Abstract
Objective: To evaluate the effect of a group-based multidisciplinary rehabilitation programme on
disability, pain and quality of life in subjects with chronic neck pain.
Design: Randomized controlled trial. Setting: Specialized rehabilitation centre.
Subjects: A total of 170 patients (mean age of 53 years (13); 121 females).
Interventions: The multidisciplinary group underwent a multidisciplinary rehabilitation programme
combining multimodal exercises with psychologist-lead cognitive-behavioural therapy sessions. The general exercise group underwent general physiotherapy. Both groups followed group-based programmes once a week for ten weeks. Additionally, the multidisciplinary group met with the psychologist once a week for a 60-minute session.
Main measures: The Neck Disability Index (primary outcome), the Tampa Scale for Kinesiophobia, the Pain
Catastrophizing Scale, a pain numerical rating scale and the Short-Form Health Survey. The participants were evaluated before, after training and after 12 months.
Results: A linear mixed model for repeated measures was used for each outcome measure. Significant effects
(p-value <0.001) were found over time and between groups for all outcome measures. After training, significant improvements were found for both groups for all outcome measures except kinesiophobia and
Corresponding author:
Marco Monticone, Department of Public Health, Clinical and Molecular Medicine, University of Cagliari, Cittadella Universitaria, Strada Statale, 554 Monserrato, Cagliari, Italy. Email: marco.monticone@unica.it
Received: 25 November 2015; accepted: 6 May 2016
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
Marco Monticone
1,2, Emilia Ambrosini
2,3, Barbara Rocca
2, Daniele Cazzaniga
2,
Valentina Liquori
2, Alessandra Pedrocchi
3and Howard Vernon
4 1 Department of Public Health, Clinical and Molecular Medicine, University of Cagliari, Cagliari, Italy2 Physical Medicine and Rehabilitation Unit, Scientific Institute of Lissone, Salvatore Maugeri Foundation IRCCS, Lissone, Italy 3 Neuroengineering and Medical Robotics Laboratory, Politecnico di Milano, Milan, Italy
4 Canadian Memorial Chiropractic College, Toronto, Ontario, Canada
Keywords
Chronic neck pain, rehabilitation, task-oriented exercises, cognitive-behavioural therapy, randomized controlled trial
"This is the Accepted Manuscript version of the following article: Marco Monticone, Emilia Ambrosini, Barbara Rocca [at 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.
catastrophizing, which did not change in the control group; however, the improvements were significantly greater for the multidisciplinary group. At 12-month follow-up a clinically meaningful between-group difference of 12.4 Neck Disability Index points was found for disability.
Conclusions: A group-based multidisciplinary rehabilitation programme including cognitive-behavioural
therapy was superior to group-based general physiotherapy in improving disability, pain and quality of life of subjects with chronic neck pain. The effects lasted for at least one year.
Keywords
Chronic neck pain, rehabilitation, task-oriented exercises, cognitive-behavioural therapy, randomized controlled trial
Received: 25 November 2015; accepted: 6 May 2016
Introduction
Neck pain aetiology is multifactorial and includes age, sex, wrong posture, repetitive strains and poor self-rated health.1 Research based on bio-social models links chronic neck pain to psycho-logical factors. Among these, kinesiophobia has been reported as an important determinant.2,3 It is a topic of debate whether the modification of cogni-tive processes and maladapcogni-tive pain behaviours can actually lead to clinically meaningful changes in disability, pain and quality of life.4
There is also uncertainty about the effective-ness of specific types of exercises in the medium- and long-term, making it difficult to choose between traditional exercises aimed at improving isometric muscle properties and increasing the range of motion or task-oriented exercises aimed at early cervical functional recovery.5 Overall, existing single-factor treatments have been shown to be relatively ineffective. Multidisciplinary bio-psychosocial interventions are increasingly rec-ommended in subjects with chronic neck and low back pain to alter maladaptive thoughts and behaviours, improve disability and enhance the use of self-management skills.6–9
A recent review of cognitive-behavioural treat-ment for chronic neck pain found that it induced significant changes in short-term pain relief when compared with no treatment; however, these effects were not clinically meaningful.10 Among the selected studies, only one was group-based but, owing to methodological shortcomings, its results
were inconclusive.11 However, group-based pro-grammes based upon the bio-psychosocial model were encouraged, particularly to examine the effects derived from peer group support.12,13
Given these premises, we undertook a rand-omized controlled study aimed at evaluating the effectiveness of a multidisciplinary programme incorporating group-based cognitive-behavioural therapy focused on kinesiophobia, as well as group-based task-oriented exercises in comparison with group-based general physiotherapy5 in the treatment of chronic neck pain. The hypothesis was that the multidisciplinary programme would induce clinically significant improvements in disability, pain and quality of life, and that these would be maintained in the long term.
