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Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: A randomized controlled trial


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Background: Non-specific chronic low back pain disorders have been proven resistant to change, and there is still a lack of clear evidence for one specific treatment intervention being superior to another. Methods: This randomized controlled trial aimed to investigate the efficacy of a behavioural approach to management, classification-based cognitive functional therapy, compared with traditional manual therapy and exercise. Linear mixed models were used to estimate the group differences in treatment effects. Primary outcomes at 12-month follow-up were Oswestry Disability Index and pain intensity, measured with numeric rating scale. Inclusion criteria were as follows: age between 18 and 65 years, diagnosed with non-specific chronic low back pain for >3 months, localized pain from T12 to gluteal folds, provoked with postures, movement and activities. Oswestry Disability Index had to be >14% and pain intensity last 14 days >2/10. A total of 121 patients were randomized to either classification-based cognitive functional therapy group n = 62) or manual therapy and exercise group (n > = 59). Results: The classification-based cognitive functional therapy group displayed significantly superior outcomes to the manual therapy and exercise group, both statistically (p < 0.001) and clinically. For Oswestry Disability Index, the classification-based cognitive functional therapy group improved by 13.7 points, and the manual therapy and exercise group by 5.5 points. For pain intensity, the classification-based cognitive functional therapy improved by 3.2 points, and the manual therapy and exercise group by 1.5 points. Conclusions: The classification-based cognitive functional therapy produced superior outcomes for non-specific chronic low back pain compared with traditional manual therapy and exercise.
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Efficacy of classification-based cognitive functional therapy
in patients with non-specific chronic low back pain:
A randomized controlled trial
K. Vibe Fersum1, P. O’Sullivan2, J.S. Skouen1,3, A. Smith2, A. Kvåle1
1 Physiotherapy Research Group, Department of Public Health and Primary Health Care, University of Bergen, Norway
2 School of Physiotherapy, Curtin University, Bentley, Western Australia, Australia
3 The Outpatient Spine Clinic, Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Bergen, Norway
Kjartan Vibe Fersum
Funding sources
The Norwegian Fund for Post-Graduate
Training in Physiotherapy supported this
Conflict of interest
We declare no conflict of interest.
Accepted for publication
31 October 2012
Background: Non-specific chronic low back pain disorders have been
proven resistant to change, and there is still a lack of clear evidence for one
specific treatment intervention being superior to another.
Methods: This randomized controlled trial aimed to investigate the
efficacy of a behavioural approach to management, classification-based
cognitive functional therapy, compared with traditional manual therapy
and exercise. Linear mixed models were used to estimate the group
differences in treatment effects. Primary outcomes at 12-month follow-up
were Oswestry Disability Index and pain intensity, measured with numeric
rating scale. Inclusion criteria were as follows: age between 18 and 65
years, diagnosed with non-specific chronic low back pain for >3 months,
localized pain from T12 to gluteal folds, provoked with postures,
movement and activities. Oswestry Disability Index had to be >14% and
pain intensity last 14 days >2/10. A total of 121 patients were randomized
to either classification-based cognitive functional therapy group n=62) or
manual therapy and exercise group (n>=59).
Results: The classification-based cognitive functional therapy group
displayed significantly superior outcomes to the manual therapy and
exercise group, both statistically (p<0.001) and clinically. For Oswestry
Disability Index, the classification-based cognitive functional therapy
group improved by 13.7 points, and the manual therapy and exercise
group by 5.5 points. For pain intensity, the classification-based cognitive
functional therapy improved by 3.2 points, and the manual therapy and
exercise group by 1.5 points.
Conclusions: The classification-based cognitive functional therapy
produced superior outcomes for non-specific chronic low back pain
compared with traditional manual therapy and exercise.
1. Introduction
The current evidence for management of non-specific
chronic low back pain (NSCLBP) reveals that inter-
ventions such as manual therapy, exercise, acupunc-
ture, spinal injections and cognitive behavioural
therapy are not superior to each other and have a
limited long-term impact on the disorder (Assendelft
et al., 2004; Furlan et al., 2005; Hayden et al., 2005;
Ostelo et al., 2005; Staal et al., 2008).
Possible reasons for the failure of current clinical
practice to effectively manage NSCLBP are proposed to
lie in two main domains:
(1) The failure to adequately deal with NSCLBP
within a multidimensional biopsychosocial frame-
work (Borkan et al., 2002). It has been proposed that
1Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
NSCLBP represents a vicious cycle associated with dif-
ferent combinations of provocative factors. These
include cognitive factors (such as negative beliefs,
fear-avoidance behaviours, catastrophizing, hypervigi-
lance, anxiety, depression, stress, poor pacing and
maladaptive coping) (Vlaeyen and Crombez, 1999;
Linton, 2000), physical factors (pain provocative
postures and movement patterns related to altered
body schema, muscle guarding, pain behaviours and
deconditioning) (O’Sullivan et al. 2006b) and lifestyle
factors (sedentary behaviour, inactivity and sleep defi-
cits) (Bjorck-van Dijken et al., 2008).
