ORIGINAL ARTICLE

Group-based task-oriented exercises aimed at managing

kinesiophobia improved disability in chronic low back pain
M. Monticone1, E. Ambrosini1,2, B. Rocca1, D. Cazzaniga1, V. Liquori1, C. Foti3
1 Physical Medicine and Rehabilitation Unit, Scientific Institute of Lissone, Institute of Care and Research, Salvatore Maugeri Foundation IRCCS,
Lissone, Italy
2 Neuroengineering and Medical Robotics Laboratory, Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan,
Italy
3 Chair of Physical Medicine and Rehabilitation, University of Rome ‘Torvergata’, Rome, Italy

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.

health care services in Western countries, as it has a

1. Introduction
Chronic low back pain (CLBP) is one of the most
challenging problems for primary and secondary
prevalence of about 23%, with 11–12% of the popu-
lation being disabled, it tends not to improve with
time and consumes most resources (Krismer and van
Tulder, 2007; Balagu
e et al., 2012).

© 2015 European Pain Federation - EFICâ Eur J Pain 20 (2016) 541--551 541
Group-based training for chronic low back pain
What’s already known about this topic?
• Chronic low back pain is not only mechanically
related to spinal pathophysiology but it also
involves several psychological factors.
• Individual-based multidisciplinary programmes
combining cognitive behavioural therapy with
physical training improve disability and reduce
maladaptive thoughts and behaviours.
What does this study add?
• Multidisciplinary cognitive behavioural rehabil-
itation showed effectiveness regarding disabil-
ity, fear-avoidance beliefs, pain and the quality
of life even when performed in group-based
settings.
• Improvements were maintained in the long
term (at least 2 years after the end of the inter-
vention).
According to bio-psychosocial models, CLBP is not
only mechanically related to spinal pathophysiology
but may also be influenced by attitudes, beliefs and
behaviours (Waddell, 2004). Psychological factors,
such as mood alterations, catastrophizing, fear-avoid-
ance beliefs, and maladaptive coping strategies, are
recognized as important determinants of chronic
symptoms and disability (Pincus et al., 2002). Cur-
rent models of CLBP behaviour suggest that fear of
pain is more important than the pain intensity itself,
preventing regain of normal functions, promoting
the development of guarded movements, illness
behaviours, and contributing to long-lasting disabil-
ity and pain (Vlaeyen and Linton, 2000; Vlaeyen
et al., 1995).
Multidisciplinary programmes based on cognitive
behavioural therapy (CBT) have been increasingly
used in addition to other therapies such as exercise,
to alter maladaptive thoughts and behaviours,
improve lumbar function and enhance the use of
self-management skills (Jensen et al., 2005; Johnson
et al., 2007; Van Middelkoop et al., 2011; Monti-
cone et al., 2013; Morley, 2011; Vibe Fersum et al.,
2013). One recent pilot randomized controlled trial
showed the short-term effectiveness of an individ-
ual-based 8-week multidisciplinary cognitive beha-
vioural programme in improving disability,
kinesiophobia, catastrophizing, and quality of life
(QoL) of CLBP subjects (Monticone et al., 2014).
However, there are still doubts concerning the clini-
cal impact of these programmes, when conducted in
542 Eur J Pain 20 (2016) 541--551
M. Monticone et al.
group-based settings as well as their long-term
effects (Brox et al., 2008; Chou and Huffman, 2007;
Henschke et al., 2010; Van Middelkoop et al., 2011;
Storheim et al., 2003). Evidence is also needed in
defining the characteristics of the exercises deliv-
ered. As shown in previous studies (Dufour et al.,
2010; K€ a€
ap€a et al., 2006; Rose et al., 1997; Tavafian
et al., 2011; Wertli et al., 2014), traditional exer-
cises concentrated on strengthening, stretching and
increasing the lumbar range of motion. Equal
improvements at the 1-year follow-up visit were
found in subjects with CLBP who were randomized
to group-based cognitive intervention and exercise
or to instrumented lumbar fusion (Brox et al.,
2003, 2006, 2010). Task-oriented exercises aimed at
early functional recovery and independence in
activities of daily living (ADL) are arousing interest
(Van Middelkoop et al., 2011), but their efficacy
has not yet been demonstrated. Moreover, previous
studies included a wide range of cognitive beha-
vioural interventions, such as problem solving,
restructuring of maladaptive thinking patterns,
relaxation, management of fear-avoidance beha-
viours and maladaptive coping strategies, but fur-
ther evidence is required to better define which
should be the preferred approach when group-based
multidisciplinary rehabilitation is planned (Dufour
et al., 2010; K€ a€
ap€ a et al., 2006; Rose et al., 1997;
Tavafian et al., 2011).
The hypothesis underlying this study was that a
5-week multidisciplinary rehabilitation programme
of group-based task-oriented exercises integrated
with CBT mainly aimed at managing the fear of
movement would induce long-term improvements
in disability, kinesiophobia, catastrophizing, pain and
QoL in subjects with CLBP. The aim of this random-
ized controlled study was to evaluate the efficacy of
such a programme when compared with traditional
exercises.
2. Methods
2.1 Design
This randomized, parallel-group superiority-con-
trolled trial was conducted at the Operative Unit of
Physical Medicine and Rehabilitation of Salvatore
Maugeri Foundation’s Scientific Institute in Lissone,
Italy. The staff involved has documented skills in
spinal rehabilitation and CBT pain management and
annually attends a theoretical and practical refresher
course on the management of CLBP.
© 2015 European Pain Federation - EFICâ