Methods
This randomized, parallel-group superiority-con-trolled trial was conducted in a secondary care rehabilitation hospital and approved by the hospi-tal’s Institutional Review Board (number:8; date of approval: 3 december 2009). The trial was registered in the ISRCTN registry with the ID number ISRCTN14581536.
Participants
The inclusion criteria were a diagnosis of non-spe-cific chronic neck pain (i.e. a documented history
of pain lasting >3 months), a good understanding of Italian and an age of >18 years. The exclusion cri-teria were acute and subacute neck pain, cognitive impairment and all causes of specific neck pain, such as previous spinal surgery, deformity, disc herniation, infection, fracture, myelopathy or malignancy, whiplash injuries, and systemic or neuromuscular diseases, ruled out by means of case histories and imaging. Any subjects who had previously received cognitive-behavioural therapy were also excluded.
Outpatients visiting the hospital between January 2010 and December 2013 were evaluated by two physiatrists coordinated by the principal investigator. Those satisfying the inclusion criteria were asked to declare their willingness to comply with whichever treatment option to which they were randomly assigned. Once the patient gave their consent, the biostatistician randomized the subject to one of the two treatment programmes using a permuted-block randomization procedure. The list of treatment codes was previously gener-ated and stored in Matlab and an automatic assign-ment system, also developed in Matlab, was used to conceal the allocation.
The principal investigator obtaining and assess-ing the data and the biostatistician makassess-ing the anal-yses were blinded to treatment allocation. The physiotherapists, the psychologist and the patients could not be blinded. In order to partially limit expectation bias and to reduce problems of crosso-ver, patients were blinded to the study’s hypothesis by telling them the trial was intended to compare two approaches, whose effectiveness had not been established yet.
Interventional programmes
Interventions were delivered by a psychologist and two equally experienced physiotherapists, separately responsible for the multidisciplinary and the general exercise group. Each participant was evaluated individually by means of postural observation, cervical range of motion examina-tion, manual muscle testing, muscle length assess-ment, deep neck flexors endurance examination, as described by Cleland et al.14 Based on this
evaluation, the exercises were planned and car-ried out in groups of five patients each. Given that the Italian National System allows for 10 rehabili-tative sessions for outpatients and owing to the complex nature of chronic complaints, the physi-otherapists arranged one 60-minute session of physical training per week for ten weeks and asked the patients to repeat the exercises at home. The multidisciplinary group met with the psy-chologist once a week for a 60-minute session as described below. Thus, the multidisciplinary pro-gramme lasted a total of 20 hours, while the gen-eral exercise programme lasted 10 hours.
Multidisciplinary group. Multimodal exercises were first introduced to improve, by means of graded exposure, cervical mobility, postural control, strengthening muscles and stretching the neck.5 Patients learned stabilizing techniques for neck deep muscles, progressively increasing the speed and complexity of the movements.15–17 Subse-quently, task-oriented exercises while maintaining spinal deep muscle activation were introduced.