(2) Lack of a multidimensional classification system
(MDCS) directing person-centred targeted manage-
ment for this large group of NSCLBP patients. The
Cochrane Back Review Group proposed that identifi-
cation of subgroups is a key priority of low back pain
(LBP) management in order to deal with the problem
of patient heterogeneity (Bouter et al., 2003). Recent
research supports this claim, with evidence that
NSCLBP subjects can be broadly classified based on
psychological factors (Turk, 2005; Boersma and Linton,
2006; Hill et al., 2010), movement and postural behav-
iours (Dankaerts et al., 2009), neurophysiological
factors (Smart et al., 2011) and lifestyle behaviours
[sedentary (Bjorck-van Dijken et al., 2008) vs. exces-
sive activity (Mitchell et al., 2010)]. In spite of this
knowledge, a recent systematic review concluded that
few clinical trials exist utilizing MDCS or targeted
interventions for NSCLBP (Fersum et al., 2010). The
few trials that have taken a targeted biopsychosocial
approach to the management of NSCLBP have dem-
onstrated a tendency for improved outcomes (Klaber
Moffett et al., 2004; Vollenbroek-Hutten et al., 2004;
Asenlof et al., 2005; Riipinen et al., 2005).
A novel MDCS for LBP has been developed incorpo-
rating the biopsychosocial model (O’Sullivan, 2005).
This system is integrated within the Quebec classifica-
tion system (Spitzer, 1987) and represents a multilevel
patient-centred clinical reasoning approach to broadly
classify and target management for patients with
NSCLBP. This person-centred intervention is called
classification-based ‘cognitive functional therapy’ (CB-
CFT) as it directly challenges these behaviours in a
cognitively integrated, functionally specific and gradu-
ated manner. This MDCS has good inter-tester reliabil-
ity (Dankaerts et al., 2006; Fersum et al., 2009), with a
number of studies supporting the validity of the differ-
ent subgroups on the physical domains (O’Sullivan
et al., 2006a,b; O’Sullivan and Beales, 2007a,b; Beales
et al., 2009; Dankaerts et al., 2009), as well as cogni-
tive domains (Boersma and Linton, 2006). This MDCS
has not been formally tested in a randomized con-
trolled trial (RCT) for NSCLBP disorders. Therefore, the
aim of this study was to investigate the efficacy of
CB-CFT compared with manual therapy and exercise
(MT-EX) for the management of NSCLBP. The hypoth-
esis was that a person-centred classification-based
cognitive functional approach to management of
NSCLBP disorders would be more effective than
MT-EX approach.
2. Methods
2.1 Study design
The study was a RCT designed to evaluate the efficacy
of the CB-CFT according to the system proposed by
O’Sullivan (2005), as compared with MT-EX in
patients with NSCLBP. The effects of the intervention
were assessed at 3- and 12-month follow-up. The
study received ethical approval by the regional ethics
committee of medical research in Western Norway
(REK Vest). The clinical trial’s register number is
2.2 Participants and procedures
A Norwegian university town, Bergen, with 250,000
inhabitants, provided the setting for the study. The
patients were recruited from March 2006 to June
2008 from private physiotherapy outpatient practices,
general practitioners and the outpatient spine clinic at
the Haukeland University Hospital. In addition, six
advertisements were placed in the local newspaper. All
What’s already known about this topic?
Effect sizes from randomized controlled trials uti-
lizing conservative treatment for non-specific
chronic low back pain are small.
Stratified treatment seems to be warranted and
has socio-economic impact.
For non-specific chronic low back pain, there
does not seem to be a clear consensus as to which
classification system to use.
What does this study add?
First trial for non-specific chronic low back pain
utilizing a novel multidimensional classification
system and cognitive functional approach.
Cognitive functional approach shows clinical and
statistically significant large effect sizes for
primary outcomes as well as for secondary out-
comes across multiple dimensions.
Classification-based cognitive functional therapy K. Vibe Fersum et al.
2Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
patients were presented with written information
about the study with its aims and procedures. Here, it
was clearly stated that there were two active compa-
rable treatment arms, and that based on current
knowledge, we did know which was superior. The
patients gave a written informed consent prior to pro-
ceeding to the clinical examination. The participants
were eligible for the study if they were between the
ages of 18 and 65 years, were diagnosed with NSLBP
for >3 months that was primarily localized from T12
to gluteal folds, and they reported that their pain
was provoked and relieved with postures, movement
and activities. Pain intensity measured with a pain
intensity numerical rating scale (PINRS) over the last
14 days >2/10 and an Oswestry Disability Index
(ODI) >14% was necessary to be admitted to the
The inclusion criteria of localized back pain with
mechanical behaviour to the pain were designed to
include patients whose movement behaviours had a
clear association with their pain disorder, for which
the CB-CFT intervention was designed.
