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Correspondence Abstract
Marco Monticone
E-mail: marco.monticone@fsm.it Background: There are still doubts concerning the clinical impact of
multidisciplinary cognitive behavioural rehabilitation programmes
Funding sources conducted in group-based settings and about their long-term effects on
None. subjects with chronic low back pain (CLBP). This randomized, parallel-
group superiority-controlled trial aimed at evaluating the effect of such a
Conflicts of interest
programme on disability, kinesiophobia, catastrophizing, pain and
None declared.
quality of life in CLBP.
Methods: One hundred and fifty patients were randomly assigned to a
Accepted for publication 5-week group-based multidisciplinary programme of task-oriented
12 June 2015 exercises integrated with cognitive behavioural therapy mainly aimed at
managing kinesiophobia (experimental group, 75 subjects) or group-
doi:10.1002/ejp.756
based traditional exercises (control group, 75 subjects). Before
treatment, 5 weeks later (post-treatment), 12 and 24 months after the
end of treatment, the Oswestry Disability Index, the Tampa Scale for
Kinesiophobia, the Pain Catastrophizing Scale, a pain Numerical Rating
Scale and the Short Form Health Survey were assessed. A linear mixed
model for repeated measures was used for each outcome measure.
Results: Significant group (p < 0.001), time (p < 0.001) and time-by-
group interaction (p < 0.001) effects were found on disability, with a
between-group difference (95% confidence interval) after training in
favour of the experimental group of 10 ( 12; 8). Also kinesiophobia,
catastrophizing, pain, and quality of life improved to a significantly
greater extent in the experimental group. The improvements of the
experimental group were maintained at follow-ups.
Conclusion: This light group-based multidisciplinary cognitive
behavioural rehabilitation programme was superior to traditional
exercises in reducing disability, kinesiophobia, catastrophizing, and
enhancing the quality of life of subjects with CLBP. The effects lasted for
at least 2 years after the end of the intervention.
© 2015 European Pain Federation - EFICâ Eur J Pain 20 (2016) 541--551 541
Group-based training for chronic low back pain M. Monticone et al.
What’s already known about this topic? group-based settings as well as their long-term
effects (Brox et al., 2008; Chou and Huffman, 2007;
• Chronic low back pain is not only mechanically
related to spinal pathophysiology but it also Henschke et al., 2010; Van Middelkoop et al., 2011;
involves several psychological factors. Storheim et al., 2003). Evidence is also needed in
defining the characteristics of the exercises deliv-
• Individual-based multidisciplinary programmes
combining cognitive behavioural therapy with ered. As shown in previous studies (Dufour et al.,
physical training improve disability and reduce 2010; K€ a€
ap€a et al., 2006; Rose et al., 1997; Tavafian
maladaptive thoughts and behaviours. et al., 2011; Wertli et al., 2014), traditional exer-
cises concentrated on strengthening, stretching and
increasing the lumbar range of motion. Equal
What does this study add? improvements at the 1-year follow-up visit were
• Multidisciplinary cognitive behavioural rehabil- found in subjects with CLBP who were randomized
itation showed effectiveness regarding disabil- to group-based cognitive intervention and exercise
ity, fear-avoidance beliefs, pain and the quality or to instrumented lumbar fusion (Brox et al.,
of life even when performed in group-based 2003, 2006, 2010). Task-oriented exercises aimed at
settings. early functional recovery and independence in
• Improvements were maintained in the long activities of daily living (ADL) are arousing interest
term (at least 2 years after the end of the inter- (Van Middelkoop et al., 2011), but their efficacy
vention). has not yet been demonstrated. Moreover, previous
studies included a wide range of cognitive beha-
vioural interventions, such as problem solving,
According to bio-psychosocial models, CLBP is not restructuring of maladaptive thinking patterns,
only mechanically related to spinal pathophysiology relaxation, management of fear-avoidance beha-
but may also be influenced by attitudes, beliefs and viours and maladaptive coping strategies, but fur-
behaviours (Waddell, 2004). Psychological factors, ther evidence is required to better define which
such as mood alterations, catastrophizing, fear-avoid- should be the preferred approach when group-based
ance beliefs, and maladaptive coping strategies, are multidisciplinary rehabilitation is planned (Dufour
recognized as important determinants of chronic et al., 2010; K€ a€
ap€ a et al., 2006; Rose et al., 1997;
symptoms and disability (Pincus et al., 2002). Cur- Tavafian et al., 2011).