Under the supervision of the psychologist, sub-jects were also involved in group-based cogni-tive-behavioural therapy aimed at modifying fear of movement and maladaptive illness behaviour. The situations to handle were identified on the basis of the fear-avoidance beliefs emerging from the group discussion of the activities more fre-quently reported, the administered questionnaires and the presentation of images showing neck-stressing activities.18 Whenever fear-avoidance behaviours of a single subject were revealed, these were shared and debated within the whole group to identify better solutions, as correct re-learning and cognitive reconditioning were based on developing an awareness of the problem and relevant managing. Subjects were assisted in transferring their attention from kinesiophobia to increasing their level of activity by means of graded exposure to exercises and the situations they previously identified as dangerous. This approach allowed them to gradually overcome motor difficulties and prevent alarm of an already hyper-sensitized nervous system while re-learn-ing the correct execution of the exercises.19
General exercise group. General physiotherapy included exercises for muscle strengthening, regional stretching and spinal mobilization.5
Both groups. Ergonomic advice was provided by means of a booklet given to the participants during the first session in order to facilitate the modifica-tion of daily living activities. At the end of treat-ment, patients were asked to continue with the exercises at home.
More details on the interventions are reported in Appendix 1, available online.
To ensure that there was no variability in treat-ment administration over the course of the study, a fidelity check, based on a manual including the complete list of exercises to be delivered, was con-ducted at the end of each session to verify that all of the planned exercises were actually performed. Compliance rates were recorded by the physiother-apists and based on the number of sessions attended by the subjects at the ambulatory facility.
No other treatments (e.g. physical modalities, nerve blocks) were offered once patients were included in the study; the patients were also disal-lowed to take major pharmacological agents, such as opioids, steroids, anticonvulsants and antide-pressant analgesics, and in case some patients were on such medication at baseline, they were encour-aged to interrupt their consumption. Mild analge-sics and non-steroidal anti-inflammatory drugs were, however, permitted. Family doctors were asked to avoid referrals for other treatments while the participants were undergoing the programmes. Spouses, significant others or parents were asked to support patients’ compliance and to inform the staff promptly if any difficulty was encountered in order to strengthen treatment adherence and mini-mize drop-outs.
Outcome measures and statistics
Disability (primary outcome) was assessed using the validated Italian version of the self-reported 10-item Neck Disability Index.20 The total score ranged from 0 (no disability) to 100% (full disability). At each administration, subjects were asked to consider their scores with respect to ‘the last seven days’.
Kinesiophobia was assessed using the validated Italian 13-item version of the self-report Tampa Scale for Kinesiophobia,21 with the reversed items removed, ranging between 13 (no fear) to 52 (max-imal fear).
Catastrophizing was evaluated by means of the 13-item validated Italian version of the self-reported Pain Catastrophizing Scale.22 The total score ranged from 0 to 52, with higher scores rep-resenting greater catastrophizing.
Pain intensity was assessed using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (the worst imaginable pain).23 Patients were asked to evaluate their actual pain.
Quality of life was assessed using the Italian version of the self-report Short-Form Health Survey24,25 with its eight domain scores ranging from 0 (the worst perceived quality of life) to 100 (the best perceived quality of life). The question-naires were completed before treatment, ten weeks later (posttraining), and 12 months after the end of treatment (follow-up).
During the treatment period, the questionnaires were administered by secretaries who checked them and returned any uncompleted part to the patients for completion. At follow-up, the patients 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.
At the end of treatment, subjects were also asked to rate the effectiveness of treatment using the 5-point Likert Global Perceived Effect scale: 1 = helped a lot, 2 = helped, 3 = helped only a little, 4 = did not help, 5 = made things worse.26 Using a specific form, patients were asked to report any symptoms they experienced during the study that required further treatment.
The sample size was computed using the Italian Neck Disability Index, for which it was estimated that a between-group difference of 7 points should be considered as clinically important.27 In order to assure 80% statistical power and 5% type I error, and considering a standard deviation of 15.4 points,27 154 patients were required, but 170 were actually recruited to allow for a drop-out rate of 10%.
Intention-to-treat analysis was conducted and linear mixed model analyses for repeated measures were made for each of the outcome measures to evaluate changes over time and between groups. This approach was selected since it has been shown to be a valid method in case of missing data.28,29 Because of its categorical nature, Global Perceived Effect was analysed using the Mann–Whitney U-test. Finally, the number needed to treat with 95% confidence interval (CI) for the proportion of patients achieving a change above the clinically important difference for the primary outcome was
computed. The data were analysed using SPSS 22.0 software.