The exclusion criteria were continuous sick-leave
duration for >4 months, as it was considered that
specific work-related intervention would have been
required, acute exacerbation of LBP at time of testing
in order to avoid regression to the mean, specific LBP
diagnosis (radicular pain, disc herniation, spondylolis-
thesis, stenosis, Modic changes), any low limb surgery
in the last 3 months, surgery involving the lumbar
spine, pregnancy, diagnosed psychiatric disorder,
widespread constant non-specific pain disorder, pain
without a clear mechanical behaviour, active rheuma-
tologic disease, progressive neurological disease,
serious cardiac or other internal medical condition,
malignant diseases, acute traumas, infections or acute
vascular catastrophes. A lack of compliance of greater
than 50% was set as a withdrawal criterion based on
programme compliance forms. An a priori power cal-
culation suggested that 63 patients in each group
would give 80% power to detect a group difference of
5 points in the ODI [estimating a standard deviation
(SD) of 10 points in both groups], and 1 point on the
PINRS at 1-year post-intervention (estimating an SD
of 2 points in both group).
The randomization took place at the University of
Bergen (UiB). A person independent of the study
developed a randomization schedule and produced
160 sealed opaque envelopes containing each partici-
pant’s allocation. Randomization was performed in
permuted blocks of 16. When the patients had been
examined and classified and a blinded examiner had
collected baseline data, the patient drew the envelope
containing their allocation and details of procedure in
relation to their allocation.
All subjects first underwent a comprehensive inter-
view and full physical examination at the Department
of Public Health and Primary Health Care, UiB. This
multidimensional examination was important in order
to broadly classify each subject based on his or her
pain provocative postures and movement behaviours,
lifestyle and cognitive behaviours (O’Sullivan, 2005).
During the interview, subjects were guided in ques-
tioning to inform: their history of pain, pain area and
nature, pain behaviour (aggravating/easing move-
ments and activities), their primary functional impair-
ments, disability levels, activity levels and sleep
patterns. Inquiries were also made regarding their
level of fear of pain and any avoidance of activities,
work and social engagement. Their degree of pain
focus, pain coping strategies, stress response and its
relationship to pain, and their pain beliefs were also
questioned as was any history of anxiety and depres-
sion. Finally, their beliefs and goals regarding manage-
ment of their disorder were ascertained. This
information was considered alongside the Orebro
Musculoskeletal Pain Questionnaire (OMPQ) (Linton
and Boersma, 2003) where the patient reported high
levels (>5) of stress/anxiety, depressed mood, fear of
movement and lack of pain coping strategies. These
factors were then considered within the context of the
movement behaviours and lifestyle factors, i.e., in the
context of fear, avoidance of physical activity and
specific pain provocative movement patterns were
The physical examination involved analysis of the
subject’s primary functional impairments (pain pro-
vocative postures, movements and functional tasks
reported during the interview), assessment of their
body control and awareness, as well as easing postures
and movements (O’Sullivan, 2005).
The physical examination process involved a sys-
tematic process of assessment of pain provocative pos-
tures (such as sleeping, sitting, standing and bending)
and functional movement tasks (such as sit to stand,
single-leg stand, spinal movements and lifting) and
any other specific tasks nominated by the patient as
pain provocative or that they avoided. The validity
of this clinical examination approach has been dem-
onstrated in a number of studies (O’Sullivan et al.,
2006a,b; Dankaerts et al., 2007; O’Sullivan and
Beales, 2007a,b; Beales et al., 2009; Dankaerts et al.,
2009; Sheeran et al., 2012). The reliability has pre-
viously been reported for both physical and cogni-
tive aspects based on the health-care practitioners’
ability to synthesize the patient story and clinical
K. Vibe Fersum et al. Classification-based cognitive functional therapy
3Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
examination to broadly classify the patient, based on
identification of the primary drivers of the disorder
within the different levels of the MDCS (Dankaerts
et al., 2006; Fersum et al., 2009). The examination
process follows a systematic approach (as outlined in
Supporting Information Appendix S1), but is tailored
to the patients’ presentation. In Supporting Informa-
tion Appendix S2, all the included subjects and their
subsequent classification are outlined.
The intervention took place at 3 different private
clinics and lasted for 12 weeks. Patients were
followed-up immediately and 12 months post-
intervention. After the 12-week intervention period,
participants were permitted to seek alternative care,
and the frequency and type of treatment were moni-
tored in the follow-up questionnaires. A tester blinded
to allocation, pretreatment and at 3-month follow-up
distributed the questionnaires. During the 12-month
follow-up, the questionnaires were sent by mail.
