table 4);
improvements were maintained for at least 3 months for Group A (p=0.111 when T3 was compared to T4),
while Group B exhibited a partial, although not significant, loss (p=0.035).
From T1 to T3 both groups showed a progressive reduction in kinesiophobia, which was only partially
maintained at follow-up. In particular, each group achieved a bigger change in the specific scale used for
the CBT programme: indeed, for Group A a significant difference between T2 and T3 was found only in
terms of the NeckPix© (p=0.014) and for Group B, a significant difference between T1 and T2 was found
only in terms of TSK (p=0.008) but the improvement was lost at follow-up. Concerning catastrophising, only
Group B achieved a significant improvement at T2 (p=0.004), but improvements were lost at follow-up
(p=0.006).
In terms of quality of life, the two groups had a similar behaviour: no change after the CBT programme, a
significant change at the end of the motor training and a partial loss at 3-month follow-up.
Pain intensity (NRS) partially but not significantly improved at the end of the CBT program only for Group A
(p=0.025); significant improvements were found for both groups at T3 (p=0.002 and p<0.001 for Groups A
and B, respectively); improvements were maintained for at least 3 months after the end of the
intervention.
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13
Both groups showed significant improvements over time in adaptive coping subscales and significant
reductions in maladaptive coping subscales, which were hardly maintained at follow-up. Post-hoc analyses
showed that both groups achieved significant improvements from T2 to T3 in terms of Exercise/Stretch
subscale (p<0.001).
Both groups had a similar perception about the efficacy of the interventions both at the end of the CBT and
at the end of the physical training. Indeed, the median GPE values (interquartile range) were 2(1) at T2 for
both groups and 2(1) and 2(0) at T3 for Groups A and B, respectively. There was no significant between-
group difference (p=0.096 at T2 and p=0.370 at T3).
All of the subjects returned to their usual activities (including work activities) by the end of treatment and
at follow-up. All of them reduced their medication use at the end of treatment (Groups A: analgesic 2
persons; Group B: analgesic 3 persons), without further increases at follow-up.
High compliance rates were found during the interventions delivered (CBT: 97%; exercises: 95%).
Minor episodes of transitory pain worsening (two in Group A, and three in Group B) and mood alterations
(three in the Group A and two in Group B) were easily managed by means of symptomatic drugs and
psychological interventions.
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14
DISCUSSION
Both interventions induced significant changes over time but between-group differences were not found
for any of the outcomes measures. However, we can suggest addressing fear of movement beliefs and
motor abilities as early as possible, regardless of a cognitive-behavioural rehabilitative intervention mainly
focused on the presentation of images of daily living or another mainly based on managing general pain
beliefs.
Psychological interventions did not induce within-group effects on disability at the end of CBT sessions, as
they probably required more time to induce substantial changes on everyday activities. On the contrary,
clinically tangible time effects were retrieved at the end of treatment29
most likely due to the advantages
derived from multimodal and task-oriented exercises. At the end of the motor training both groups
achieved a difference in the NDI score of about 13 points, which is almost the double of the minimal
important change of 7 points.29
Both interventions caused a progressive reduction in kinesiophobia from T1 to T3, with greater gains in the
scale specifically addressed. Therefore, properly designed programmes might not only be planned since
early stages of treatment in order to induce changes in avoidance beliefs but also to promote positive
attitudes toward exercises and graded recovery of common activities. However, the levels of kinesiophobia
deteriorated over time and this could be attributable to CBT sessions limited in period, and to the absence
of adequate reinforcement phases, as of late outlined by a systematic review on CBT for subjects with
chronic NP.13
Our findings are also in line with previous studies involving short CBT-based multidisciplinary
interventions, suggesting treatment of chronic pain requires cognitive modifications closely integrated to
physical performances in order to achieve effective mental adjustments and guarantee lasting changes.30–32
More recently, a study showed improvements in disability, pain, kinesiophobia, catastrophising, and quality
of life at one year in subjects with chronic NP by the adoption of cognitive-behavioural modifications
delivered simultaneously to multimodal exercises, confirming the need for a comprehensive approach,
rather than a separate one, in order to consolidate functional outcomes over time and to guarantee
adequate returns to previously fear-avoided activities; also, the above approach received peer-group
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15
support as it was group-based, probably conferring further strength when compared to an individual-based
intervention like the one hereby planned.33
As for catastrophising, the CBT-programme based on the TSK showed an improvement at the end of CBT
sessions, probably indicative of a rapid contribution by a more blanket and non-figurative tool rather than
by a more focused instrument like the NeckPix©. However, gains were lost at follow-up, suggesting that
the short CBT training is not able to produce stronger and durable effects.
As for coping, the reduction we obtained from T1 to T3 in kinesiophobia and catastrophising almost
certainly played a role in reducing maladaptive strategies, such as guarding or resting, and improving
adaptive strategies, such as exercise/stretch and coping self-statement over time. However, these slight
ameliorations were vanished after three months as coping constructs were only marginally faced up,
claiming again for interventions more targeted to their management and issued over longer periods.
Interestingly, the main change was in the Exercise/Stretch subscale and induced by the motor training,
suggesting a role of exercises in making subjects aware of the importance of physical performances;
however, the adoption of this adaptive strategy diminished at follow-up in the absence of correct
reinforcements.
The perceived quality of life improved in both groups by the end of the treatment, and these changes were
mainly induced by the motor training; however, they were lost at follow-up, suggesting the need for a
longer multidisciplinary intervention focused on both physical and mental components in order to allow the
training effects to persist beyond its duration.
Pain intensity decreased in both groups by the end of the treatment. Interestingly, it was maintained also at
short term, suggesting a better role of functional exercises than CBT in sustaining modified pain perception.
GPE evaluation demonstrated satisfactory levels of treatment satisfaction in both groups, confirming the
value of bio-psychosocial approaches to chronic NP complaints.13,34
Despite the sample was representative of the general population undergoing rehabilitation for chronic neck
pain in Italy,18
the interventions cannot be delivered in every setting as they require qualified staff
specialised in chronic pain management and a rehabilitation team specialised in CBT.
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16
This study has some limitations: the small sample reduced its internal validity; aspects other than
kinesiophobia were not specifically targeted during the psychological sessions thus preventing a full CBT to
chronic NP; treatment expectations were not considered, and this confounding factor could only be
partially limited by telling the subjects during enrolment that the efficacy of both treatments had not yet
been established, and that both approaches might contribute to improving their disability; physiotherapists
and psychologists could not be blinded to treatment allocation, potentially influencing subjects’
expectations and adding a positive treatment effect with their higher enthusiasm and attention; screenings
aimed at identifying subjects with visual-based learning difficulties were not conducted; the absence of a
control group receiving only motor training prevented to measure the effects of the CBT programmes
delivered; long-term follow-ups were not evaluated.
In conclusion, two brief cognitive-behavioural rehabilitation programmes based on different methodologies
of managing fear-avoidance beliefs induced similar short-term improvements in subjects with chronic NP.
Clinically significant changes in terms of disability were found in both groups only at the end of a 5-week
motor training. The two different cognitive-behavioural rehabilitation programmes previously
administrated did not influence the effects of subsequent motor training due to CBT sessions limited in
period, absence of adequate reinforcement phases and poor integration between treatments delivered.