rent models of CLBP behaviour suggest that fear of The hypothesis underlying this study was that a
pain is more important than the pain intensity itself, 5-week multidisciplinary rehabilitation programme
preventing regain of normal functions, promoting of group-based task-oriented exercises integrated
the development of guarded movements, illness with CBT mainly aimed at managing the fear of
behaviours, and contributing to long-lasting disabil- movement would induce long-term improvements
ity and pain (Vlaeyen and Linton, 2000; Vlaeyen in disability, kinesiophobia, catastrophizing, pain and
et al., 1995). QoL in subjects with CLBP. The aim of this random-
Multidisciplinary programmes based on cognitive ized controlled study was to evaluate the efficacy of
behavioural therapy (CBT) have been increasingly such a programme when compared with traditional
used in addition to other therapies such as exercise, exercises.
to alter maladaptive thoughts and behaviours,
improve lumbar function and enhance the use of
2. Methods
self-management skills (Jensen et al., 2005; Johnson
et al., 2007; Van Middelkoop et al., 2011; Monti-
2.1 Design
cone et al., 2013; Morley, 2011; Vibe Fersum et al.,
2013). One recent pilot randomized controlled trial This randomized, parallel-group superiority-con-
showed the short-term effectiveness of an individ- trolled trial was conducted at the Operative Unit of
ual-based 8-week multidisciplinary cognitive beha- Physical Medicine and Rehabilitation of Salvatore
vioural programme in improving disability, Maugeri Foundation’s Scientific Institute in Lissone,
kinesiophobia, catastrophizing, and quality of life Italy. The staff involved has documented skills in
(QoL) of CLBP subjects (Monticone et al., 2014). spinal rehabilitation and CBT pain management and
However, there are still doubts concerning the clini- annually attends a theoretical and practical refresher
cal impact of these programmes, when conducted in course on the management of CLBP.
542 Eur J Pain 20 (2016) 541--551 © 2015 European Pain Federation - EFICâ
M. Monticone et al. Group-based training for chronic low back pain
Immediately after the patients had given their individually, based on the physical examination at
consent, the physiatrists mailed the principal investi- baseline of spinal postural, muscular, and articular
gator, who randomized the subjects to one of the performances. Both programmes were carried out in
two treatment programmes using a list of blinded small groups, each consisting of five patients, but
treatment codes previously generated by a biostatisti- each patient performed different exercises during the
cian using an automatic assignment system to assure group-based intervention.
the concealment of the allocation.
The principal investigator obtaining and assessing 2.3.1 Experimental group
the data and the biostatistician making the analyses,
Basic exercises were firstly introduced to improve
were both blinded to the treatment allocation. The
spinal mobility and deep muscle awareness; the
physiatrists, the psychologist, the physiotherapists
patients specifically learnt techniques for the local
and the patients could not be blinded.
muscles mainly involved (e.g. lumbar multifidus,
The study was approved by our hospital’s Institu-
transversus abdominis and obliquus abdominis inter-
tional Review Board (number: 10; date of approval:
nus), progressively increasing the speed and com-
12 November 2010), and was conducted in confor-
plexity of the movement patterns (O’Sullivan, 2000).
mity with ethical and humane principles of research.
Subsequently, the physical training consisted of task-
oriented exercises, such as moving from the couch
2.2 Participants to the sitting position, from a sitting to a standing
The inclusion criteria were a diagnosis of non-speci- position, ascending/descending stairs, climbing obsta-
fic CLBP (i.e. a documented history of pain lasting cles while maintaining spinal deep muscle activation,
>3 months), a good understanding of Italian and an aimed at gradually improving mobility and strength
age of >18 years. The exclusion criteria were cogni- of the lumbar spine, recovering segmentary stretch-
tive impairment and all causes of specific LBP, such ing involving back muscles, and improving postural,
as previous spinal surgery, deformity, infection, frac- proprioception and neuromotor control of the spine
ture or malignancy and systemic or neuromuscular and limbs. Additional exercises, such as turning,
diseases. Any subjects who had previously received standing on unstable surfaces and walking while
CBT were also excluded. changing speed and direction, were aimed at recov-
Outpatients were consecutively included in the ering coordination, balance and walking abilities as
study between January and December 2011. All of well as other functional demands of daily living.