2.3 Interventions
2.3.1 CB-CFT
The behavioural management approach provided was
based on the MDCS described by O’Sullivan (2005)
and Fersum et al. (2009). Three experienced phy-
siotherapists who conducted the management had
undergone, on average, 106 hours of CB-CFT training
(including workshops, patient examinations, pilot
study and clinical manual). Depending on the differ-
ent levels of the classification system, each patient
received a specific targeted intervention directed at
changing their individual cognitive, movement and
lifestyle behaviours considered by the therapist to be
maladaptive (provocative) of their disorder. Physio-
therapists were also guided by the individuals’ OMPQ
in order to better target their management within the
psychosocial domain. The CB-CFT intervention has
four main components: (1) a cognitive component, for
each patient, their vicious cycle of pain was outlined in
a diagram based on their findings from the examina-
tion and the OMPQ; (2) specific movement exercises
designed to normalize maladaptive movement behav-
iours as directed by the movement classification; (3)
targeted functional integration of activities in their
daily life, reported to be avoided or provocative by the
patient; and (4) a physical activity programme tailored
to the movement classification (see Supporting Infor-
mation Appendix S3 for detailed description of the
CB-CFT). The initial session was 1 h and follow-ups
were 30–45 min. Patients were seen at a weekly basis
for the first two to three sessions and then progressed
to one session every 2–3 weeks during the 12-week
intervention period.
All instructions for subjects were written, and they
were asked to complete the programme on a daily
basis and complete a daily diary outlining if they had
complied with each aspect of the intervention.
2.3.2 MT-EX
Participants allocated to the comparison group were
treated with joint mobilization or manipulation tech-
niques applied to the spine or pelvis consistent with
best current manual therapy practice. These therapists
were specialists in orthopaedic manual therapy with
an average of 25.7 years of experience with no prior
training in the use of the MDCS or CB-CFT. The
particular dose and techniques were at the discre-
tion of the treating therapist, based on each partici-
pant’s examination findings. In addition, most patients
(82.5%) in this group were given exercises or a home
exercise programme. This included general exercise or
motor control exercise, but not based on the specific
MDCS as outlined by O’Sullivan (2005). The motor
control exercises involved isolated contractions of the
deep abdominal muscles in different functional posi-
tions as previously described (Richardson et al., 1998).
The therapists in this group generally spent 1 h with
the patients for the initial consultation and 30 min for
2.4. Treatment fidelity
Several strategies were applied to enhance treatment
fidelity. For every patient, a report was written, docu-
menting type of treatment, number of treatments,
medication usage before and after the intervention. In
addition, there was a therapist session-by-session
documentation of treatment content as well as indi-
vidual working sheets. The mean number of treat-
ments was 7.7 in the CB-CFT group (range 4–16; SD
2.6), and 8.0 in the MT-EX group (range 3–17; SD
2.9). All the treating physiotherapists in both treat-
ment arms prior to the intervention underwent half a
day of training with a clinical psychologist regarding
the concepts of best-practice cognitive approach to
managing back pain in order to standardize this for
both intervention arms as per clinical guidelines.
Therapy was in the primary care setting for both
groups and was pragmatic. Treatment was discontin-
ued if the therapist deemed the participant had no
further need of treatment before the 12 weeks were
completed, as is standard clinical practice. There was
Classification-based cognitive functional therapy K. Vibe Fersum et al.
4Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
no difference between the two groups in terms of
medication intake before or after the treatment.
2.5. Outcome measures
2.5.1 ODI
The primary outcome measurement for perceived
function was the ODI (Roland and Fairbank, 2000).
The ODI psychometric properties have been well
established (Fairbank and Pynsent, 2000). Studies
have shown good construct validity (Greenough,
1993; Strong et al., 1994), acceptable internal consis-
tency and test–retest reliability (Kopec et al., 1996),
and high responsiveness (Deyo and Centor, 1986).
2.5.2 Pain
Pain intensity in the previous week was another
primary outcome, measured by the PINRS (Jensen
et al., 1986). The PINRS measures pain severity by
asking the patient to select a number (from 0 to 10) to
represent how severe the pain had been over the last
2 weeks. PINRS is more reliable than the visual ana-
logue scale, especially with less educated patients
(Ferraz et al., 1990).
2.5.3 Hopkins Symptoms Checklist
Secondary outcome measures for anxiety and depres-
sion were Hopkins Symptoms Checklist (HSCL-25)
(Derogatis et al., 1974). It consists of 25 items: part I of
the HSCL-25 has 10 items for anxiety symptoms; part
II has 15 items for depression symptoms. Optimal
HSCL-25 cut-off was 1.67 for men and 1.75 for
women (Sandanger et al., 1998).
2.5.4 Fear-Avoidance Beliefs Questionnaire (FABQ)
The fear-avoidance beliefs of physical activity and
work were measured using the FABQ (Waddell et al.,
1993). The reliability and validity of this measure has
been reported previously (Kovacs et al., 2006).