Results
The study flowchart is reported in Figure 1: 198 patients were screened and 170 were actually recruited, randomized and included in the analysis. No crossover problems arose as no patient asked to switch groups.
At baseline, the two groups showed similar demographic characteristics (Table 1) and outcome
measures (Table 2). The sample was characterized by a moderate level of disability and pain.
The linear mixed model analysis found a sig-nificant effect of time (p < 0.001), group (p < 0.001) and time by group interaction (p < 0.001) for all outcome measures, as reported in Tables 3 and 4.
Significant improvements were found for both groups in terms of disability and pain intensity, but the multidisciplinary group improved significantly
more. After training, the between-group difference for Neck Disability Index scores was 12.4 and a further increase was achieved at follow-up (Table 3). The number needed to treat (95% CI) for the proportion of patients achieving a change above 7 for the primary outcome was 2 (1.5; 2.4).
Concerning kinesiophobia and catastrophizing, no changes were highlighted after training in the control group, while a significant improvement
Table 1. Patients’ baseline characteristics (n = 170).
Multidisciplinary group
(n = 85) General exercise group(n = 85)
Age (years)a 53.8 (13.3) 52.0 (12.1)
Gender (male/female)a 24/61 25/60
Body mass index (kg/m2)a 22.5 (2.5) 22.0 (2.7)
Pain duration (months)a 23.3 (20.7) 25.7 (20.7)
Pain radiation to the arm (yes/no) 40/45 25/60
Previous treatment by GP/PT 60/9 64/10 Sick-leave 7 9 Occupation Employed 28 35 Self-employed 26 22 Pensioner 19 16 Domestic works 12 12 Education Primary school 6 4 Middle school 31 19 High school 36 44 University 12 18 Comorbidities (principal) Cardiac diseases 11 12 Respiratory diseases 4 3 Gastroenteric diseases 7 8 Kidney diseases 1 2 Endocrine diseases 7 5 Other 5 4
Type of drug used
Antidepressant/anxiolytic 2 3 Analgesic 12 15 Muscle relaxant 9 10 NSAIDs/corticosteroid 18 21 Smokers (yes/no) 18/67 20/65 Married (yes/no) 60/25 57/28 Sports (yes/no) 32/53 31/54
aMean values (standard deviation).
was exhibited by the multidisciplinary group (Table 3).
Table 4 reports the results of the Short Form Health Survey subscales: at the end of the interven-tion emointerven-tional role and mental health achieved a between-group difference of >20%, while the other subscales showed a mean difference of about 15%. These differences slightly increased at follow-up for all subscales except the mental health, which preserved the posttraining change at follow-up.
The multidisciplinary group was more satisfied with the intervention: the median (interquartile range) of the Global Perceived Effect score was 1(1) and 3(1) for the multidisciplinary and general exercise group, respectively. The between-group difference was statistically significant (p < 0.001).
At the 12-month follow-up all of the subjects belonging to the multidisciplinary group returned to their work activities, while five subjects in the gen-eral physiotherapy group were still on sick-leave.
Table 2. Patients’ comparison at baseline (n = 170).
Multidisciplinary groupa
(n = 85) General exercise group
a
(n = 85)
Primary outcome
Neck Disability Index (0–100) 41.9 (6.2) 41.1 (5.5)
Secondary outcomes
Tampa Scale for Kinesiophobia (13–52) 28.0 (7.6) 28.2 (8.5) Pain Catastrophizing Scale (0–52) 20.4 (6.4) 20.8 (6.9) Numerical Rating Scale (0–10) 6.0 (1.0) 6.1 (1.2) Short-Form Health Survey
Physical function (0–100) 49.4 (10.2) 51.1 (11.5) Physical role (0–100) 41.2 (15.3) 44.1 (16.2) Bodily pain (0–100) 45.6 (14.8) 46.7 (16.0) General health (0–100) 39.2 (13.8) 38.8 (14.3) Vitality (0–100) 54.7 (15.8) 55.0 (14.2) Social function (0–100) 55.4 (12.7) 55.4 (11.5) Emotional role (0–100) 46.3 (16.3) 43.9 (15.6) Mental health (0–100) 51.3 (11.8) 52.0 (11.9)
aMean values (standard deviation).