Future research is suggested in order to investigate, on an individual basis, multidisciplinary interventions
including CBT addressing also catastrophising and coping strategies as well as involving closer
collaborations between physiotherapists and psychologists over longer periods in adequately sized
populations; follow-ups of at least one year are advised.
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17
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part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not
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21
Table 1. Subjects’ baseline characteristics (n=30).
Group A
(n=15)
Group B
(n=15)
Age (years)a
49.1 (13.4) 48.1 (12.4)
Gender (male/female) 4 / 11 9 / 6
Body mass index (kg/m2
)a
25.8 (5.0) 23.8 (3.5)
Pain duration (months)a
13.5 (6.3) 13.0 (5.1)
Irradiation (yes/no) 6 / 9 4 / 11
Occupation
Employed
Self-employed
Pensioner
Housewife
4
3
7
1
5
2
6
2
Education
Primary school
Middle school
High school
University
1
5
5
4
0
5
6
4
Comorbidities (main)
Cardiac diseases
Respiratory diseases
Gastroenteric diseases
Kidney diseases
Endocrine diseases
Anxiety / depression
2
2
2
1
1
4
1
1
1
4
0
1
Type of drug used
Antidepressant/anxiolytic
Analgesic
2
5
2
6
Smokers (yes/no) 3 / 12 4 / 11
Married (yes/no) 11 / 4 12 / 3
a
Mean values (standard deviation)
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22
Table 2. Changes over time within and between groups for disability, kinesophobia, catastrophising, quality of life, and pain intensity(n=30).
Group T1* T2* T3* T4*
Time
effect
Group
effect
Interaction
effect
Primary outcome
Neck Disability Index (0; 100)
A 40.7 (9.9) 40.0 (8.6) 27.0 (5.3) 29.5 (6.1)
<0.001 0.969 0.642
B 40.4 (9.1) 39.6 (8.6) 26.1 (7.6) 30.7 (8.4)
Secondary outcomes
NeckPix© (0; 100)
A 59.6 (12.1) 52.3 (8.1) 47.3 (6.3) 51.5 (8.2)
<0.001 0.143 0.851
B 61.5 (8.0) 56.7 (8.9) 51.9 (9.1) 55.7 (8.3)
Tampa Scale of Kinesophobia (17; 68)
A 27.9 (5.7) 26.2 (4.1) 23.7 (4.1) 26.6 (4.7)
<0.001 0.284 0.097
B 30.1 (6.2) 23.7 (5.1) 19.7 (4.2) 25.5 (4.2)
Pain Catastrophising Scale (0; 52)
A 25.3 (4.5) 22.3 (4.4) 20.1 (5.2) 23.9 (5.8)
<0.001 0.162 0.423
B 23.9 (4.6) 19.5 (4.0) 16.9 (4.7) 24.5 (5.6)
EuroQol-VAS (0; 100)
A 48.0 (18.6) 46.7 (18.8) 67.3 (10.3) 65.3 (8.3)
<0.001 0.386 0.877
B 44.0 (15.5) 43.3 (12.3) 68.7 (15.1) 59.3 (17.1)
EuroQol - Five Dimensions (-0.594; 1)
A 0.300 (0.157) 0.322 (0.141) 0.491 (0.161) 0.343 (0.169)
<0.001 0.460 0.270
B 0.364 (0.208) 0.332 (0.182) 0.533 (0.204) 0.353 (0.212)
Numerical Rating Scale (0; 10)
A 5.5 (1.6) 4.5 (1.6) 2.5 (1.3) 2.7 (1.7)
<0.001 0.925 0.568
B 5.1 (2.5) 4.7 (2.3) 2.3 (1.2) 2.9 (1.9)
* Mean values (standard deviation)
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23
Table 3. Changes over time within and between groups for the Chronic Pain Coping Inventory (n=30).
Group T1* T2 * T3 * T4 * Time effect Group effect Interaction effect
Chronic Pain Coping Inventory
Guarding (0; 7)
A 4.2 (1.1) 3.3 (0.7) 3.7 (1.1) 4.1 (1.0)
<0.001 0.724 0.616
B 4.4 (1.0) 3.4 (0.8) 3.4 (1.0) 3.8 (0.9)
Resting (0; 7)
A 4.2 (1.4) 4.4 (1.0) 3.4 (1.1) 3.5 (0.9)
0.001 0.542 0.690
B 4.3 (1.5) 4.4 (1.2) 3.5 (1.1) 3.9 (1.1)
Asking for assistance (0; 7)
A 2.6 (1.6) 2.2 (1.2) 1.9 (0.7) 2.5 (0.8)
<0.001 0.212 0.892
B 3.1 (1.4) 2.7 (1.1) 2.2 (0.9) 2.8 (0.9)
Relaxation(0; 7)
A 2.3 (1.5) 2.4 (1.4) 3.4 (1.2) 2.8 (1.5)
<0.001 0.850 0.620
B 2.5 (0.9) 2.5 (0.9) 3.6 (0.9) 2.5 (1.1)
Task persistence(0; 7)
A 1.9 (0.9) 2.8 (0.9) 2.1 (0.6) 2.6 (0.8)
0.001 0.816 0.369
B 2.0 (1.2) 2.6 (0.9) 2.4 (0.7) 2.6 (0.7)
Exercise/Stretch(0; 7)
A 0.4 (0.2) 0.5 (0.2) 2.3 (0.9) 1.6 (0.7)
<0.001 0.407 0.854
B 0.4 (0.2) 0.5 (0.2) 2.6 (1.0) 1.7 (0.8)
Seeking for social support(0; 7)
A 1.1 (0.5) 1.2 (0.4) 1.6 (0.9) 1.9 (0.7)
0.016 0.581 0.359
B 1.4 (1.1) 1.3 (0.8) 1.8 (0.9) 1.7 (1.1)
Coping self-statements(0; 7)
A 2.8 (0.6) 3.3 (0.8) 2.5 (0.5) 2.7 (0.6)
0.004 0.513 0.649
B 3.0 (0.6) 3.3 (0.8) 2.8 (0.7) 2.6 (0.6)
* Mean values (standard deviation)
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24
Table 4. Post-hoc analysis (p < 0.017) of changes over time within groups for disability, kinesiophobia, catastrophising, quality of life, and pain intensity(n=30).