the patients were evaluated by two physiatrists and Under the supervision of a clinical psychologist,
coordinated by the principal investigator, and those the patients were also involved in group-based
satisfying the entry criteria were then given further CBT aimed at modifying fear of movement beliefs,
information and asked to declare their willingness to and ensuring gradual reactions to illness beha-
comply with whichever treatment option they were viours. After explaining the fear-avoidance model,
randomly assigned to, and to attend all of the fol- patients were educated to view pain as a situation
low-up visits. that can be self-managed rather than a serious dis-
To partially limit expectation bias and to reduce ease needing vigilant protection (Vlaeyen and Lin-
problems of crossover, patients were blinded to the ton, 2000; Vlaeyen et al., 1995). The
study’s hypothesis by telling them the trial was main situations avoided were identified on the
intended to compare two common approaches to basis of the fear-avoidance beliefs emerging from
chronic LBP rehabilitation, whose efficacy had not the group discussion regarding the activities more
yet been established. Those who agreed were asked frequently reported, the administered question-
to sign an informed consent form, and subsequently naires and the presentation of images showing
their demographic data, symptoms and medical his- back-stressing activities. Specific questions were
tory were recorded. also formulated to investigate patients’ beliefs con-
cerning causes of pain, characteristics of persisting
pain, specific movements supposed to produce
2.3 Interventional programmes
spinal harm, actions believed to cause re-injuring
These involved two physiatrists, a psychologist, and and/or making pain worse, capability to carry out
four physiotherapists, separately responsible for the work duties, capability to perform daily activities,
physical training in the two interventional pro- fear of not being believed and/or helped by other
grammes. The exercise programme was planned people, fear of hopeless and miserable future life,
© 2015 European Pain Federation - EFICâ Eur J Pain 20 (2016) 541--551 543
Group-based training for chronic low back pain M. Monticone et al.
common treatments for CLBP. Whenever fear- ing exercises aimed at developing motor control of
avoidance behaviours of a single subject were the spine and pelvis).
revealed, these were shared and debated within
the whole group to identify the most suitable solu- 2.3.3 General recommendations
tions, as correct re-learning and cognitive restruc- Ergonomic advice was provided to both groups by
turing were based on developing an awareness of means of a booklet given to the patients during the
the problem and seeking a means of reacting to first session of treatment to facilitate the modifica-
frightening thoughts. Solutions were provided by tion of their daily living activities.
educating subjects on the nature of chronic pain: The interventional programmes lasted 5 weeks:
information on chronic conditions (e.g. “your hurts both groups were involved in two weekly 1-h ses-
will not harm you because a hyper-sensitized ner- sions of physical training, and, in addition, the
vous system uses pain to protect you at all costs, experimental group met with the psychologist once
but not to inform you about real damage”) had to a week for a 1-h session. At the end of treatment,
be retained, understood and applied to current the patients were asked to continue the taught exer-
problems to reduce the threat of pain itself as well cises actively at home.
as to change how they see themselves and behave; To ensure that there was no variability in the
subjects were encouraged to combine pain physiol- administration of treatment throughout the course
ogy with active and paced movement approaches of the study, a fidelity check, based on a treatment
to gradually increase physical capacity, reduce pain manual for the administration of exercise training
and improve quality of life (e.g. ‘get to know your and management of kinesiophobia, was conducted
pain and learn with patience and persistence how both during each session and at the end of the pro-
to move and to do things at work, at home, dur- gramme.
ing leisure time, despite an hyper-sensitized sys- No other treatments (e.g. physical modalities,
tem’). Relaxation as well as attentional techniques nerve blocks) were offered once patients were
such as distraction and desensitizing were shared accepted for the programme; patients were also disal-
with the subjects to facilitate graded exposure and lowed from taking major pharmacological agents
control over pain (also during flare-ups). More- such as opioids, steroids, anticonvulsants and antide-
over, advice to develop helpful ways of thinking pressant analgesics, while mild analgesics and
were provided to master fearful situations and to NSAIDs were permitted. Family doctors were also
minimize the level of distress (e.g. ‘stay calm, asked to avoid giving referrals for any other treat-
avoid extreme reactions, remind yourself you have ments while the participants were undergoing the
had pain like this before and you know it will get programmes.