Table 3. Changes over time within and between groups (n = 170).
Group Pretraininga Posttraininga Follow-upa Time
effectb Group effectb Interaction effectb
Primary outcome
Neck Disability Index
(0–100) MultidisciplinaryGeneral exercise 41.1 (39.8; 42.3) 36.7 (34.8; 38.6) 37.3 (35.4; 39.3)41.9 (40.7; 43.2) 24.3.(22.4; 26.2) 21.7 (19.7; 23.6) <0.001 <0.001 <0.001
Secondary outcomes
Tampa Scale for
Kinesiophobia (13–52) MultidisciplinaryGeneral exercise 28.2 (26.5; 30.0) 28.3 (26.7; 29.8) 29.1 (27.7; 30.6)28.0 (26.2; 29.7) 18.2 (16.6; 19.8) 16.8 (15.3; 18.2) <0.001 <0.001 <0.001 Pain Catastrophizing
Scale (0–52)
Multidisciplinary 20.4 (19.0; 21.9) 13.4 (12.9; 14.8) 12.2 (10.9; 13.5) <0.001 <0.001 <0.001 General exercise 20.8 (19.4; 22.2) 20.2 (18.8; 21.6) 21.2 (19.9; 22.5)
Numerical Rating
Scale (0–10) MultidisciplinaryGeneral exercise 6.0 (5.7; 6.2)6.1 (5.9; 6.3) 2.1 (1.8; 2.3)5.3 (5.1; 5.6) 2.1 (1.8; 2.3)5.6 (5.3; 5.8) <0.001 <0.001 <0.001
aEstimated marginal means (95% CI). bP-value (linear mixed model).
The questionnaires were complete for all ana-lysed patients owing to compliance monitoring by the secretaries. High compliance rates were found during the interventions (96%). Minor adverse effects were infrequent and consisted of transient pain worsening (multidisciplinary group: n = 8; general exercise group: n = 12) and mood disor-ders, i.e. anxiety and depression, (n = 5; n = 8). These were easily managed by means of sympto-matic drugs and brief periods of rest. Finally, no patients sought other treatments during the inter-vention period.
Discussion
The present study showed that a group-based mul-tidisciplinary programme including both multi-modal exercises and cognitive-behavioural therapy was superior to a group-based general physiother-apy in the management of subjects with chronic neck pain. The between-group differences were clinically meaningful for disability, pain relief, quality of life, kinesiophobia and catastrophizing, and were maintained at long-term. Small improve-ments were also achieved in the general exercise group for disability and quality of life, confirming
the importance of exercises for chronic neck pain.5 However, there were no changes in this group on psychological variables, probably because of the missing behavioural treatment component.
A clinically significant between-group differ-ence of 12 percentage points was achieved for dis-ability in favour of the multidisciplinary group after training. The observed treatment effect was larger than most other studies in the area4,5,11 and several aspects might explain these differences. First of all, our study overcomes some of the meth-odological shortcomings of previous trials. Indeed, 60% of the studies included in the Cochrane review10 had a high risk of bias owing, for exam-ple, to an inadequate sample size (<50 recruited patients). Furthermore, our multidisciplinary pro-gramme was systematic and comprehensive, as well as being theory-driven: it was based on a pre-cise and well-established model of change, includ-ing both physical and psychological components, linking specific cognitive modifications (fear-avoidance) to definite outcomes (disability, kinesi-ophobia and catastrophizing); it included graded task-oriented exercises in addition to cognitive-behavioural therapy, which may have contributed to enhancing functional outcomes, as well as a
Table 4. Changes over time within and between groups in terms of Short-Form Health Survey (n = 170).