Group T2-T1* T3-T2* T4-T3*
p-value
(T1 vs T2)
p-value
(T2 vs T3)
p-value
(T3 vs T4)
Primary outcome
Neck Disability Index (0; 100)
A -0.7 (0.7) -13.0 (2.6) 2.5 (0.9) 1.000 0.001 0.111
B -0.8 (0.7) -13.5 (2.7) 4.6 (1.4) 1.000 0.001 0.035
Secondary outcomes
NeckPix© (0; 100)
A -7.3 (2.3) -5.0 (1.3) 4.2 (1.8) 0.039 0.014 0.223
B -4.7 (2.2) -4.9 (2.1) 3.9 (1.9) 0.317 0.208 0.338
Tampa Scale of Kinesiophobia (13; 52)
A -1.7 (1.0) -2.5 (1.1) 2.9 (1.2) 0.607 0.207 0.195
B -6.4 (1.6) -3.9 (1.4) 5.7 (1.4) 0.008 0.084 0.007
Pain Catastrophising Scale (0; 52)
A -3.1 (1.2) -2.1 (1.1) 3.8 (1.3) 0.156 0.497 0.065
B -4.5 (1.0) -2.6 (1.2) 7.7 (1.8) 0.004 0.249 0.006
EuroQol-VAS (0; 100)
A -1.3 (2.6) 20.7 (4.8) -2.0 (3.2) 1.000 0.005 1.000
B -0.7 (2.8) 25.3 (3.8) -9.3 (2.3) 1.000 <0.001 0.007
EuroQol - Five Dimensions (-0. 594; 1)
A 0.021 (0.038) 0.170 (0.039) -0.148 (0.033) 1.000 0.004 0.003
B -0.032 (0.042) 0.201 (0.050) -0.180 (0.044) 1.000 0.008 0.006
Numerical Rating Scale (0; 10)
A -1.0 (0.3) -2.0 (0.4) 0.3 (0.4) 0.025 0.002 1.000
B -0.5 (0.3) -2.4 (0.3) 0.6 (0.5) 0.784 <0.001 1.000
* Mean change (standard error)
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25
Table 5. Post-hoc analysis (p<0.017) of changes over time within groups for the Chronic Pain Coping Inventory (n=30).
Group T2-T1* T3-T2* T4-T3*
p-value
(T1 vs T2)
p-value
(T2 vs T3)
p-value
(T3 vs T4)
Chronic Pain Coping Inventory
Guarding (0; 7)
A -0.9 (0.3) 0.4 (0.2) 0.4 (0.2) 0.051 0.629 0.578
B -1.0 (0.3) 0.0 (0.2) 0.4 (0.2) 0.020 1.000 0.284
Resting (0; 7)
A 0.2 (0.2) -1.0 (0.3) 0.1 (0.3) 1.000 0.044 1.000
B 0.1 (0.2) -0.9 (0.4) 0.4 (0.2) 1.000 0.164 0.556
Asking for assistance (0; 7)
A -0.4 (0.3) -0.3 (0.2) 0.6 (0.2) 0.872 1.000 0.092
B -0.4 (0.2) -0.6 (0.2) 0.6 (0.3) 0.573 0.096 0.214
Relaxation (0; 7)
A 0.1 (0.0) 1.0 (0.4) -0.6 (0.3) 0.596 0.079 0.173
B 0.0 (0.0) 1.0 (0.3) -1.0 (0.3) 1.000 0.061 0.031
Task persistence (0; 7)
A 0.9 (0.3) -0.7 (0.2) 0.5 (0.3) 0.073 0.028 0.950
B 0.6 (0.3) -0.2 (0.2) 0.3 (0.3) 0.194 1.000 1.000
Exercise/Stretch (0; 7)
A 0.1 (0.0) 1.8 (0.2) -0.7 (0.2) 0.537 <0.001 0.089
B 0.1 (0.1) 2.1 (0.3) -0.9 (0.3) 0.986 <0.001 0.074
Seeking for social support (0; 7)
A 0.1 (0.1) 0.4 (0.2) 0.3 (0.3) 1.000 0.671 1.000
B -0.1 (0.2) 0.5 (0.2) -0.1 (0.2) 1.000 0.092 1.000
Coping self-statements (0; 7)
A 0.5 (0.3) -0.7 (0.2) 0.1 (0.2) 0.851 0.052 1.000
B 0.3 (0.2) -0.5 (0.2) -0.2 (0.2) 1.000 0.143 1.000
* Mean change (standard error)
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10.23736@s1973 9087.18.05206-1

  • 1.
    European Journal ofPhysical and Rehabilitation Medicine EDIZIONI MINERVA MEDICA ARTICLE ONLINE FIRST This provisional PDF corresponds to the article as it appeared upon acceptance. A copyedited and fully formatted version will be made available soon. The final version may contain major or minor changes. Subscription: Information about subscribing to Minerva Medica journals is online at: http://www.minervamedica.it/en/how-to-order-journals.php Reprints and permissions: For information about reprints and permissions send an email to: [email protected] - [email protected] - [email protected] EDIZIONI MINERVA MEDICA EFFICACY OF TWO BRIEF COGNITIVE-BEHAVIOURAL REHABILITATION PROGRAMMES FOR CHRONIC NECK PAIN: RESULTS OF A RANDOMIZED CONTROLLED PILOT STUDY. Marco MONTICONE, Emilia AMBROSINI, Howard VERNON, Barbara ROCCA, Gabriele FINCO, Calogero FOTI, SIMONA FERRANTE European Journal of Physical and Rehabilitation Medicine 2018 Jul 06 DOI: 10.23736/S1973-9087.18.05206-1 Article type: Original Article © 2018 EDIZIONI MINERVA MEDICA Article first published online: July 06, 2018 Manuscript accepted: July 5, 2018 Manuscript revised: June 7, 2018 Submission Date: January 26, 2018
  • 2.
    1 EFFICACY OF TWOBRIEF COGNITIVE-BEHAVIOURAL REHABILITATION PROGRAMMES FOR CHRONIC NECK PAIN: RESULTS OF A RANDOMIZED CONTROLLED PILOT STUDY Marco Monticone *1,2, Emilia Ambrosini 3, Howard Vernon 4, Barbara Rocca 5, Gabriele Finco 1, Calogero Foti6, Simona Ferrante3 1Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; 2Neurorehabilitation Unit, Dept. Neuroscience and Rehabilitation, G. Brotzu Hospital, Cagliari, Italy; 3Neuroengineering and Medical Robotics Laboratory, Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy; 4Canadian Memorial Chiropractic College, Toronto, Ontario, Canada; 5 Physical Medicine and Rehabilitation Unit, Scientific Institute of Lissone, Clinical and Scientific Institutes Maugeri, Institute of Care and Research, Lissone (Monza Brianza), Italy; 6Physical Medicine and Rehabilitation Unit, University of Rome “Tor Vergata”, Rome, Italy. *Corresponding author: Marco Monticone, Department of Medical Sciences and Public Health, University of Cagliari, Cittadella Universitaria, Strada Statale, 554 - Monserrato, Cagliari, Italy. E-mail: [email protected] Acknowledgments The Authors wish to thank all of the subjects who took part into the study. COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 3.