M. Monticone et al.
Immediately after the patients had given their
consent, the physiatrists mailed the principal investi-
gator, who randomized the subjects to one of the
two treatment programmes using a list of blinded
treatment codes previously generated by a biostatisti-
cian using an automatic assignment system to assure
the concealment of the allocation.
The principal investigator obtaining and assessing
the data and the biostatistician making the analyses,
were both blinded to the treatment allocation. The
physiatrists, the psychologist, the physiotherapists
and the patients could not be blinded.
The study was approved by our hospital’s Institu-
tional Review Board (number: 10; date of approval:
12 November 2010), and was conducted in confor-
mity with ethical and humane principles of research.
2.2 Participants
The inclusion criteria were a diagnosis of non-speci-
fic CLBP (i.e. a documented history of pain lasting
>3 months), a good understanding of Italian and an
age of >18 years. The exclusion criteria were cogni-
tive impairment and all causes of specific LBP, such
as previous spinal surgery, deformity, infection, frac-
ture or malignancy and systemic or neuromuscular
diseases. Any subjects who had previously received
CBT were also excluded.
Outpatients were consecutively included in the
study between January and December 2011. All of
the patients were evaluated by two physiatrists and
coordinated by the principal investigator, and those
satisfying the entry criteria were then given further
information and asked to declare their willingness to
comply with whichever treatment option they were
randomly assigned to, and to attend all of the fol-
low-up visits.
To partially limit expectation bias and to reduce
problems of crossover, patients were blinded to the
study’s hypothesis by telling them the trial was
intended to compare two common approaches to
chronic LBP rehabilitation, whose efficacy had not
yet been established. Those who agreed were asked
to sign an informed consent form, and subsequently
their demographic data, symptoms and medical his-
tory were recorded.
2.3 Interventional programmes
These involved two physiatrists, a psychologist, and
four physiotherapists, separately responsible for the
physical training in the two interventional pro-
grammes. The exercise programme was planned
© 2015 European Pain Federation - EFICâ
Group-based training for chronic low back pain
individually, based on the physical examination at
baseline of spinal postural, muscular, and articular
performances. Both programmes were carried out in
small groups, each consisting of five patients, but
each patient performed different exercises during the
group-based intervention.
2.3.1 Experimental group
Basic exercises were firstly introduced to improve
spinal mobility and deep muscle awareness; the
patients specifically learnt techniques for the local
muscles mainly involved (e.g. lumbar multifidus,
transversus abdominis and obliquus abdominis inter-
nus), progressively increasing the speed and com-
plexity of the movement patterns (O’Sullivan, 2000).
Subsequently, the physical training consisted of task-
oriented exercises, such as moving from the couch
to the sitting position, from a sitting to a standing
position, ascending/descending stairs, climbing obsta-
cles while maintaining spinal deep muscle activation,
aimed at gradually improving mobility and strength
of the lumbar spine, recovering segmentary stretch-
ing involving back muscles, and improving postural,
proprioception and neuromotor control of the spine
and limbs. Additional exercises, such as turning,
standing on unstable surfaces and walking while
changing speed and direction, were aimed at recov-
ering coordination, balance and walking abilities as
well as other functional demands of daily living.
Under the supervision of a clinical psychologist,
the patients were also involved in group-based
CBT aimed at modifying fear of movement beliefs,
and ensuring gradual reactions to illness beha-
viours. After explaining the fear-avoidance model,
patients were educated to view pain as a situation
that can be self-managed rather than a serious dis-
ease needing vigilant protection (Vlaeyen and Lin-
ton, 2000; Vlaeyen et al., 1995). The
main situations avoided were identified on the
basis of the fear-avoidance beliefs emerging from
the group discussion regarding the activities more
frequently reported, the administered question-
naires and the presentation of images showing
back-stressing activities. Specific questions were
also formulated to investigate patients’ beliefs con-
cerning causes of pain, characteristics of persisting
pain, specific movements supposed to produce
spinal harm, actions believed to cause re-injuring
and/or making pain worse, capability to carry out
work duties, capability to perform daily activities,
fear of not being believed and/or helped by other
people, fear of hopeless and miserable future life,
Eur J Pain 20 (2016) 541--551 543
Group-based training for chronic low back pain
common treatments for CLBP. Whenever fear-
avoidance behaviours of a single subject were
revealed, these were shared and debated within
the whole group to identify the most suitable solu-
tions, as correct re-learning and cognitive restruc-
turing were based on developing an awareness of
the problem and seeking a means of reacting to
frightening thoughts. Solutions were provided by
educating subjects on the nature of chronic pain:
information on chronic conditions (e.g. “your hurts
will not harm you because a hyper-sensitized ner-
vous system uses pain to protect you at all costs,
but not to inform you about real damage”) had to
be retained, understood and applied to current