2.5.5 Total lumbar spine range of motion
Total lumbar spine range of motion was measured
with the two inclinometer method (Mayer et al.,
1984) utilizing standardized protocol (Adams et al.,
1986; Bullock-Saxton, 1993; Chaory et al., 2004). The
true lumbar motion was obtained from a subtraction
of the pelvic motion from the gross motion expressed
in angular degrees of flexion and extension (Adams
et al., 1986).
2.5.6 Patient satisfaction
The patients filled out a patient satisfaction question-
naire (Ware and Davies, 1983) at 3- and 12-month
follow-up. This was just a simple questionnaire from 1
to 5 asking the patients how satisfied they were with
their treatment: 1 =satisfied, 2 =just a little satisfied,
3=neither satisfied nor dissatisfied, 4 =just a little
dissatisfied, 5 =dissatisfied.
2.5.7 Sick-leave days
In case of sick-leave days, this was extracted from the
Ørebro Screening Questionnaire using a 10-category
variable. The question asked: ‘How many days of work
have you missed because of pain during the last 18
months?’ The 10 categories were merged into 3. First
category was 0 days, second category was 1–7 days
and third category was >7 days.
2.5.8 Care-seeking
Questions regarding subsequent treatments between
the 3-month intervention period and long-term
follow-up were also assessed with a questionnaire at
12 months. The patients were asked the following
questions: (1) Have you had any treatment since the
intervention finished? Yes/No; (2) What type of treat-
ment have you had?; and (3) How many treatments
have you had?
2.6 Statistical considerations and analysis
A linear mixed model was used to estimate the group
differences in treatment effect at both time points and
also in the change in outcome from 3- and 12-month
follow-up, with baseline values included as the only
covariate. Age, gender, body mass index (BMI), LBP
duration and work status were evaluated as possible
confounders, but did not need to be included in the
final models. Bootstrapped standard errors were esti-
mated to adjust for departures from normality, as
some outcome measures displayed slightly skewed dis-
tributions. Models were examined to confirm the
absence of influential outlying observations. Statistical
significance was set at p=0.05.
Analysis was performed on an ‘available case’ basis.
Two subjects (one CB-CFT and one MT-EX) were
missing data at 3-month follow-up but provided
K. Vibe Fersum et al. Classification-based cognitive functional therapy
5Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
12-month data, and five subjects (two CB-CFT and
three MT-EX) were missing 12-month follow-up data
but provided 3-month data. These cases were included
in the model, as the linear mixed model used is a
likelihood-based estimation procedure resulting in
non-biased estimates, provided data are missing at
random. Statistically significant group differences in
sick-leave days, patient satisfaction and number of
treatments sought post-intervention were assessed
using two-sample Wilcoxon rank sum (Mann–
Whitney) test. In the case of sick-leave days, the origi-
nal variable from Ørebro Screening Questionnaire
collapsed down for tabular display but analysed using
original 10-category variable, i.e., 0, 1–2, 3–7, . . . ,
etc., days.
In addition, change in pre- to post-treatment was
estimated in both treatment groups using paired
t-tests, and the change in ODI and PINRS were calcu-
lated for each study participant, in terms of absolute
change from baseline, and tabulated with reference to
consensus values for minimally important change
(MIC) in these outcomes.
All authors had full access to the data in the study
and the corresponding author had final responsibility
to submit for publication. An independent person,
unfamiliar with the aim, groups and content of the
study, entered data into a database. Statistical analysis
was performed using Stata/IC 10.1 for Windows
(StataCorp LP, College Station, TX, USA). A secondary
independent statistician blinded to the treatment
group allocation and unfamiliar with the aim, groups
and content of the study also reviewed the statistical
3. Results
Out of the 169 patients initially enrolled, 121 patients
met the inclusion criteria and were found eligible. In
the randomized cohort, 62 patients were assigned to
the CB-CFT group, and 59 were assigned to the MT-EX
group (Fig. 1). A total of 16 of 59 (27.1%) patients
assigned to MT-EX and 11 of 62 (17.7%) patients
assigned to CB-CFT either did not start treatment or
did not complete treatment, and were unavailable for
either 3- or 12-month follow-up assessment, which
precluded an intention-to-treat analysis. Table 1 dis-
plays the baseline characteristics of these patients, by
treatment allocation.
Analysed study participants in the two treatment
arms were comparable in terms of baseline character-
istics, with the exception of small but significant dif-
ferences in HSCL and FABQ work (Table 1).