    2 ABSTRACT Background. Current modelsof pain behaviour suggest that kinesiophobia prevents the reacquisition of normal function, promotes the development of maladaptive coping strategies, and contributes to the disability associated with chronic neck pain (NP). Aim. Comparing two brief cognitive-behavioural programmes aimed at managing kinesiophobia to understand which one induces better short-term improvements in disability, fear of movement, catastrophising, adaptive coping strategies, quality of life (QoL), and pain intensity of chronic NP. Design. Pilot, randomised, controlled trial, 3-months follow-up. Setting. Outpatients. Population. Subjects with chronic NP. Methods. The population was randomized into two groups: Group A (n=15) underwent four sessions of cognitive-behavioural therapy (CBT) based on the NeckPix© (1-week duration); Group B (n=15) received four sessions of CBT based on the Tampa Scale of Kinesiophobia (TSK) (1-week duration). Afterwards, both groups attended 10 sessions of multimodal exercises (5-week duration). Primary measure: Neck Disability Index (NDI). Secondary measures: NeckPix©, TSK, Pain Catastrophising Scale, Chronic Pain Coping Inventory, EuroQol-Five Dimensions, and pain intensity Numerical Rating Scale. Statistics: Linear mixed model analyses for repeated measures for each outcome measure to evaluate changes over time and between group. Results. A significant effect of time was found for all outcomes, while no outcomes showed group and/or interaction effects. No changes were found in terms of NDI at the end of CBT, while a significant improvement of about 13 points was found for both groups at the end of the motor training (p=0.001). Similarly, in terms of quality of life there was no change after the CBT program, and a significant change at the end of the motor training, with a partial loss at follow-up. From CBT sessions to follow-up both groups showed a progressive reduction in kinesiophobia, with each group achieving a bigger change in the specific scale used for the CBT programme. Conclusion. Two brief cognitive-behavioural rehabilitation programmes based on different methodologies of managing fear-avoidance beliefs induced similar short-term improvements in subjects with chronic NP. COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 4.
    3 Clinically significant changesin terms of disability were found in both groups only at the end of a 5-week motor training, regardless of the cognitive-behavioural rehabilitation programme previously administrated. Clinical Rehabilitation Impact. Treatment of chronic NP requires cognitive modifications closely linked to physical performances in order to achieve mental adjustments and guarantee cognitive-behavioural as well as motor lasting changes. COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 5.
    4 INTRODUCTION Current models ofpain behaviour suggest that kinesiophobia is more important than pain intensity itself, and that it may contribute to the preservation of motor impairments.1 In this perspective, it is assumed that kinesiophobia prevents the reacquisition of normal function, promotes the development of maladaptive coping strategies, and contributes to the disability associated with chronic neck pain (NP).2 Spinal disorders are characterized by a multidimensional nature and this makes programmes combaining behavioural strategies targeting kinesiophobia with medication, physiotherapy and/or exercise more and more recommended.3–7 According to the bio-psychosocial and fear-avoidance models,8,9 these treatments aim at altering maladaptive thoughts, feelings and behaviours, improving the function of the spine, and enhancing the use of self-management skills; goal setting and increased physical activity are encouraged in order to help subjects to modify their experience of chronic pain and gradually gain control over it.10,11 Non-surgical interventions, such as reassurance, education, promotion of a timely return to normal activities, appropriate use of painkillers and supervised exercises12 , have been proposed for the treatment of NP but there remains uncertainty about efficacy of cognitive-behavioural treatment (CBT) for this population. A recent systematic review raised doubts concerning the clinical impact of CBT on neck-related disability, the possibility of modifying crucial psychological risk factors such as kinesiophobia, their clinical features and the timing of these effects.13 A widely used approach for assessing fear of movement/re-injury and guiding treatments in subjects with musculoskeletal complaints is the presentation of a wide-ranging and unfocused pool of thoughts and behaviours.8 A novel approach to assessing kinesiophobia (or fear-avoidance beliefs) in subjects with chronic neck pain and whiplash associated disorders has been explored in the presentation of images of daily living, which the subjects might find stressful; this approach allows a more in-depth investigation of the important situations for each individual patient which they are actually avoiding during their everyday activities.14 Based on the models above,8,9 the hypothesis underlying this study was that an innovative, one-week cognitive-behavioural rehabilitation (multimodal exercises) programme mainly aimed at managing fear of movement through the presentation of images of daily living would induce short-term improvements in COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 6.
    5 disability (primary outcome),pain intensity, kinesiophobia, catastrophising, adaptive coping strategies, and QoL (secondary outcomes) in subjects with chronic NP. The aim of this pilot randomized controlled study was to evaluate the short-term efficacy of such a programme when compared with a cognitive-behavioural rehabilitation (multimodal exercises) programme based on managing general pain beliefs. A secondary aim of the study was to evaluate whether the two different cognitive-behavioural rehabilitation programmes were able to modify the effects of the subsequent multimodal exercises administered to both intervention groups. COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 7.
    6 METHODS Study design A pilotrandomized controlled trial (RCT) with 3 months follow-up involving subjects with chronic non- specific NP comparing the efficacy of two approaches to cognitive-behavioural training with subsequent usual and similar exercises. Consecutive recruitment was conducted at the outpatient facility of a Physical Medicine and Rehabilitation Unit of a Care and Research Hospital from January to June 2015 and was stopped when the desired sample size of 30 subjects was reached. This research was approved by the Institutional Review Board of our Hospital (date of approval: 22/12/2014). Participants Inclusion criteria: outpatients with diagnosis of non-specific chronic NP (i.e., a documented history of pain lasting >3 months),15 a good understanding of Italian, and an age of >18 years. Exclusion criteria: acute (lasting up to 4 weeks) and subacute NP (lasting up to 12 weeks), cognitive impairment and all causes of specific NP, such as previous spinal surgery, deformity, infection, fracture or malignancy, and systemic or neuromuscular diseases. Case histories, cervical radiographs and, in doubtful cases, Computed Tomography or Nuclear Magnetic Resonance were used to confirm inclusion/exclusion criteria; common degenerative changes such as disc degeneration or spondyloarthrosis were not considered as exclusion criteria.15 Any subjects who had previously received CBT were also excluded. Randomisation Immediately after the subjects gave their consent, the principal investigator randomised them to one of the treatment programmes using a list of blinded treatment codes previously generated by a biostatistician and an automatic assignment system in order to conceal the allocation. Blinding The Principal Investigator obtaining and assessing the outcome data, and the biostatisticians making the analyses were blinded to the treatments. For obvious reasons, the physiatrists, psychologists and physiotherapists could not be blinded. Treatment: Brief cognitive-behavioural rehabilitation (multimodal exercises) programmes. The subjects were randomised into two groups, including 15 subjects each. COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 8.
    7 Both groups underwentindividually, in one-week, four 60-minute sessions of cognitive-behavioural therapy aimed at improving kinesiophobia, followed by ten 60-minute sessions of multimodal exercises (two sessions per week for a total of 5 weeks of motor training). The CBT was delivered by the psychologists of the Rehabilitation Unit, equally experienced (>10 years) in the management of chronic pain and separately responsible for the groups. After explaining the fear-avoidance model, subjects were educated to view pain as a situation that can be self-managed rather than a serious disease needing vigilant protection. Afterwards, the motor training was delivered by two physiotherapists of the Rehabilitation Unit, equally experienced (>10 years) in chronic NP and separately responsible for the groups. The difference between the two groups was in the type of cognitive-behavioural therapy the subjects received: 1) In Group A, the cognitive-behavioural therapy was based on the NeckPix© (a multi-image instrument developed to assess daily activities in the context of pain-related fear).16 First, the NeckPix© scores measured at baseline were reviewed. Items with highest scores were addressed first, and then the remaining ones. The psychologist had the subject identify in greater detail what aspects of these activities they feared and what those specific fears were, especially with reference to their unique lifestyle and behaviours. The psychologist identified unjustified thoughts, catastrophizing, maladaptive interpretations and discussed these with the subject. Then, the psychologist applied focused cognitive-behavioural reconditioning to assist the subject in formulating more positively adaptive thoughts and interpretations about the performance of all items, starting with the highest scored ones. The psychologist assisted the subject in transferring their attention away from these activities to more positive and adaptive strategies for performance of these activities. The psychologist also assisted in increasing the subject’s level of activity by means of graded exposure to the situations (e.g. hair washing, using the personal computer, lifting a weight, cleaning the windows, engaging the reverse,…). Cognitive-behavioural reconditioning was based on developing an awareness of the problems actually pointed out by the NeckPix©, and their unbiased relationships with cervical pain and disability. This was expected to help subjects in managing the fearful situations avoided and constituting an effective means of reacting to unjustified thoughts, despite feeling COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 9.