problems to reduce the threat of pain itself as well
as to change how they see themselves and behave;
subjects were encouraged to combine pain physiol-
ogy with active and paced movement approaches
to gradually increase physical capacity, reduce pain
and improve quality of life (e.g. ‘get to know your
pain and learn with patience and persistence how
to move and to do things at work, at home, dur-
ing leisure time, despite an hyper-sensitized sys-
tem’). Relaxation as well as attentional techniques
such as distraction and desensitizing were shared
with the subjects to facilitate graded exposure and
control over pain (also during flare-ups). More-
over, advice to develop helpful ways of thinking
were provided to master fearful situations and to
minimize the level of distress (e.g. ‘stay calm,
avoid extreme reactions, remind yourself you have
had pain like this before and you know it will get
better’); ways to challenge and change unhelpful
way of thinking were also encouraged to keep
under control mood disorders (e.g. ‘when you get
panicky, or you feel anxious, depressed, irritable,
stop and listen to what you have been saying to
yourself and ask yourself: is it helpful to think like
that?’).
Based on a close collaboration between the psy-
chologist and the physiotherapists, the fear-avoid-
ance beliefs coming out were used to choose the
task-oriented exercises to perform to outline an
exposition treatment to feared movement.
2.3.2 Control group
The usual-care rehabilitation included exercises for
passive spinal mobilization (including passive mobi-
lization to improve lumbar range of motion),
strengthening (involving abdominal and back mus-
cles), muscle segmentary stretching (including lower
limb and back muscles) and postural control (involv-
544 Eur J Pain 20 (2016) 541--551
M. Monticone et al.
ing exercises aimed at developing motor control of
the spine and pelvis).
2.3.3 General recommendations
Ergonomic advice was provided to both groups by
means of a booklet given to the patients during the
first session of treatment to facilitate the modifica-
tion of their daily living activities.
The interventional programmes lasted 5 weeks:
both groups were involved in two weekly 1-h ses-
sions of physical training, and, in addition, the
experimental group met with the psychologist once
a week for a 1-h session. At the end of treatment,
the patients were asked to continue the taught exer-
cises actively at home.
To ensure that there was no variability in the
administration of treatment throughout the course
of the study, a fidelity check, based on a treatment
manual for the administration of exercise training
and management of kinesiophobia, was conducted
both during each session and at the end of the pro-
gramme.
No other treatments (e.g. physical modalities,
nerve blocks) were offered once patients were
accepted for the programme; patients were also disal-
lowed from taking major pharmacological agents
such as opioids, steroids, anticonvulsants and antide-
pressant analgesics, while mild analgesics and
NSAIDs were permitted. Family doctors were also
asked to avoid giving referrals for any other treat-
ments while the participants were undergoing the
programmes.
Spouses, significant others or parents were asked
to support patients’ compliance during the study and
to inform the staff promptly if any difficulty was
encountered, to strengthen treatment adhesion and
minimize drop-outs. To enhance compliance, the
patients were also asked to fill out a diary after each
training session and the physiotherapists checked the
diary every week.
2.4 Outcome measures
Disability (primary outcome) was assessed using the
validated Italian version of the self-reported 10-item
Oswestry Disability Questionnaire (ODI) (Monticone
et al., 2009, 2012a), which allows a comprehensive
evaluation of back problems. The total score varies
from 0 (no disability) to 100 (maximum disability).
Kinesiophobia was assessed using the validated
Italian 13-item version of the self-report Tampa Scale
for Kinesiophobia (TSK) (Monticone et al., 2010),
with the reversed items removed. Each item is
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M. Monticone et al.
scored using a four-point Likert scale ranging from 1
(strongly disagree) to 4 (strongly agree), and the
total score is calculated by adding the scores of the
individual items (range 13–52).
Catastrophizing was evaluated by means of the
13-item validated Italian version of the self-reported
Pain Catastrophizing Scale (PCS), with each item
being scored using a five-point scale (0 = never;
4 = always) (Monticone et al., 2012b). The total
score is calculated by adding the scores of the items
(range 0–52), with higher scores representing greater
catastrophizing.
Pain was assessed using an 11-point Numerical
Rating Scale (NRS) ranging from 0 (no pain at all) to
10 (the worst imaginable pain) (Huskisson, 1974).
Quality of life was assessed using the Italian ver-
sion of the self-report Short Form Health Survey
(SF-36) (Apolone and Mosconi, 1998; Apolone et al.,
2000), and its eight domain scores were calculated
on the basis of the User’s Manual of the Italian ver-
sion, with 0 representing the worst perceived QoL
and 100 the best perceived QoL.
The questionnaires were completed before treat-
ment, 5 weeks later (post-training), 12 (12M follow-
up) and 24 months after the end of treatment (24M
follow-up).
During the treatment period, the questionnaires
were then administered by secretarial staff who
checked them and returned any uncompleted part to
the patients for completion. At follow-ups, the
patients were contacted personally by the same sec-
retarial staff to ensure that the questionnaires were
properly completed.