better’); ways to challenge and change unhelpful Spouses, significant others or parents were asked
way of thinking were also encouraged to keep to support patients’ compliance during the study and
under control mood disorders (e.g. ‘when you get to inform the staff promptly if any difficulty was
panicky, or you feel anxious, depressed, irritable, encountered, to strengthen treatment adhesion and
stop and listen to what you have been saying to minimize drop-outs. To enhance compliance, the
yourself and ask yourself: is it helpful to think like patients were also asked to fill out a diary after each
that?’). training session and the physiotherapists checked the
Based on a close collaboration between the psy- diary every week.
chologist and the physiotherapists, the fear-avoid-
ance beliefs coming out were used to choose the
2.4 Outcome measures
task-oriented exercises to perform to outline an
exposition treatment to feared movement. Disability (primary outcome) was assessed using the
validated Italian version of the self-reported 10-item
Oswestry Disability Questionnaire (ODI) (Monticone
2.3.2 Control group
et al., 2009, 2012a), which allows a comprehensive
The usual-care rehabilitation included exercises for evaluation of back problems. The total score varies
passive spinal mobilization (including passive mobi- from 0 (no disability) to 100 (maximum disability).
lization to improve lumbar range of motion), Kinesiophobia was assessed using the validated
strengthening (involving abdominal and back mus- Italian 13-item version of the self-report Tampa Scale
cles), muscle segmentary stretching (including lower for Kinesiophobia (TSK) (Monticone et al., 2010),
limb and back muscles) and postural control (involv- with the reversed items removed. Each item is
544 Eur J Pain 20 (2016) 541--551 © 2015 European Pain Federation - EFICâ
M. Monticone et al. Group-based training for chronic low back pain
scored using a four-point Likert scale ranging from 1 patients were required, but 150 were actually
(strongly disagree) to 4 (strongly agree), and the recruited to allow for a drop-out rate of 10%. Linear
total score is calculated by adding the scores of the mixed model analyses for repeated measures (signifi-
individual items (range 13–52). cance level of 5%) were made of each of the out-
Catastrophizing was evaluated by means of the come measures, with group and time entered as
13-item validated Italian version of the self-reported fixed effects and the outcome measures as depen-
Pain Catastrophizing Scale (PCS), with each item dent variables. The time-by-group interaction term
being scored using a five-point scale (0 = never; was also evaluated. Since an intention-to-treat anal-
4 = always) (Monticone et al., 2012b). The total ysis was conducted, the linear mixed model was
score is calculated by adding the scores of the items selected to better deal with missing data (Fielding
(range 0–52), with higher scores representing greater et al., 2012; Siddiqui et al., 2009). If a significant
catastrophizing. time effect was found, pairwise comparisons between
Pain was assessed using an 11-point Numerical baseline and all the other assessment time points
Rating Scale (NRS) ranging from 0 (no pain at all) to were analysed for the two groups, separately.
10 (the worst imaginable pain) (Huskisson, 1974). Between-group differences for each time point were
Quality of life was assessed using the Italian ver- also evaluated for the primary outcome and the psy-
sion of the self-report Short Form Health Survey chological variables. Because of its categorical nat-
(SF-36) (Apolone and Mosconi, 1998; Apolone et al., ure, GPE was analysed using the Mann–Whitney U
2000), and its eight domain scores were calculated test.
on the basis of the User’s Manual of the Italian ver- The data were analysed using SPSS 22.0 software.
sion, with 0 representing the worst perceived QoL
and 100 the best perceived QoL.
3. Results
The questionnaires were completed before treat-
ment, 5 weeks later (post-training), 12 (12M follow- The study was conducted between January 2011 and
up) and 24 months after the end of treatment (24M February 2014. Fig. 1 shows the study flow chart:
follow-up). 188 patients were screened, and 150, who agreed to
During the treatment period, the questionnaires participate, were then randomized. Three subjects
were then administered by secretarial staff who dropped out from the study before the end of the
checked them and returned any uncompleted part to intervention (experimental group:1; control
the patients for completion. At follow-ups, the group:2); a further 18 patients were lost during fol-
patients were contacted personally by the same sec- low-ups, 9 at 12-month (experimental group:4; con-
retarial staff to ensure that the questionnaires were trol group:5), and 9 at 24-month follow-up
properly completed. (experimental group:5; control group:4). No cross-
At the end of treatment, the patients were also over problems arose as no patient asked to swap
asked to rate the efficacy of treatment using the Glo- groups. All of the recruited patients were included in
bal Perceived Effect scale (GPE), which is a 5-point the analysis.