    8 pain and/or havingcervical problems. Based on the information provided, graded exposure to subsequent neck exercises was also emphasized. 2) In Group B, the cognitive-behavioural therapy was based on the Tampa Scale for Kinesiophobia findings (a self-reported questionnaire developed to assess pain beliefs and pain-related fear of movement/reinjury in general but not during specific daily activities). The main topics for discussion were identified on the basis of the general fear-avoidance beliefs emerging from the scale items delivered at baseline (e.g. “My body is telling me I have something dangerously wrong”, “My injury has put my body at risk for the rest of my life”, “Pain always means that I have injured my body”, “No one should have to exercise when he/she is in pain”,…). A crucial point was to assist the subjects in understanding why their hurts did not necessarily harm them as their nervous system (hyper-sensitized in chronic conditions)17 uses pain to protect them at all costs, but not to inform them about real damage. Cognitive-behavioural reconditioning was based on helping the subjects to develop the ability to reduce general negative appraisals and catastrophising (also present in chronic conditions), to master fearful situations, and to plan the return to normal life. Based on the information provided, graded exposure to subsequent neck exercises was also encouraged. After the first week, both groups received by means of graded exposure the same motor training that involved multimodal exercises to improve cervical mobility (by learning physiological neck and upper limbs patterns of movement including passive and active mobilisations), postural control (by learning ideal postures when supine, sitting and standing), strengthening muscles (by gradual isometric contraction of sternocleidomastoideus, trapezius, and scalenus muscles), and stretching (on a gradual basis, global and segmental neck muscles, including sternocleidomastoideus, trapezius, and scalenus muscles) (weeks: 1-2). Subsequently, the subjects specifically learned stabilizing techniques for the deep muscles of the neck and scapula mainly involved, progressively increasing the speed and complexity of the movement patterns (by gradual stabilization of neck deep muscles when sitting, standing, walking, doing home duties, hobbies or sports) (weeks: 3-4). Finally, the physical training consisted of task-oriented exercises while maintaining spinal deep muscles activation, and aimed at progressively improving mobility and strength of the cervical spine as well as postural, proprioception and neuromotor control of the upper quadrant region (e.g. reading a book, using the personal computer, drinking, moving from the couch to the sitting position, COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 10.
    9 moving from asitting to a standing position, lifting a weight at different heights and directions, …) weeks: 4- 5).18 The task-oriented exercises had also the aim of enforcing the CBT concepts previously received. Ergonomic advice was provided by means of a booklet given to the participants during the first session in order to facilitate the modification of daily living activities. At the end of treatment, subjects were asked to continue with the exercises at home. No other treatments were offered once subjects were included in the study; the subjects were also disallowed to take major pharmacological agents; mild analgesics and non-steroidal anti-inflammatory drugs were permitted. To ensure there was no variability in treatment administration over the course of the study, a fidelity check, based on a manual including the complete list of exercises to be delivered, was conducted at the end of each session to verify that all of the planned exercises were actually performed. Compliance rates were recorded by the physiotherapists and based on the number of sessions attended by the subjects at the ambulatory facility. Outcome measures Primary outcome measure Neck Disability Index (NDI): This is a self-administered, 10-item questionnaire concerning NP disability: the first section rates the intensity of pain and the others describe its disabling effects on typical daily activities. The score for each item ranges from 0 to 5, and the sum of the ten scores is expressed as a percentage of the maximum score, and thus ranges from 0 (no disability) to 100 (maximum disability). We used the Italian version which proved to be reliable and valid.19 Secondary outcome measures NeckPix©: It is a self-administered multi-image instrument developed to assess daily activities in the context of pain-related fear. It consists of 10 images including relevant daily activities such as sleeping, hair washing, using a personal computer, lifting a weight, carrying a bag, engaging reverse gear, cleaning windows, putting garbage can out, sitting up, and recreation. The score for each item ranges from 0 to 5, COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 11.
    10 and the totalscore ranges from 0 to 100, with higher scores representing stronger fear-avoidance beliefs.16 It demonstrated good reliability, validity and responsiveness.20 Tampa Scale of Kinesiophobia (TSK): it assesses pain beliefs and pain-related fear of movement/reinjury in subjects with musculoskeletal complaints, and consists of a self-report questionnaire in which each question is scored using a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree); the total score is calculated by adding the scores of the individual items; we used the 13-item Italian version that ranges from 13 to 52, with 52 indicating the worst health status.21 Studies have demonstrated its reliability and validity, and it has been found to be associated with measures of pain, disability, and mood disorders.21 Pain Catastrophising Scale (PCS): This assesses catastrophising in subjects with musculoskeletal complaints, and consists of a 13-item self-report questionnaire; the subjects are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a five-point scale, ranging from 0 (never) to 4 (always). The total score is calculated by adding the scores of the individual items, and ranges from 0 to 52 with 52 indicating the worst health status. We used the Italian version which proved to be reliable and valid.22 Chronic Pain Coping Inventory (CPCI): This 42-item self-report questionnaire asks subjects to rate the frequency of their use of coping strategies during the previous week. There are eight subscales (Guarding, Resting, Asking for assistance, Relaxation, Task persistence, Exercise/Stretch, Seeking for social support, Coping self-statements), and each item is scored from 0 to 7, with higher scores representing greater use of coping strategies. For each subscale, the answers to the items that are responded to are summed and divided by the number of items responded to. We used the Italian version which proved to be reliable and valid.23 EuroQol-Five Dimensions: It is a generic, self-administered questionnaire that measures health-related quality of life. It consists of five items concerning mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item is rated on a 3-point adjectival scale. The EQ-VAS was used to quantify the “overall health state”, with the patient indicating her/his current health status on a 0 (worst score) to 100 COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 12.
    11 (best score) VAS.24,25 TheEQ-5D summary index scores [ranging from -0.594 (worse than death) to 1 (best possible health)] were calculated using the unweighted method of Prieto and Sacristan.26 Numerical Rating Scale (NRS): it assesses pain intensity using an 11-pointnumerical rating scale ranging from 0 (no pain) to10 (the worst imaginable pain). Subjects were asked to evaluate their actual pain.27 Global Perceived Effect (GPE):This is a self-administered measure of treatment satisfaction consisting of a five-level Likert scale, which has two improvement levels (much better=1, better=2), one no change level (approximately the same=3) and two worsening levels (a little worse=4, worse=5).28 During the treatment period (T1: pre-CBT; T2: post-CBT; T3: end of treatment), the questionnaires were administered by secretaries who checked them and returned any uncompleted part to the subjects for completion. The GPE was administered only post-CBT (T2) and at the end of treatment (T3). At the three- month follow-up (T4), the subjects returned to the Institute or were contacted by phone by the same secretaries in order to complete the questionnaires. The secretaries administrating the questionnaires were blinded to treatment allocation. Using a specific form, the subjects were asked to report any serious and/or distressing symptoms they experienced during the study that required further treatment. Statistics In order to evaluate changes over time and between groups, linear mixed model analyses for repeated measures (p=0.05) were made of each of the outcome measures, with group and time entered as fixed effects and the outcome measures as dependent variables. The crossover effect of time and group was entered as an interaction term. Since significant effects of time were found, separately for the two treatment groups, post-hoc analyses (using Bonferroni adjusted alpha levels of .0167) were carried out to evaluate pairwise differences in the changes of the outcome measures. Because of its ordinal nature, GPE scores at the end of CBT (T2) and of treatment (T3) of the two groups were compared using the Mann–Whitney U test. The statistical analyses were performed using the Italian version of the SPSS 22. COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 13.