At the end of treatment, the patients were also
asked to rate the efficacy of treatment using the Glo-
bal Perceived Effect scale (GPE), which is a 5-point
Likert scale (1 = helped a lot, 2 = helped, 3 = helped
only a little, 4 = did not help, 5 = made things
worse) (Kamper et al., 2010).
Using a specific form, the patients were asked to
report any serious and/or distressing symptoms they
experienced during the study that required further
treatment.
2.5 Statistics
The sample size was computed using the Italian ver-
sion of the ODI, for which it was estimated that a
between-group difference of 10 points should be
considered as clinically important (Monticone et al.,
2012a). To assure 95% statistical power and 5% type
I error, and considering a standard deviation of 16
points (see table 2 in Monticone et al., 2012a), 135
© 2015 European Pain Federation - EFICâ
Group-based training for chronic low back pain
patients were required, but 150 were actually
recruited to allow for a drop-out rate of 10%. Linear
mixed model analyses for repeated measures (signifi-
cance level of 5%) were made of each of the out-
come measures, with group and time entered as
fixed effects and the outcome measures as depen-
dent variables. The time-by-group interaction term
was also evaluated. Since an intention-to-treat anal-
ysis was conducted, the linear mixed model was
selected to better deal with missing data (Fielding
et al., 2012; Siddiqui et al., 2009). If a significant
time effect was found, pairwise comparisons between
baseline and all the other assessment time points
were analysed for the two groups, separately.
Between-group differences for each time point were
also evaluated for the primary outcome and the psy-
chological variables. Because of its categorical nat-
ure, GPE was analysed using the Mann–Whitney U
test.
The data were analysed using SPSS 22.0 software.
3. Results
The study was conducted between January 2011 and
February 2014. Fig. 1 shows the study flow chart:
188 patients were screened, and 150, who agreed to
participate, were then randomized. Three subjects
dropped out from the study before the end of the
intervention (experimental group:1; control
group:2); a further 18 patients were lost during fol-
low-ups, 9 at 12-month (experimental group:4; con-
trol group:5), and 9 at 24-month follow-up
(experimental group:5; control group:4). No cross-
over problems arose as no patient asked to swap
groups. All of the recruited patients were included in
the analysis.
Table 1 shows the clinical and demographical
characteristics of the participants. The two groups
were similar in terms of age, body mass index, pain
duration and outcome measures at baseline.
Tables 2 and 3 report the changes over time
within and between the two groups for the primary
and secondary outcome measures. For all outcomes,
a significant effect of time (p < 0.001), group
(p < 0.001) and time-by-group interaction
(p < 0.001) were found. Table 4 reports the p-values
of the pairwise comparisons between baseline and all
the other assessment time points.
A significant difference between baseline and post-
treatment score (p < 0.001) was found for the pri-
mary outcome (ODI) in both groups, but the experi-
mental group improved more and a significant
between-group change (95% confidence interval,
Eur J Pain 20 (2016) 541--551 545
Group-based training for chronic low back pain
Figure 1 Study flow chart.
CI) of 9.9 ( 11.6; 8.2) was achieved after the
intervention (Fig. 2, panel A). The baseline score
remained significantly different from the follow-up
assessments in both groups (p < 0.001, Table 4), but
a small trend of deterioration was visible in the con-
trol group, leading to a small increase in the
between-group change (Fig 2, panel A).
As for kinesiophobia, a significant between-group
change (95% CI) of 9.2 ( 11.0; 7.3) was
observed in favour of the experimental group at the
end of the intervention (Fig. 2, panel B). In the
experimental group, the baseline score was signifi-
cantly worse than all the other assessments, suggest-
ing that the improvement achieved after training
was maintained up to 2 years after the end of the
intervention. In the control group, the baseline score
significantly improved after training (Table 4), but
this difference was not clinically meaningful (change
<2 points); a slight but significant worsening was
instead visible at 1-year and 2-year follow-up.
At the end of the intervention, both groups
achieved a significant improvement (p < 0.001) also
546 Eur J Pain 20 (2016) 541--551
M. Monticone et al.
in terms of catastrophizing, but the change was clini-
cally meaningful only for the experimental group
and a significant between-group change (95% CI) of
12.4 ( 14.1; 10.7) was found after training
(Fig. 2, panel C). In the experimental group, the
baseline score remained significantly different from
both follow-ups, while no changes between baseline
and follow-ups were found in the control group.
Concerning pain and QoL, significant improve-
ments were found in both groups after training
(p < 0.001), but the experimental group improved
more and maintained all of the improvements
achieved at follow-ups. On the contrary, the control
group did not preserve the slight changes achieved
after training for some sub-scales of the SF-36 (Bod-
ily pain, Vitality, Social Function, and Emotional
Role).
Finally, a significant between-group difference was
found in terms of GPE (p < 0.001), as reported in
Table 5. The odds ratio (95% CI) of successful train-
ing (GPE score = 1–2) for the experimental versus
the control group was 35.9 (10.3; 124.9), strongly
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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).