Group Pretraininga Posttraininga Follow-upa Time
effectb Group effectb Interaction effectb Physical function
(0–100) MultidisciplinaryGeneral exercise 49.4 (47.1; 51.7)51.1 (48.8; 53.4) 80.1 (77.5; 82.7)62.0 (59.4; 64.6) 86.4 (83.7; 89.0)64.5 (61.9; 67.2) <0.001 <0.001 <0.001 Physical role
(0–100) MultidisciplinaryGeneral exercise 41.2 (37.8; 44.6)44.1 (40.7; 47.5) 80.1 (76.1; 84.1)63.3 (59.3; 67.4) 87.5 (83.7; 91.3)65.1 (61.3; 68.9) <0.001 <0.001 <0.001 Bodily pain
(0–100) MultidisciplinaryGeneral exercise 45.6 (42.3; 48.9)46.7 (43.4; 50.0) 71.6 (68.6; 74.7)56.4 (53.4; 59.5) 77.6 (74.4; 80.7)54.8 (51.6; 58.0) <0.001 <0.001 <0.001 General health
(0–100) MultidisciplinaryGeneral exercise 39.2 (36.2; 42.2)38.8 (35.8; 41.8) 72.9 (70.2; 75.6)57.8 (55.1; 60.5) 78.2 (74.8; 81.5)59.1 (55.7; 62.4) <0.001 <0.001 <0.001 Vitality (0–100) Multidisciplinary 54.7 (51.5; 57.9) 78.8 (76.2; 81.4) 80.9 (78.0; 83.8) <0.001 <0.001 <0.001
General exercise 55.0 (51.8; 58.2) 63.5 (60.9; 66.1) 62.3 (59.3; 65.2) Social function
(0–100) MultidisciplinaryGeneral exercise 55.4 (52.8; 58.0)55.4 (52.8; 58.0) 79.6 (76.8; 82.3)64.6 (61.8; 67.4) 83.2 (80.6; 85.9)63.3 (60.7; 66.0) <0.001 <0.001 <0.001 Emotional role
(0–100)
Multidisciplinary 46.3 (42.9; 49.7) 80.9 (76.6; 85.1) 82.8 (78.7; 86.8) <0.001 <0.001 <0.001 General exercise 43.9 (40.5; 47.3) 59.0 (54.7; 63.4) 53.4 (49.4; 57.5)
Mental health
(0–100) MultidisciplinaryGeneral exercise 51.3 (48.8; 53.9)52.0 (49.4; 54.5) 84.8 (82.5; 87.2)62.7 (60.3; 65.1) 88.2 (85.7; 90.7)67.9 (65.4; 70.4) <0.001 <0.001 <0.001
aEstimated marginal means (95% CI). bP-value (linear mixed model).
faster return to usual activities. As well, it was characterized by a longer duration to increase the likelihood of long-lasting improvements.
Our findings suggested that strategies including modification of avoidance beliefs, peer-group support and challenging of maladaptive cognitions induced positive attitudes toward active exercises and graded recovery of physical performance. The further improvement in disability at follow-up was likely related to the reduction of kinesiophobia, which was only found in the multidisciplinary group.30
Pain perception had decreased in the multidisci-plinary group by the end of treatment and this was maintained for at least one year, suggesting the importance of functional exercises and cognitive-behavioural therapy in sustaining modified pain perception effectively in chronic populations.
The perceived quality of life improved in both groups by the end of treatment; however, to a clini-cally significant extent (>30%) only in the multi-disciplinary group. These changes were maintained also at follow-up, suggesting the potential benefits of multidisciplinary interventions in relation to physical and mental domains of this instrument.
Evaluation of the perceived global effects also demonstrated better levels of treatment satisfaction in the multidisciplinary group. This was favoured by the presence of a well-integrated multidiscipli-nary team who, concordantly, contributed towards treatment goals.
This randomized controlled trial had a high level of internal validity as it was capable of distin-guishing effects in the two groups. It was ade-quately sized, involved concealed randomization and effective masking of assessors and analysts. The support of relatives helped to create a pro-tected environment, limit the drop-out rate and minimize adverse effects.