    12 RESULTS Forty-one subjects werescreened, and 30 agreed to participate, were randomised, and completed the study. No crossover problems arose. Figure 1 shows the study flow chart. Table 1 shows the clinical and demographic details of the participants: subjects were 49.1 (13.4) and 48.1 (12.4) years old in Group A and B respectively, and had a pain duration before being enrolled in the study of about 13 months. Table 2 and Table 3 report the changes over time and between groups for all of the outcome measures. A significant effect of time was found for all outcomes, while no outcomes showed group and/or interaction effects. Table 4 and 5 summarize the results of the post-hoc analyses performed separately for the two groups to evaluate pairwise comparison between changes in all the outcome measures. At the end of CBT (T2), disability remained unchanged. After training, disability improved by about 32% (13 points) in both groups, indicating a significant effect of time (p=0.001 for both groups in Table 4); improvements were maintained for at least 3 months for Group A (p=0.111 when T3 was compared to T4), while Group B exhibited a partial, although not significant, loss (p=0.035). From T1 to T3 both groups showed a progressive reduction in kinesiophobia, which was only partially maintained at follow-up. In particular, each group achieved a bigger change in the specific scale used for the CBT programme: indeed, for Group A a significant difference between T2 and T3 was found only in terms of the NeckPix© (p=0.014) and for Group B, a significant difference between T1 and T2 was found only in terms of TSK (p=0.008) but the improvement was lost at follow-up. Concerning catastrophising, only Group B achieved a significant improvement at T2 (p=0.004), but improvements were lost at follow-up (p=0.006). In terms of quality of life, the two groups had a similar behaviour: no change after the CBT programme, a significant change at the end of the motor training and a partial loss at 3-month follow-up. Pain intensity (NRS) partially but not significantly improved at the end of the CBT program only for Group A (p=0.025); significant improvements were found for both groups at T3 (p=0.002 and p<0.001 for Groups A and B, respectively); improvements were maintained for at least 3 months after the end of the intervention. COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 14.
    13 Both groups showedsignificant improvements over time in adaptive coping subscales and significant reductions in maladaptive coping subscales, which were hardly maintained at follow-up. Post-hoc analyses showed that both groups achieved significant improvements from T2 to T3 in terms of Exercise/Stretch subscale (p<0.001). Both groups had a similar perception about the efficacy of the interventions both at the end of the CBT and at the end of the physical training. Indeed, the median GPE values (interquartile range) were 2(1) at T2 for both groups and 2(1) and 2(0) at T3 for Groups A and B, respectively. There was no significant between- group difference (p=0.096 at T2 and p=0.370 at T3). All of the subjects returned to their usual activities (including work activities) by the end of treatment and at follow-up. All of them reduced their medication use at the end of treatment (Groups A: analgesic 2 persons; Group B: analgesic 3 persons), without further increases at follow-up. High compliance rates were found during the interventions delivered (CBT: 97%; exercises: 95%). Minor episodes of transitory pain worsening (two in Group A, and three in Group B) and mood alterations (three in the Group A and two in Group B) were easily managed by means of symptomatic drugs and psychological interventions. COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 15.
    14 DISCUSSION Both interventions inducedsignificant changes over time but between-group differences were not found for any of the outcomes measures. However, we can suggest addressing fear of movement beliefs and motor abilities as early as possible, regardless of a cognitive-behavioural rehabilitative intervention mainly focused on the presentation of images of daily living or another mainly based on managing general pain beliefs. Psychological interventions did not induce within-group effects on disability at the end of CBT sessions, as they probably required more time to induce substantial changes on everyday activities. On the contrary, clinically tangible time effects were retrieved at the end of treatment29 most likely due to the advantages derived from multimodal and task-oriented exercises. At the end of the motor training both groups achieved a difference in the NDI score of about 13 points, which is almost the double of the minimal important change of 7 points.29 Both interventions caused a progressive reduction in kinesiophobia from T1 to T3, with greater gains in the scale specifically addressed. Therefore, properly designed programmes might not only be planned since early stages of treatment in order to induce changes in avoidance beliefs but also to promote positive attitudes toward exercises and graded recovery of common activities. However, the levels of kinesiophobia deteriorated over time and this could be attributable to CBT sessions limited in period, and to the absence of adequate reinforcement phases, as of late outlined by a systematic review on CBT for subjects with chronic NP.13 Our findings are also in line with previous studies involving short CBT-based multidisciplinary interventions, suggesting treatment of chronic pain requires cognitive modifications closely integrated to physical performances in order to achieve effective mental adjustments and guarantee lasting changes.30–32 More recently, a study showed improvements in disability, pain, kinesiophobia, catastrophising, and quality of life at one year in subjects with chronic NP by the adoption of cognitive-behavioural modifications delivered simultaneously to multimodal exercises, confirming the need for a comprehensive approach, rather than a separate one, in order to consolidate functional outcomes over time and to guarantee adequate returns to previously fear-avoided activities; also, the above approach received peer-group COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 16.
    15 support as itwas group-based, probably conferring further strength when compared to an individual-based intervention like the one hereby planned.33 As for catastrophising, the CBT-programme based on the TSK showed an improvement at the end of CBT sessions, probably indicative of a rapid contribution by a more blanket and non-figurative tool rather than by a more focused instrument like the NeckPix©. However, gains were lost at follow-up, suggesting that the short CBT training is not able to produce stronger and durable effects. As for coping, the reduction we obtained from T1 to T3 in kinesiophobia and catastrophising almost certainly played a role in reducing maladaptive strategies, such as guarding or resting, and improving adaptive strategies, such as exercise/stretch and coping self-statement over time. However, these slight ameliorations were vanished after three months as coping constructs were only marginally faced up, claiming again for interventions more targeted to their management and issued over longer periods. Interestingly, the main change was in the Exercise/Stretch subscale and induced by the motor training, suggesting a role of exercises in making subjects aware of the importance of physical performances; however, the adoption of this adaptive strategy diminished at follow-up in the absence of correct reinforcements. The perceived quality of life improved in both groups by the end of the treatment, and these changes were mainly induced by the motor training; however, they were lost at follow-up, suggesting the need for a longer multidisciplinary intervention focused on both physical and mental components in order to allow the training effects to persist beyond its duration. Pain intensity decreased in both groups by the end of the treatment. Interestingly, it was maintained also at short term, suggesting a better role of functional exercises than CBT in sustaining modified pain perception. GPE evaluation demonstrated satisfactory levels of treatment satisfaction in both groups, confirming the value of bio-psychosocial approaches to chronic NP complaints.13,34 Despite the sample was representative of the general population undergoing rehabilitation for chronic neck pain in Italy,18 the interventions cannot be delivered in every setting as they require qualified staff specialised in chronic pain management and a rehabilitation team specialised in CBT. COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 17.