24M p-value (F) p-value (F) p-value (F)

Group Pre-traininga Post-traininga 12M Follow-upa Follow-upa group effect time effect interaction effect

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).

12M 24M p-value (F) group p-value (F) p-value (F)

Group Pre-traininga Post-traininga follow-upa follow-upa effect time effect interaction effect

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)

SF-36, Short Form Health Survey.

a
Mean value (standard deviation).

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.

548 Eur J Pain 20 (2016) 541--551 © 2015 European Pain Federation - EFICâ
M. Monticone et al.
Figure 2 Between-group change with confidence intervals over time
for the Oswestry Disability Index (panel A), the Tampa Scale of Kinesio-
phobia (panel B) and the Pain Catastrophizing Scale (panel C).
group support and encouragement as well as for de-
centring and challenging beliefs and cognitions. Hav-
ing explained to the patients how to modify their mis-
taken fears and encouraged them to adopt appropriate
behaviours induced early positive attitudes towards
perceived disability; subjects became more comfort-
able with their usual activities after readjusting their
beliefs about the possibility of performing them
despite the pain, and this enhanced their positive atti-
tude towards the exercises and increased physical per-
formance. Satisfactory levels were maintained until
completion of a longer follow-up than previous inves-
tigated (Monticone et al., 2013, 2014), and the signifi-
cant between-group difference in disability might be
considered corresponding to the levels of catastrophiz-
ing and kinesiophobia, which improved considerably
in the experimental group yet remained unchanged in
the control group (Crombez et al., 1999).
Other group-based multidisciplinary treatments
including CBT demonstrated the importance of these
interventions in reducing disability (Brox et al.,
2003, 2006; Dufour et al., 2010; K€ a€
ap€
a et al., 2006;
Rose et al., 1997; Tavafian et al., 2011). However,
our treatment protocol, if compared with these stud-
ies, would have been defined as light/mild (i.e. 3 h
© 2015 European Pain Federation - EFICâ
Group-based training for chronic low back pain
Table 5 Analysis of the Global Perceived Effect at the end of the
intervention.
Experimental group Control group
# subjects with GPE score = 1–2 71/74 29/73
# subjects with GPE score = 3–5 3/74 44/73
Median (IQR) 1 (1) 3 (1)
p-value* <0.001
GPE score: 1 = helped a lot, 2 = helped, 3 = helped only a little,
4 = did not help, 5 = made things worse.
*Mann–Whitney U test.
per week for 5 weeks) and at risk of deterioration
over time due to a reduced time of intervention, but
the functional and psychological interventions prob-
ably represented the key factor supporting our find-
ings (Vlaeyen and Linton, 2000). Shorter
interventions could be investigated in future studies
to point out the minimum sessions required to satis-
factory deliver a rehabilitative programme including
task-oriented exercises and CBT mainly aimed at
managing the fear of movement.
Pain perception had decreased in both groups by
the end of treatment, but to a greater extent in the
experimental group. Similar trends were highlighted
during the follow-ups, suggesting the importance of
CBT in modifying pain perception effectively in
chronic populations (Van Middelkoop et al., 2011).
The perceived QoL improved in both groups by
the end of treatment, but to a greater extent in the
experimental group; changes were maintained and
for some sub-scales even further improved in the
experimental group during the follow-ups. These
improved results suggested the potential benefits of
multidisciplinary intervention in relation to physical
and mental domains.
Evaluation of the perceived global effects also
demonstrated higher levels of treatment satisfaction
in the experimental group, therefore its superiority
over a more physical approach. Implementing task-
oriented exercises, addressing patients’ fears and
engaging their attention in solving them was proba-
bly perceived by the subjects as a better answer to
their ongoing problems. This was also favoured by
the presence of a well-integrated multidisciplinary
team of physiatrists, a psychologist and physiothera-
pists, who concordantly contributed towards treat-
ment goals. However, caution is required when