Likert scale (1 = helped a lot, 2 = helped, 3 = helped Table 1 shows the clinical and demographical
only a little, 4 = did not help, 5 = made things characteristics of the participants. The two groups
worse) (Kamper et al., 2010). were similar in terms of age, body mass index, pain
Using a specific form, the patients were asked to duration and outcome measures at baseline.
report any serious and/or distressing symptoms they Tables 2 and 3 report the changes over time
experienced during the study that required further within and between the two groups for the primary
treatment. and secondary outcome measures. For all outcomes,
a significant effect of time (p < 0.001), group
(p < 0.001) and time-by-group interaction
2.5 Statistics
(p < 0.001) were found. Table 4 reports the p-values
The sample size was computed using the Italian ver- of the pairwise comparisons between baseline and all
sion of the ODI, for which it was estimated that a the other assessment time points.
between-group difference of 10 points should be A significant difference between baseline and post-
considered as clinically important (Monticone et al., treatment score (p < 0.001) was found for the pri-
2012a). To assure 95% statistical power and 5% type mary outcome (ODI) in both groups, but the experi-
I error, and considering a standard deviation of 16 mental group improved more and a significant
points (see table 2 in Monticone et al., 2012a), 135 between-group change (95% confidence interval,
© 2015 European Pain Federation - EFICâ Eur J Pain 20 (2016) 541--551 545
Group-based training for chronic low back pain M. Monticone et al.
CI) of 9.9 ( 11.6; 8.2) was achieved after the in terms of catastrophizing, but the change was clini-
intervention (Fig. 2, panel A). The baseline score cally meaningful only for the experimental group
remained significantly different from the follow-up and a significant between-group change (95% CI) of
assessments in both groups (p < 0.001, Table 4), but 12.4 ( 14.1; 10.7) was found after training
a small trend of deterioration was visible in the con- (Fig. 2, panel C). In the experimental group, the
trol group, leading to a small increase in the baseline score remained significantly different from
between-group change (Fig 2, panel A). both follow-ups, while no changes between baseline
As for kinesiophobia, a significant between-group and follow-ups were found in the control group.
change (95% CI) of 9.2 ( 11.0; 7.3) was Concerning pain and QoL, significant improve-
observed in favour of the experimental group at the ments were found in both groups after training
end of the intervention (Fig. 2, panel B). In the (p < 0.001), but the experimental group improved
experimental group, the baseline score was signifi- more and maintained all of the improvements
cantly worse than all the other assessments, suggest- achieved at follow-ups. On the contrary, the control
ing that the improvement achieved after training group did not preserve the slight changes achieved
was maintained up to 2 years after the end of the after training for some sub-scales of the SF-36 (Bod-
intervention. In the control group, the baseline score ily pain, Vitality, Social Function, and Emotional
significantly improved after training (Table 4), but Role).
this difference was not clinically meaningful (change Finally, a significant between-group difference was
<2 points); a slight but significant worsening was found in terms of GPE (p < 0.001), as reported in
instead visible at 1-year and 2-year follow-up. Table 5. The odds ratio (95% CI) of successful train-
At the end of the intervention, both groups ing (GPE score = 1–2) for the experimental versus
achieved a significant improvement (p < 0.001) also the control group was 35.9 (10.3; 124.9), strongly
546 Eur J Pain 20 (2016) 541--551 © 2015 European Pain Federation - EFICâ
M. Monticone et al. Group-based training for chronic low back pain
Table 1 Baseline clinical and demographic characteristics of study easily managed by means of symptomatic drugs and
participants. psychological interventions.
Experimental Control
groupa (n = 75) groupa (n = 75)
4. Discussion and conclusions
Age (years) 53.2 (11.1) 53.8 (10.4)
Gender (male/female) 28/47 30/45 The results of this randomized trial show that a mul-
Body mass index (kg/m2) 26.9 (4.4) 26.3 (3.6) tidisciplinary programme of group-based task-ori-
Pain duration (months) 21.7 (15.0) 22.7 (15.9) ented exercises aimed at managing kinesiophobia
Irradiation (yes/no) 18/57 15/60 was superior to an exercise programme of similar
Primary outcome
duration in reducing disability, fear-avoidance
ODI (0–100) 34.4 (4.6) 32.4 (5.4)
beliefs, catastrophizing and pain, and enhancing the
Secondary outcomes
TSK (13–52) 27.5 (4.7) 28.5 (5.5) QoL of subjects with CLBP. The effects lasted for at
PCS (0–52) 27.8 (4.6) 26.4 (5.4) least 2 years after the end of the intervention.