It is worth noting that the multidisciplinary pro-gramme has to be considered at low-cost, as about 110 euros are provided from the Italian healthcare system for the entire programme per patient. As expected, the innovative programme is slightly more expensive than traditional approaches based only on physical exercises (about 60 euros) but, given the positive findings described above, this intervention might have a crucial role in preventing
additional costs owing to the excessive use of pain-killers, as well as limitations in usual life activities owing to high levels of kinesiophobia.
This study has some limitations. First, there were differences in the contact-time between the treatment groups owing to the psychological inter-vention. Future studies could better control for this attention bias by using equivalently timed group sessions for controls, with low-level education or social workers, while excluding the cognitive-behavioural therapy elements critical to our study. Second, treatment expectations were not addressed. This possible confounding factor was only partly accounted for by telling the patients that the effectiveness of both treatments had not been established yet. Third, the fact that only two physiotherapists, although equally experienced, were separately responsible for each group, might have affected the results. A future replication of this study in other settings (outside of Italy) and with other physiotherapists might strengthen our findings. Fourth, the physiotherapists and the psy-chologist could not be blinded to treatment alloca-tion, potentially influencing patients’ expectations and adding a positive treatment effect with their higher enthusiasm and attention. Finally, it was not possible to identify which of the two compo-nents of the multidisciplinary intervention (multi-modal exercises or cognitive-behavioural therapy) may have had more effect.
The sample was representative of the general population undergoing rehabilitation for chronic neck pain in Italy.4 The recruited subjects scored moderately high at baseline on the various out-come measures. Though our findings may not be generalizable to more severely affected popula-tions, it may be considered as a first-choice treat-ment option in subgroups of patients with baseline scores similar to ours who visited a secondary care rehabilitation hospital. Furthermore, the described intervention cannot be delivered in every rehabilitation setting as it requires qualified staff specialized in chronic pain management and a rehabilitation team specialized in cognitive-behavioural therapy.
In conclusion, our findings suggest that a group-based multidisciplinary rehabilitation including
both multimodal exercises and cognitive-behav-ioural therapy was effective in improving disabil-ity, pain and quality of life in subjects with chronic neck pain. Changes were maintained for at least one year after the intervention ended.
Clinical message
•
• A group-based multidisciplinary rehabil-itation programme consisting of multi-modal exercises integrated with cognitive-behavioural therapy was supe-rior to group-based general physiother-apy in improving disability, pain and quality of life of subjects with chronic neck pain.
•
• These effects were maintained for at least 12 months.
Acknowledgements
The authors would like to thank all of the health profes-sionals and patients who took part in the study.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publica-tion of this article.
Contributors
• Marco Monticone had a role in study concept and design, acquisition of subjects and data, analysis and interpretation of data, and preparation of the manuscript; he drafted the article, and gave the final approval of the version to be published; • Emilia Ambrosini had a role in study concept
and design, statistical analysis and interpretation of data, and preparation of the manuscript; she drafted the article, and gave the final approval of the version to be published;
• Barbara Rocca had a role in study concept and design, acquisition of subjects and data, analysis and interpretation of data, and preparation of the manuscript; she revised it critically for impor-tant intellectual content, and gave final approval of the version to be published;
• Daniele Cazzaniga had a role in study concept and design, collection of data and preparation of the manuscript; he revised it critically for
important intellectual content, and gave the final approval of the version to be published; • Valentina Liquori had a role in study concept
and design, collection of data, and preparation of the manuscript; she revised it critically for important intellectual content and gave the final approval of the version to be published; • Alessandra Pedrocchi had a role in study
con-cept and design, analysis and interpretation of data, and preparation of the manuscript; he revised it critically for important intellectual content and gave the final approval of the ver-sion to be published.
• Howard Vernon had a role in study concept and design, analysis and interpretation of data, and preparation of the manuscript; he revised it criti-cally for important intellectual content and gave the final approval of the version to be published.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
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