interpreting these findings as the health providers
could not be blinded to the study hypothesis, and
they may have influenced the patients’ expectations
about the treatments.
This randomized clinical trial had a very high level
of internal validity as it was capable of distinguishing
Eur J Pain 20 (2016) 541--551 549
Group-based training for chronic low back pain
effects in the two groups, was adequately sized,
involved concealed randomization, blinded data col-
lection, and the effective masking of assessors and
analysts, and the baseline characteristics of the
patients were homogenous. The support of relatives
and staff helped in creating a protected environment,
limiting the drop-out rate and minimizing adverse
effects.
The sample was representative of the general pop-
ulation undergoing rehabilitation for CLBP in Italy
(Monticone et al., 2014). The subjects included were
not scoring very high on the different outcome mea-
sures such as disability, kinesiophobia, catastrophiz-
ing and pain, and our findings might not be
generalizable to more severe populations, but consid-
ered as a first-choice treatment option in subgroups
of patients with baseline scores similar to ours. Fur-
thermore, the described intervention cannot be
delivered in every rehabilitation setting as it requires
qualified staff specialized in chronic pain manage-
ment and a rehabilitation team specialized in CBT.
This study has some limitations though. First of
all, we planned the exclusive use of self-report mea-
sures, but their relationships with physical measures
or behavioural tests were not investigated. Secondly,
contact-time differences between the treatment
groups due to the psychological intervention may be
raised. Thirdly, treatment expectations were not
addressed, and this confounding factor was only par-
tially limited by telling the patients during enrol-
ment that the efficacy of both treatments had not
yet been established, and that both approaches
might contribute to improving their pain. Finally,
mood disorders such as anxiety and depression were
not investigated and we recommend that further
studies on CBT take into account a full assessment of
psychological distress.
In conclusion, our findings suggest that a multidis-
ciplinary rehabilitation of group-based task-oriented
exercises aimed at managing kinesiophobia was use-
ful in changing the course of disability, fear-avoid-
ance beliefs, catastrophizing, pain and the QoL of
subjects with CLBP. Changes were maintained for at
least 2 years after the end of the intervention. When
subjects are affected by a higher level of disability a
longer programme of training on an individual basis
might be preferred (Monticone et al., 2013).
Acknowledgement
The authors thank all of the physiotherapists and patients
who took part in the study, and Sean Gerard Nee for his
help in preparing the English version of this paper.
550 Eur J Pain 20 (2016) 541--551
M. Monticone et al.
Author contributions
M.M. was responsible for conceiving and designing the
study, interpreting the data, drafting and critically revising
the article, providing the patients, collecting and assem-
bling the data, and approving the final version of the arti-
cle. E.A. was responsible for analysing and interpreting the
data, drafting and critically revising the article, providing
statistical expertise, assembling the data and approving the
final version of the article. B.R. was responsible for con-
ceiving the experimental intervention, collecting and
assembling the data, critically revising the article and
approving the final version of the article. D.C. was respon-
sible for conceiving and designing the study, collecting the
data, critically revising the article and approving the final
version of the article. V.L. was responsible for conceiving
and designing the study, collecting the data, critically revis-
ing the article and approving the final version of the arti-
cle. C.F. was responsible for conceiving and designing the
study, interpreting the data, critically revising the article
and approving the final version of the article.
References
Apolone, G., Mosconi, P. (1998). The Italian SF-36 Health Survey:
translation, validation and norming. J Clin Epidemiol 51, 1025–1036.
Apolone, G., Mosconi, P., Ware, J. (2000). SF-36 Quality of Life