Both groups significantly improved with the
respective therapeutic interventions. After adjust-
ment for baseline scores, the CB-CFT group displayed
superior outcomes supported by both statistically and
clinically significant differences when compared with
the MT-EX group. This was evident both immediately
after and at 12-month post-intervention for both
primary and secondary outcomes (Table 2). This was
Assessed for eligibility (n=169)
Excluded (n=48)
•Not meeting inclusion criteria (n=46)
•Declined to participate (n=2)
Randomized (n=121)
Allocated to MT-EX intervention (
=59) Allocated to CB-CFT intervention (n=62)
Did not receive allocated intervention (n=8)
•Never started treatment
Discontinued intervention (n=8)
•Withdrawal without reason (n=3)
•Moved away (n=1)
•Neck fracture (n=1)
•Referred for back operation (n=1)
•Diagnosed with psoreatic arthritis
•Diagnosed with diabetes (n=1)
Did not receive allocated intervention (n=1)
•Never started treatment
Discontinued intervention (n=10)
•Withdrawal without reason (n=3)
•Time constraints (n=1)
•Moved away (n=1)
•Felt better – discontinued (n=1)
•Acute disc herniation (n=2)
•Modic changes diagnosis (n=1)
•Pregnancy (n=1)
Analysed (n=43)
Excluded from analysis (n=16)
•Never started treatment (as above) (n=8)
•Discontinued intervention (as above) (n=8)
Analysed (n=51)
Excluded from analysis (n=11)
•Never started treatment (as above) (n=1)
•Discontinued intervention (as above) (n=10)
Figure 1 Flow chart depicting participant
recruitment and final enrolment for the two
groups: manual therapy and exercise (MT-EX)
and classification-based cognitive functional
therapy (CB-CFT).
Classification-based cognitive functional therapy K. Vibe Fersum et al.
6Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
demonstrated by the degree of improvement in the
CB-CFT group for ODI score being 13.7 points [95%
confidence interval (CI): 11.4–16.1; p<0.001] and for
PINRS scores 3.2 (95% CI: 2.5–3.9; p<0.001). In the
MT-EX group, the mean improvement for ODI score
was 5.5 points (95% CI: 2.8–8.3; p<0.001) and 1.5 for
PINRS (95% CI: 0.7–2.2; p<0.001). The improve-
ments for all secondary outcomes showed similar
effects, with the CB-CFT group demonstrating signifi-
cantly greater change when compared with the
MT-EX group across all outcomes, except for total
lumbar range of motion (Table 2).
Table 3 presents the improvements in primary
outcome measures in terms of absolute improvement
from baseline. There was maintenance of treatment
effect over the 3- to 12-month follow-up time for both
groups, with no significant main effect for time or
group/time interaction identified in the linear mixed
4. Discussion
This study reveals that the CB-CFT group demonstrated
superior outcomes compared with the MT-EX group
across every domain measured at post-intervention
and at 12-month follow-up (Table 2). Both groups
showed significant improvement in short- and long-
term follow-ups; however, the CB-CFT group was
superior based on clinically meaningful changes as
defined by MIC, defined as >10-point change in ODI
and >1.5 on PINRS (Ostelo et al., 2008).
Table 1 Baseline characteristics of study participants.
Analysed (n=94)
Excluded from analysis (n=27)
(did not start or discontinued treatment)
MT-EX (n=43) CB-CFT (n=51) MT-EX (n=16) CB-CFT (n=11)
Age – mean (SD) 42.9 (12.5) 41.0 (10.3) 39.9 (13.8) 37.0 (10.5)
Female – n(%) 21 (48.8) 27 (52.9) 10 (62.5) 5 (45.5)
LBP duration – n(%)a
3–12 months 6 (14.3) 6 (11.8) 0 0
1–5 years 13 (31.0) 14 (27.5) 4 (30.8) 1 (12.5)
>5 years 23 (54.8) 31 (60.8) 9 (69.2) 7 (87.5)
Height (cm) (SD) 173.5 (8.6) 174.3 (9.4) 171.8 (10.1) 177.4 (7.9)
Weight (SD) 76.2 (13.1) 78.3 (16.6) 76.9 (16.5) 85.4 (11.9)
BMI (SD) 25.2 (3.5) 25.6 (4.0) 25.9 (4.3) 27.1 (3.1)
Work status
Paid work n(%) 34 (79.1) 45 (88.2) 15 (93.8) 11 (100.0)
Primary outcomes – mean (SD)
Oswestry Disability Index 24.0 (8.0) 21.3 (7.5) 27.9 (7.6) 23.1 (8.1)
Pain intensity last week 5.3 (1.9) 4.9 (2.0) 6.2 (1.2) 6.0 (1.9)
Secondary outcomes – mean (SD)
Hopkins Symptoms Checklist 1.57 (0.39) 1.40 (0.33) 1.78 (0.53) 1.60 (0.42)
Fear-avoidance physical 11.8 (5.0) 11.1 (3.9) 12.6 (4.6) 10.9 (5.3)
Fear-avoidance work 19.3 (11.1) 14.1 (9.6) 17.8 (8.2) 13.5 8.7
Sick-leave days – n(%)
None 13 (30.2) 15 (29.4) 2 (12.5) 3 (27.3)
1–7 days 9 (20.9) 13 (25.5) 4 (25.0) 2 (18.2)
>7 days 21 (48.9) 23 (45.1) 10 (62.5) 6 (54.5)
Lumbar ROM – mean (SD) 46.2 (13.0) 50.2 (14.9) 44.3 (13.6) 57.6 (9.8)
Disability: Oswestry Disability Index (0–100), low scores indicate low disability.