    16 This study hassome limitations: the small sample reduced its internal validity; aspects other than kinesiophobia were not specifically targeted during the psychological sessions thus preventing a full CBT to chronic NP; treatment expectations were not considered, and this confounding factor could only be partially limited by telling the subjects during enrolment that the efficacy of both treatments had not yet been established, and that both approaches might contribute to improving their disability; physiotherapists and psychologists could not be blinded to treatment allocation, potentially influencing subjects’ expectations and adding a positive treatment effect with their higher enthusiasm and attention; screenings aimed at identifying subjects with visual-based learning difficulties were not conducted; the absence of a control group receiving only motor training prevented to measure the effects of the CBT programmes delivered; long-term follow-ups were not evaluated. In conclusion, two brief cognitive-behavioural rehabilitation programmes based on different methodologies of managing fear-avoidance beliefs induced similar short-term improvements in subjects with chronic NP. Clinically significant changes in terms of disability were found in both groups only at the end of a 5-week motor training. The two different cognitive-behavioural rehabilitation programmes previously administrated did not influence the effects of subsequent motor training due to CBT sessions limited in period, absence of adequate reinforcement phases and poor integration between treatments delivered. Future research is suggested in order to investigate, on an individual basis, multidisciplinary interventions including CBT addressing also catastrophising and coping strategies as well as involving closer collaborations between physiotherapists and psychologists over longer periods in adequately sized populations; follow-ups of at least one year are advised. COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 18.
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    20 doi:10.1016/j.jclinepi.2009.09.009 29. Monticone M,Ambrosini E, Vernon H, Brunati R, Rocca B, Foti C, et al. Responsiveness and minimal important changes for the Neck Disability Index and the Neck Pain Disability Scale in Italian subjects with chronic neck pain. Eur Spine J. 2015;24(12):2821-2827. doi:10.1007/s00586-015-3785-5 30. Johnson RE, Jones GT, Wiles NJ, Chaddock C, Potter RG, Roberts C, et al. Active exercise, education, and cognitive behavioral therapy for persistent disabling low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2007;32(15):1578-1585. doi:10.1097/BRS.0b013e318074f890 31. Kääpä EH, Frantsi K, Sarna S, Malmivaara A. Multidisciplinary group rehabilitation versus individual physiotherapy for chronic nonspecific low back pain: a randomized trial. Spine (Phila Pa 1976). 2006;31(4):371-376. doi:10.1097/01.brs.0000200104.90759.8c 32. Smeets RJEM, Vlaeyen JWS, Hidding A, Kester ADM, van der Heijden GJMG, Knottnerus AJ. Chronic low back pain: Physical training, graded activity with problem solving training, or both? The one-year post-treatment results of a randomized controlled trial. Pain. 2008;134(3):263-276. doi:10.1016/j.pain.2007.04.021 33. Monticone M, Ambrosini E, Rocca B, Cazzaniga D, Liquori V, Pedrocchi A, et al. Group-based multimodal exercises integrated with cognitive-behavioural therapy improve disability, pain and quality of life of subjects with chronic neck pain: A randomized controlled trial with one-year follow- up. Clin Rehabil. 2017;31(6). doi:10.1177/0269215516651979 34. Monticone M, Ambrosini E, Cedraschi C, Rocca B, Fiorentini R, Restelli M, et al. Cognitive-behavioral Treatment for Subacute and Chronic Neck Pain: A Cochrane Review. Spine (Phila Pa 1976). 2015;40(19):1495-1504. doi:10.1097/BRS.0000000000001052 COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 22.
    21 Table 1. Subjects’baseline characteristics (n=30). Group A (n=15) Group B (n=15) Age (years)a 49.1 (13.4) 48.1 (12.4) Gender (male/female) 4 / 11 9 / 6 Body mass index (kg/m2 )a 25.8 (5.0) 23.8 (3.5) Pain duration (months)a 13.5 (6.3) 13.0 (5.1) Irradiation (yes/no) 6 / 9 4 / 11 Occupation Employed Self-employed Pensioner Housewife 4 3 7 1 5 2 6 2 Education Primary school Middle school High school University 1 5 5 4 0 5 6 4 Comorbidities (main) Cardiac diseases Respiratory diseases Gastroenteric diseases Kidney diseases Endocrine diseases Anxiety / depression 2 2 2 1 1 4 1 1 1 4 0 1 Type of drug used Antidepressant/anxiolytic Analgesic 2 5 2 6 Smokers (yes/no) 3 / 12 4 / 11 Married (yes/no) 11 / 4 12 / 3 a Mean values (standard deviation) COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 23.
    22 Table 2. Changesover time within and between groups for disability, kinesophobia, catastrophising, quality of life, and pain intensity(n=30). Group T1* T2* T3* T4* Time effect Group effect Interaction effect Primary outcome Neck Disability Index (0; 100) A 40.7 (9.9) 40.0 (8.6) 27.0 (5.3) 29.5 (6.1) <0.001 0.969 0.642 B 40.4 (9.1) 39.6 (8.6) 26.1 (7.6) 30.7 (8.4) Secondary outcomes NeckPix© (0; 100) A 59.6 (12.1) 52.3 (8.1) 47.3 (6.3) 51.5 (8.2) <0.001 0.143 0.851 B 61.5 (8.0) 56.7 (8.9) 51.9 (9.1) 55.7 (8.3) Tampa Scale of Kinesophobia (17; 68) A 27.9 (5.7) 26.2 (4.1) 23.7 (4.1) 26.6 (4.7) <0.001 0.284 0.097 B 30.1 (6.2) 23.7 (5.1) 19.7 (4.2) 25.5 (4.2) Pain Catastrophising Scale (0; 52) A 25.3 (4.5) 22.3 (4.4) 20.1 (5.2) 23.9 (5.8) <0.001 0.162 0.423 B 23.9 (4.6) 19.5 (4.0) 16.9 (4.7) 24.5 (5.6) EuroQol-VAS (0; 100) A 48.0 (18.6) 46.7 (18.8) 67.3 (10.3) 65.3 (8.3) <0.001 0.386 0.877 B 44.0 (15.5) 43.3 (12.3) 68.7 (15.1) 59.3 (17.1) EuroQol - Five Dimensions (-0.594; 1) A 0.300 (0.157) 0.322 (0.141) 0.491 (0.161) 0.343 (0.169) <0.001 0.460 0.270 B 0.364 (0.208) 0.332 (0.182) 0.533 (0.204) 0.353 (0.212) Numerical Rating Scale (0; 10) A 5.5 (1.6) 4.5 (1.6) 2.5 (1.3) 2.7 (1.7) <0.001 0.925 0.568 B 5.1 (2.5) 4.7 (2.3) 2.3 (1.2) 2.9 (1.9) * Mean values (standard deviation) COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic)of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 24.