Questionnaire. User’s Manual and Guide to the Interpretation of Results (In
Italian) (Milan, Italy: Guerin & Associati).
Balagu
e, F., Mannion, A.F., Pellis
e, F., Cedraschi, C. (2012). Non-
specific low back pain. Lancet 379, 482–491.
Brox, J.I., Sørensen, R., Friis, A., Nygaard, Ø., Indahl, A., Keller, A.,
Ingebrigtsen, T., Eriksen, H.R., Holm, I., Koller, A.K., et al. (2003).
Randomized clinical trial of lumbar instrumented fusion and
cognitive intervention and exercises in patients with chronic low
back pain and disc degeneration. Spine 28, 1913–1921.
Brox, J.I., Reiker
as, O., Nygaard, Ø., Sørensen, R., Indahl, A., Holm, I.,
Keller, A., Ingebrigtsen, T., Grundnes, O., Lange, J.E., et al. (2006).
Lumbar instrumented fusion compared with cognitive intervention
and exercises in patients with chronic back pain after previous
surgery for disc herniation: a prospective randomized controlled
study. Pain 122, 145–155.
Brox, J.I., Storheim, K., Grotle, M., Tveito, T.H., Indahl, A., Eriksen,
H.R. (2008). Systematic review of back schools, brief education, and
fear-avoidance training for chronic low back pain. Spine. J Off J
North Am Spine Soc 8, 948–958.
Brox, J.I., Nygaard, Ø.P., Holm, I., Keller, A., Ingebrigtsen, T., Reikeras,
O. (2010). Four-year follow-up of surgical versus non-surgical
therapy for chronic low back pain. Ann Rheum Dis 69, 1643–1648.
Chou, R., Huffman, L.H., American Pain Society, American College of
Physicians (2007). Nonpharmacologic therapies for acute and chronic
low back pain: a review of the evidence for an American Pain
Society/American College of Physicians clinical practice guideline.
Ann Intern Med 147, 492–504.
Crombez, G., Vlaeyen, J.W., Heuts, P.H., Lysens, R. (1999). Pain-related
fear is more disabling than pain itself: evidence on the role of pain-
related fear in chronic back pain disability. Pain 80, 329–339.
Dufour, N., Thamsborg, G., Oefeldt, A., Lundsgaard, C., Stender, S.
(2010). Treatment of chronic low back pain: a randomized, clinical
trial comparing group-based multidisciplinary biopsychosocial
rehabilitation and intensive individual therapist-assisted back muscle
strengthening exercises. Spine 35, 469–476.
Fielding, S., Fayers, P., Ramsay, C.R. (2012). Analysing randomised
controlled trials with missing data: choice of approach affects
conclusions. Contemp Clin Trials 33, 461–469.
© 2015 European Pain Federation - EFICâ
M. Monticone et al.
Henschke, N., Ostelo, R.W., van Tulder, M.W., Vlaeyen, J.W., Morley,
S., Assendelft, W.J., Main, C.J. (2010). Behavioural treatment for
chronic low-back pain. Cochrane Database Syst Rev 7, CD002014.
Huskisson, E.C. (1974). Measurement of pain. Lancet 2, 1127–1131.
Jensen, I.B., Bergstr€ om, G., Ljungquist, T., Bodin, L. (2005). A 3-year
follow-up of a multidisciplinary rehabilitation programme for back
and neck pain. Pain 115, 273–283.
Johnson, R.E., Jones, G.T., Wiles, N.J., Chaddock, C., Potter, R.G.,
Roberts, C., Symmons, D.P.M., Watson, P.J., Torgerson, D.J.,
Macfarlane, G.J. (2007). Active exercise, education, and cognitive
behavioral therapy for persistent disabling low back pain: a
randomized controlled trial. Spine 32, 1578–1585.
K€a€ap€
a, E.H., Frantsi, K., Sarna, S., Malmivaara, A. (2006).
Multidisciplinary group rehabilitation versus individual physiotherapy
for chronic nonspecific low back pain: a randomized trial. Spine 31,
371–376.
Kamper, S.J., Ostelo, R.W.J.G., Knol, D.L., Maher, C.G., de Vet,
H.C.W., Hancock, M.J. (2010). Global Perceived Effect scales
provided reliable assessments of health transition in people with
musculoskeletal disorders, but ratings are strongly influenced by
current status. J Clin Epidemiol 63(760–766), e1.
Krismer, M., van Tulder, M., Low Back Pain Group of the Bone and
Joint Health Strategies for Europe Project (2007). Strategies for
prevention and management of musculoskeletal conditions. Low
back pain (non-specific). Best Pract Res Clin Rheumatol 21, 77–91.
Monticone, M., Baiardi, P., Ferrari, S., Foti, C., Mugnai, R., Pillastrini,
P., Vanti, C., Zanoli, G. (2009). Development of the Italian version of
the Oswestry Disability Index (ODI-I): A cross-cultural adaptation,
reliability, and validity study. Spine 34, 2090–2095.
Monticone, M., Giorgi, I., Baiardi, P., Barbieri, M., Rocca, B., Bonezzi,
C. (2010). Development of the Italian version of the Tampa Scale of
Kinesiophobia (TSK-I): cross-cultural adaptation, factor analysis,