NRS (0–10) 6.4 (1.7) 6.1 (1.6) A clinically significant between-group difference of
SF-36 10 points on disability was achieved after training in
Physical activity (0–100) 51.5 (10.0) 49.1 (12.1) favour of the experimental group. This finding is con-
Physical role (0–100) 42.3 (15.9) 42.7 (16.3)
sistent with a previous trial conducted by our research
Bodily pain (0–100) 44.3 (16.9) 46.3 (15.4)
group, which showed that a 13-month individual-
General Health (0–100) 39.8 (14.5) 38.5 (12.9)
Vitality (0–100) 54.2 (15.6) 55.9 (14.2) based multidisciplinary cognitive behavioural pro-
Social functioning (0–100) 54.3 (11.5) 56.2 (12.6) gramme including traditional spinal exercises was
Emotional role (0–100) 44.9 (18.6) 42.7 (15.1) effective for highly disabled CLBP subjects (Monticone
Mental health (0–100) 51.3 (11.6) 52.5 (12.7) et al., 2013). However, the use of task-oriented exer-
ODI, Oswestry Disability Index; TSK, Tampa Scale of Kinesiophobia; cises may have added value in enhancing functional
PCS, Pain Catastrophizing Scale; NRS, Numerical Rating Scale; SF-36, outcomes as well as a faster return to usual activities.
Short Form Health Survey. This is also consistent with our subsequent trial,
a
Mean value (standard deviation). which demonstrated the effectiveness of a 2-month
individual-based multidisciplinary programme includ-
ing task-oriented exercises, conducted on less
suggesting a higher satisfaction with treatment per- impaired subjects (Monticone et al., 2014); similar
ceived by the experimental group. trends to the previous findings were achieved at post-
The physiotherapists checked systematically the treatment also in the present study, suggesting that
patients’ treatments diaries and compliance rates whether subjects were treated individually or as part
were satisfactory in both groups (100%). Minor of a group did not affect the overall outcome (K€ a€
ap€
a
adverse effects of transient pain worsening (seven et al., 2006; Rose et al., 1997). Moreover, adopting a
subjects in the experimental group; five in the con- CBT mainly aimed at addressing fear-avoidance beliefs
trol group) and mood disorders (two subjects in the proved to be a successful strategy even when group-
experimental group; two in the control group) were based, additionally offering the opportunity for peer-
Table 2 Changes over time within and between the control and experimental group (n = 150).
Primary outcome
ODI (0–100) Experimental 34.4 (4.6) 15.5 (4.8) 11.9 (3.8) 15.0 (3.6) <0.001 (200.21) <0.001 (303.96) <0.001 (120.72)
Control 32.4 (5.4) 25.3 (5.5) 27.7 (6.4) 30.0 (6.0)
Secondary outcomes
TSK (13–52) Experimental 27.5 (4.7) 17.6 (5.3) 15.5 (4.8) 14.4 (4.1) <0.001 (180.32) <0.001 (126.95) <0.001 (163.15)
Control 28.5 (5.5) 26.8 (5.9) 29.6 (5.3) 29.9 (4.3)
PCS (0–52) Experimental 27.8 (4.6) 12.7 (5.3) 10.0 (5.1) 11.4 (3.7) <0.001 (254.90) <0.001 (255.60) <0.001 (785.99)
Control 26.4 (5.4) 25.1 (5.0) 26.7 (4.9) 27.1 (4.7)
NRS (0–10) Experimental 6.4 (1.7) 1.4 (1.2) 2.4 (1.5) 2.8 (1.0) <0.001 (82.65) <0.001 (130.23) <0.001 (29.31)
Control 6.1 (1.6) 4.5 (1.8) 4.2 (1.6) 4.7 (1.6)
ODI, Oswestry Disability Index; TSK, Tampa Scale of Kinesiophobia; PCS, Pain Catastrophizing Scale; NRS, Numerical Rating Scale.
a
Mean value (standard deviation).
© 2015 European Pain Federation - EFICâ Eur J Pain 20 (2016) 541--551 547
Group-based training for chronic low back pain M. Monticone et al.
Table 3 Changes over time within and between groups in terms of SF-36 (n = 150).