    23 Table 3. Changesover time within and between groups for the Chronic Pain Coping Inventory (n=30). Group T1* T2 * T3 * T4 * Time effect Group effect Interaction effect Chronic Pain Coping Inventory Guarding (0; 7) A 4.2 (1.1) 3.3 (0.7) 3.7 (1.1) 4.1 (1.0) <0.001 0.724 0.616 B 4.4 (1.0) 3.4 (0.8) 3.4 (1.0) 3.8 (0.9) Resting (0; 7) A 4.2 (1.4) 4.4 (1.0) 3.4 (1.1) 3.5 (0.9) 0.001 0.542 0.690 B 4.3 (1.5) 4.4 (1.2) 3.5 (1.1) 3.9 (1.1) Asking for assistance (0; 7) A 2.6 (1.6) 2.2 (1.2) 1.9 (0.7) 2.5 (0.8) <0.001 0.212 0.892 B 3.1 (1.4) 2.7 (1.1) 2.2 (0.9) 2.8 (0.9) Relaxation(0; 7) A 2.3 (1.5) 2.4 (1.4) 3.4 (1.2) 2.8 (1.5) <0.001 0.850 0.620 B 2.5 (0.9) 2.5 (0.9) 3.6 (0.9) 2.5 (1.1) Task persistence(0; 7) A 1.9 (0.9) 2.8 (0.9) 2.1 (0.6) 2.6 (0.8) 0.001 0.816 0.369 B 2.0 (1.2) 2.6 (0.9) 2.4 (0.7) 2.6 (0.7) Exercise/Stretch(0; 7) A 0.4 (0.2) 0.5 (0.2) 2.3 (0.9) 1.6 (0.7) <0.001 0.407 0.854 B 0.4 (0.2) 0.5 (0.2) 2.6 (1.0) 1.7 (0.8) Seeking for social support(0; 7) A 1.1 (0.5) 1.2 (0.4) 1.6 (0.9) 1.9 (0.7) 0.016 0.581 0.359 B 1.4 (1.1) 1.3 (0.8) 1.8 (0.9) 1.7 (1.1) Coping self-statements(0; 7) A 2.8 (0.6) 3.3 (0.8) 2.5 (0.5) 2.7 (0.6) 0.004 0.513 0.649 B 3.0 (0.6) 3.3 (0.8) 2.8 (0.7) 2.6 (0.6) * Mean values (standard deviation) COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic)of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 25.
    24 Table 4. Post-hocanalysis (p < 0.017) of changes over time within groups for disability, kinesiophobia, catastrophising, quality of life, and pain intensity(n=30). Group T2-T1* T3-T2* T4-T3* p-value (T1 vs T2) p-value (T2 vs T3) p-value (T3 vs T4) Primary outcome Neck Disability Index (0; 100) A -0.7 (0.7) -13.0 (2.6) 2.5 (0.9) 1.000 0.001 0.111 B -0.8 (0.7) -13.5 (2.7) 4.6 (1.4) 1.000 0.001 0.035 Secondary outcomes NeckPix© (0; 100) A -7.3 (2.3) -5.0 (1.3) 4.2 (1.8) 0.039 0.014 0.223 B -4.7 (2.2) -4.9 (2.1) 3.9 (1.9) 0.317 0.208 0.338 Tampa Scale of Kinesiophobia (13; 52) A -1.7 (1.0) -2.5 (1.1) 2.9 (1.2) 0.607 0.207 0.195 B -6.4 (1.6) -3.9 (1.4) 5.7 (1.4) 0.008 0.084 0.007 Pain Catastrophising Scale (0; 52) A -3.1 (1.2) -2.1 (1.1) 3.8 (1.3) 0.156 0.497 0.065 B -4.5 (1.0) -2.6 (1.2) 7.7 (1.8) 0.004 0.249 0.006 EuroQol-VAS (0; 100) A -1.3 (2.6) 20.7 (4.8) -2.0 (3.2) 1.000 0.005 1.000 B -0.7 (2.8) 25.3 (3.8) -9.3 (2.3) 1.000 <0.001 0.007 EuroQol - Five Dimensions (-0. 594; 1) A 0.021 (0.038) 0.170 (0.039) -0.148 (0.033) 1.000 0.004 0.003 B -0.032 (0.042) 0.201 (0.050) -0.180 (0.044) 1.000 0.008 0.006 Numerical Rating Scale (0; 10) A -1.0 (0.3) -2.0 (0.4) 0.3 (0.4) 0.025 0.002 1.000 B -0.5 (0.3) -2.4 (0.3) 0.6 (0.5) 0.784 <0.001 1.000 * Mean change (standard error) COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic)of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
  • 26.
    25 Table 5. Post-hocanalysis (p<0.017) of changes over time within groups for the Chronic Pain Coping Inventory (n=30). Group T2-T1* T3-T2* T4-T3* p-value (T1 vs T2) p-value (T2 vs T3) p-value (T3 vs T4) Chronic Pain Coping Inventory Guarding (0; 7) A -0.9 (0.3) 0.4 (0.2) 0.4 (0.2) 0.051 0.629 0.578 B -1.0 (0.3) 0.0 (0.2) 0.4 (0.2) 0.020 1.000 0.284 Resting (0; 7) A 0.2 (0.2) -1.0 (0.3) 0.1 (0.3) 1.000 0.044 1.000 B 0.1 (0.2) -0.9 (0.4) 0.4 (0.2) 1.000 0.164 0.556 Asking for assistance (0; 7) A -0.4 (0.3) -0.3 (0.2) 0.6 (0.2) 0.872 1.000 0.092 B -0.4 (0.2) -0.6 (0.2) 0.6 (0.3) 0.573 0.096 0.214 Relaxation (0; 7) A 0.1 (0.0) 1.0 (0.4) -0.6 (0.3) 0.596 0.079 0.173 B 0.0 (0.0) 1.0 (0.3) -1.0 (0.3) 1.000 0.061 0.031 Task persistence (0; 7) A 0.9 (0.3) -0.7 (0.2) 0.5 (0.3) 0.073 0.028 0.950 B 0.6 (0.3) -0.2 (0.2) 0.3 (0.3) 0.194 1.000 1.000 Exercise/Stretch (0; 7) A 0.1 (0.0) 1.8 (0.2) -0.7 (0.2) 0.537 <0.001 0.089 B 0.1 (0.1) 2.1 (0.3) -0.9 (0.3) 0.986 <0.001 0.074 Seeking for social support (0; 7) A 0.1 (0.1) 0.4 (0.2) 0.3 (0.3) 1.000 0.671 1.000 B -0.1 (0.2) 0.5 (0.2) -0.1 (0.2) 1.000 0.092 1.000 Coping self-statements (0; 7) A 0.5 (0.3) -0.7 (0.2) 0.1 (0.2) 0.851 0.052 1.000 B 0.3 (0.2) -0.5 (0.2) -0.2 (0.2) 1.000 0.143 1.000 * Mean change (standard error) COPYRIGHT© EDIZIONI MINERVA MEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic)of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.
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    COPYRIGHT© EDIZIONI MINERVAMEDICA This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame oruse framing techniques to encloseany trademark, logo, or otherproprietary information of the Publisher.