reliability, and validity. Spine 35, 1241–1246.
Monticone, M., Baiardi, P., Vanti, C., Ferrari, S., Pillastrini, P., Mugnai, R.,
Foti, C. (2012a). Responsiveness of the Oswestry Disability Index and
the Roland Morris Disability Questionnaire in Italian subjects with sub-
acute and chronic low back pain. Eur. Spine J. Off. Publ. Eur. Spine
Soc. Eur. Spinal Deform. Soc Eur Sect Cerv Spine Res Soc 21, 122–129.
Monticone, M., Baiardi, P., Ferrari, S., Foti, C., Mugnai, R., Pillastrini,
P., Rocca, B., Vanti, C. (2012b). Development of the Italian version
of the Pain Catastrophising Scale (PCS-I): cross-cultural adaptation,
factor analysis, reliability, validity and sensitivity to change. Qual.
Life Res. Int J Qual Life Asp Treat Care Rehabil 21, 1045–1050.
Monticone, M., Ferrante, S., Rocca, B., Baiardi, P., Farra, F.D., Foti, C.
(2013). Effect of a long-lasting multidisciplinary program on disability
and fear-avoidance behaviors in patients with chronic low back pain:
results of a randomized controlled trial. Clin J Pain 29, 929–938.
Monticone, M., Ambrosini, E., Rocca, B., Magni, S., Brivio, F.,
Ferrante, S. (2014). A multidisciplinary rehabilitation programme
improves disability, kinesiophobia and walking ability in subjects
with chronic low back pain: results of a randomised controlled pilot
study. Eur Spine J 10, 1–9.
Morley, S. (2011). Efficacy and effectiveness of cognitive behaviour therapy
for chronic pain: Progress and some challenges. Pain 152, S99–S106.
© 2015 European Pain Federation - EFICâ
Group-based training for chronic low back pain
O’Sullivan, P.B. (2000). Lumbar segmental “instability”: clinical
presentation and specific stabilizing exercise management. Man Ther
5, 2–12.
Pincus, T., Vlaeyen, J.W.S., Kendall, N.A.S., Von Korff, M.R.,
Kalauokalani, D.A., Reis, S. (2002). Cognitive-behavioral therapy and
psychosocial factors in low back pain: directions for the future. Spine
27, E133–E138.
Rose, M.J., Reilly, J.P., Pennie, B., Bowen-Jones, K., Stanley, I.M.,
Slade, P.D. (1997). Chronic low back pain rehabilitation programs: a
study of the optimum duration of treatment and a comparison of
group and individual therapy. Spine 22, 2246–2251; discussion 2252–
2253.
Siddiqui, O., Hung, H.M.J., O’Neill, R. (2009). MMRM vs. LOCF: a
comprehensive comparison based on simulation study and 25 NDA
datasets. J Biopharm Stat 19, 227–246.
Storheim, K., Brox, J.I., Holm, I., Koller, A.K., Bø, K. (2003). Intensive
group training versus cognitive intervention in sub-acute low back
pain: short-term results of a single-blind randomized controlled trial.
J Rehabil Med 35, 132–140.
Tavafian, S.S., Jamshidi, A.R., Mohammad, K. (2011). Treatment of
chronic low back pain: a randomized clinical trial comparing
multidisciplinary group-based rehabilitation program and oral drug
treatment with oral drug treatment alone. Clin J Pain 27, 811–
818.
Van Middelkoop, M., Rubinstein, S.M., Kuijpers, T., Verhagen, A.P.,
Ostelo, R., Koes, B.W., van Tulder, M.W. (2011). A systematic review
on the effectiveness of physical and rehabilitation interventions for
chronic non-specific low back pain. Eur. Spine J. Off. Publ. Eur. Spine
Soc. Eur. Spinal Deform. Soc Eur Sect Cerv Spine Res Soc 20, 19–39.
Vibe Fersum, K., O’Sullivan, P., Skouen, J.S., Smith, A., Kv ale, A.
(2013). Efficacy of classification-based cognitive functional therapy in
patients with non-specific chronic low back pain: a randomized
controlled trial. Eur J Pain Lond Engl 17, 916–928.
Vlaeyen, J.W., Linton, S.J. (2000). Fear-avoidance and its
consequences in chronic musculoskeletal pain: a state of the art. Pain
85, 317–332.
Vlaeyen, J.W., Kole-Snijders, A.M., Boeren, R.G., van Eek, H. (1995).
Fear of movement/(re)injury in chronic low back pain and its
relation to behavioral performance. Pain 62, 363–372.
Waddell, G. (2004). The Back Pain Revolution (London: Churchill
Livingstone).
Wertli, M.M., Burgstaller, J.M., Weiser, S., Steurer, J., Kofmehl, R.,
Held, U. (2014). Influence of catastrophizing on treatment outcome
in patients with nonspecific low back pain: a systematic review. Spine
39, 263–273.
Supporting Information
Additional Supporting Information may be found in the
online version of this article at the publisher’s web-site:
Table S1. More details of study participants at baseline.
Eur J Pain 20 (2016) 541--551 551