Secondary outcomes
SF-36
Physical Experimental 51.5 (10.0) 84.4 (9.4) 87.7 (9.4) 87.8 (9.3) <0.001 (313.37) <0.001 (158.02) <0.001 (48.16)
activity (0–100) Control 49.1 (12.1) 63.6 (11.2) 60.1 (9.1) 58.5 (11.5)
Physical Experimental 42.3 (15.9) 84.1 (19.2) 86.1 (15.7) 85.4 (19.2) <0.001 (146.50) <0.001 (120.22) <0.001(25.19)
role (0–100) Control 42.7 (16.3) 61.6 (15.6) 60.3 (14.5) 52.0 (17.4)
Bodily Experimental 44.3 (16.9) 73.0 (16.4) 76.3 (14.0) 74.7 (13.2) <0.001 (88.99) <0.001 (91.85) <0.001(53.57)
pain (0–100) Control 46.3 (15.4) 55.2 (13.0) 49.3 (13.0) 48.4 (10.3)
General Experimental 39.8 (14.5) 74.3 (11.9) 81.6 (13.4) 82.5 (13.4) <0.001 (183.65) <0.001 (181.34) <0.001(35.55)
Health (0–100) Control 38.5 (12.9) 57.6 (12.8) 55.7 (11.3) 53.7 (10.6)
Vitality Experimental 54.2 (15.6) 79.0 (11.7) 84.4 (10.1) 83.8 (9.1) <0.001 (82.75) <0.001 (105.12) <0.001(58.53)
(0–100) Control 55.9 (14.2) 63.8 (13.9) 61.4 (12.5) 57.8 (14.1)
Social Experimental 54.3 (11.5) 81.8 (11.6) 84.1 (12.8) 84.0 (11.4) <0.001 (137.34) <0.001 (111.47) <0.001(59.59)
function (0–100) Control 56.2 (12.6) 63.4 (10.9) 61.4 (9.6) 59.8 (10.1)
Emotional Experimental 44.9 (18.6) 75.7 (20.1) 80.0 (18.3) 82.1 (21.3) <0.001 (80.84) <0.001 (138.74) <0.001(57.47)
role (0–100) Control 42.7 (15.1) 53.9 (20.5) 45.6 (16.2) 44.8 (22.4)
Mental Experimental 51.3 (11.6) 86.3 (7.9) 89.9 (7.4) 88.4 (7.9) <0.001 (169.94) <0.001 (183.08) <0.001(58.44)
health (0–100) Control 52.5 (12.7) 62.5 (13.1) 64.4 (12.9) 61.4 (12.7)
Table 4 Pairwise comparisons between baseline and all the other assessment time points (n = 150).
Group p-value baseline vs. post-training p-value baseline vs. 12M follow-up p-value baseline vs. 24M follow-up
Primary outcome
ODI (0–100) Experimental <0.001 <0.001 <0.001
Control <0.001 <0.001 0.001
Secondary outcomes
TSK (13–52) Experimental <0.001 <0.001 <0.001
Control <0.001 0.004 0.001
PCS (0–52) Experimental <0.001 <0.001 <0.001
Control <0.001 0.502 0.253
NRS (0–10) Experimental <0.001 <0.001 <0.001
Control <0.001 <0.001 <0.001
SF-36
Physical activity (0–100) Experimental <0.001 <0.001 <0.001
Control <0.001 <0.001 <0.001
Physical role (0–100) Experimental <0.001 <0.001 <0.001
Control <0.001 <0.001 0.005
Bodily pain (0–100) Experimental <0.001 <0.001 <0.001
Control <0.001 0.061 0.324
General Health (0–100) Experimental <0.001 <0.001 <0.001
Control <0.001 <0.001 <0.001
Vitality (0–100) Experimental <0.001 <0.001 <0.001
Control <0.001 <0.001 0.201
Social function (0–100) Experimental <0.001 <0.001 <0.001
Control <0.001 0.001 0.042
Emotional role (0–100) Experimental <0.001 <0.001 <0.001
Control <0.001 0.108 0.345
Mental health (0–100) Experimental <0.001 <0.001 <0.001
Control <0.001 <0.001 <0.001
ODI, Oswestry Disability Index; TSK, Tampa Scale of Kinesiophobia; PCS, Pain Catastrophizing Scale; NRS, Numerical Rating Scale; SF-36, Short Form
Health Survey.
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