Pain: intensity last week (pain intensity numerical rating scale 0–10), low scores indicate low pain intensity.
Anxiety/depression: Hopkins Symptoms Checklist – 25-item checklist – low scores indicate low anxiety and depression.
Fear of movement/(re) injury: The Fear-Avoidance Beliefs – Physical (0–24), low scores indicate low fear related to physical activities.
Fear of movement/(re) injury: The Fear-Avoidance Beliefs – Work (0–42), low scores indicate low fear related to work activities.
Range of motion: Lumbar motion was obtained from a subtraction of the pelvic motion from the grossmotion expressed in angular degrees of flexion and
BMI, body mass index; CB-CFT, classification-based cognitive functional therapy; LBP, low back pain; MT-EX, manual therapy and exercise; ROM, range of
motion; SD, standard deviation.
aMissing four cases from MT-EX and three from CB-CFT group.
K. Vibe Fersum et al. Classification-based cognitive functional therapy
7Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
Table 2 Outcomes (unadjusted means and SDs).
Mean SD Mean SD Mean difference (95 % CI)
Primary outcome variables
Oswestry Disability Index Questionnaire
Baseline 24.0 8.0 21.3 7.5
3 months 18.5 8.1 7.6 6.7 -9.7 (-12.7 to -6.7)***
12 months 19.7 11.7 9.9 9.8 -8.2 (-12.6 to -3.8)***
Pain intensity in last week
Baseline 5.3 1.9 4.9 2.0
3 months 3.8 1.9 1.7 1.7 -2.1 (-2.7 to -1.4)***
12 months 3.8 2.1 2.3 2.0 -1.3 (-2.1 to -0.5)***
Secondary outcome variables
Hopkins Symptoms Checklist
Baseline 1.56 0.39 1.40 0.33
3 months 1.43 0.37 1.20 0.27 -0.12 (-0.19 to -0.04)**
12 months 1.51 0.47 1.22 0.32 -0.13 (-0.22 to -0.04)**
Fear-avoidance physical
Baseline 11.8 5.0 11.1 3.9
3 months 10.3 6.0 6.1 5.0 -3.6 (-5.3 to -1.9)***
12 months 10.9 5.5 5.8 5.5 -4.7 (-6.5 to -3.0)***
Fear-avoidance work
Baseline 19.1 11.1 14.1 9.6
3 months 17.4 10.8 8.3 8.4 -5.7 (-7.8 to -3.6)***
12 months 16.6 12.2 7.7 9.0 -5.6 (-8.7 to -2.5)***
Total lumbar spine range of motion
Baseline (degrees) 46.2 13.0 50.2 14.9
3 months 45.6 12.7 49.7 14.0 1.9 (-2.8 to 6.7)
Sick-leave days [n(%)]
0 1–7 >7 0 1–7 >7
Baseline 14 (31.8) 9 (20.5) 21 (47.7) 15 (29.4) 13 (25.5) 23 (45.1)
12 months 16 (40.0) 7 (17.5) 17 (42.5) 32 (65.3) 7 (14.3) 10 (20.4) z=2.95**
Patient satisfactionb[n(%)]
1 2 3 451 2345
3 months328 (68.3) 6 (14.6) 5 (12.2) 0 2 (5.9) 48 (94.1) 1 (2.0) 2 (3.9) 0 0 z=3.21**
12 months318 (46.2) 8 (20.5) 9 (23.1) 3 (7.7) 1 (2.5) 46 (95.8) 1 (2.1) 1 (2.1) 0 0 z=5.18***
Care-seeking after intervention [n(SD) ] MT-EX CB-CFT
12 months 10.6 (13.3) 2.1 (5.4) z=4.79***
Disability: Oswestry Disability Index (0–100), low scores indicate low disability.
Pain: intensity last week (pain intensity numerical rating scale 0–10), low scores indicate low pain intensity.
Anxiety/depression: Hopkins Symptoms Checklist – 25-item checklist – low scores indicate low anxiety and depression.
Fear of movement/(re) injury: The Fear-Avoidance Beliefs – Physical (0–24), low scores indicate low fear related to physical activities.
Fear of movement/(re) injury: The Fear-Avoidance Beliefs – Work (0–42), low scores indicate low fear related to work activities.
Range of motion: Lumbar motion was obtained from a subtraction of the pelvic motion from the grossmotion expressed in angular degrees of flexion and
CB-CFT, classification-based cognitive functional therapy; MT-EX, manual therapy and exercise; SD, standard deviation.
aNegative values favour CB-CFT.
bPatient satisfaction: (1–5), 1 = completely satisfied,2=alittle bit satisfied, 3 = neither satisfied or dissatisfied,4=alittle bit dissatisfied, 5 = completely
Classification-based cognitive functional therapy K. Vibe Fersum et al.
8Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
The effect sizes of conservative interventions
from previous Cochrane reviews reveal findings
similar to the MT-EX group (Assendelft et al., 2004).
In response, calls have been made for a paradigm shift,
away from a biomedical ‘injury’ model, to viewing
LBP as a multifactorial biopsychosocial disorder, and
directing treatment at beliefs and behaviours that
promote pain and disability rather than simply at the
signs and symptoms associated with the disorder. Calls
have also been made for the need for a multidimen-
sional classification-based approach to direct manage-
ment of NSCLBP in order to make treatment more
person-centred (Borkan et al., 2002; O’Sullivan,
2011). This is supported by reports that disability
levels in chronic pain are better predicted by cognitive
and behavioural aspects of pain rather than sensory
and biomedical ones (Campell and Edwards, 2009).
CB-CFT addresses all of these objectives.
Although satisfaction rates were high in both groups,
odds of being completely satisfied were over three
times higher in the CB-CFT group at 3 months and five
times higher at 12 months. The degree of patient satis-
faction is seen as a reflection of the quality of care and
as an important outcome in its own right (May, 2001).
The importance of communication, patient-centred
approaches and goal matching has been well docu-
mented in the literature as important for the therapeu-
tic relationship, enhancing compliance and patient
outcomes (Linton, 2005; O’Sullivan, 2011).
CB-CFT had a strong cognitive focus with an
emphasis on reframing the persons’ understanding of
their back pain in a person-centred manner, with an
emphasis on changing maladaptive movement, cogni-
tive and lifestyle behaviours contributing to their
vicious cycle of pain. This was performed by means of
reflective communication, providing a contemporary
understanding of pain mechanisms, correcting faulty
pathoanatomical beliefs, goal setting, verbal, written
and visual feedback (viewing their own back) and a
strong emphasis on normalizing movement behav-
iours within a graded functional approach.
Although this is the first RCT to address maladaptive
movement behaviours specific to the patient’s presen-
tation within a cognitive framework, the exact ben-
efits from targeting specific movement training cannot
be isolated from the other aspects of the intervention.
The behaviours that were targeted were prioritized
based on the movements or postures that patients
reported that they most feared, avoided and/or that
provoked them. These identified movements were the
targets for the movement retraining aspect of the
intervention based on the patient’s classification and
were integrated to the goals of the patient. The use of
visual feedback such as mirrors was central to this
process. The aim of this approach was for each subject
to acquire self-management strategies for their disor-
der by developing positive back pain beliefs, pain
control, developing adaptive strategies of movement
that enhanced functional capacity and the ability to
engage in regular physical activity.
These findings are supported by previous reports
of benefits with different targeted behavioural
approaches to managing NSCLBP. Moseley et al.
(2004) reported reduced pain and enhanced function
associated with pain education. Asenlof et al. (2009)
reported superior long-term outcomes for treating
NSCLBP with an individually tailored behavioural
intervention targeting cognitions, motor behaviour
and activity, compared with physical therapy. The use
of visual feedback when training movement in
patients with LBP has also been shown to reduce pain
and influence functional capacity (Sheeran et al.,
2012; Wand et al., 2012). Hill et al. (2011) reported
superior outcomes when management was targeted
on the basis of psychosocial risk factors. Vlaeyen et al.
(2002) reported benefits with a graded exposure
approach to management in a series of NSCLBP
patients with high levels of fear. CB-CFT incorporates
all of these aspects within its intervention.
Given the multidimensional nature of the CB-CFT
intervention, it is not clear as to the exact basis for
the superior outcomes. We hypothesize that the
Table 3 Immediate and long-term improvements in primary outcome
measures from baseline [n(%)].
3 months 12 months
No change 14 33.3 2 4.0 12 30.8 5 10.2
<10 points 14 33.3 12 24.0 15 38.5 13 26.5
10–19 points 12 28.6 23 46.0 9 23.1 24 49.0
20–29 points 1 2.4 11 22.0 2 5.1 5 10.2
30 or more points 1 2.4 2 4.0 1 2.5 2 4.1
Pain (PINRS)
0 15 35.7 6 12.0 12 30.8 10 20.4
1 point 8 19.1 6 12.0 11 28.2 3 6.1
2 points 7 16.7 9 18.0 7 17.9 14 28.6
3 points 4 9.5 8 16.0 4 10.3 7 14.3
4–5 points 4 9.5 13 26.0 3 7.7 7 14.3
>6 points 4 9.5 8 16.0 2 5.1 8 16.3
Minimally important change: Clinically meaningful changes are defined as
>10-point change in Oswestry Disability Index and >1.5 on PINRS (Ostelo
et al., 2008). CB-CFT, classification-based cognitive functional therapy;
MT-EX, manual therapy and exercise; PINRS, pain intensity numerical
rating scale.
K. Vibe Fersum et al. Classification-based cognitive functional therapy
9Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
mechanisms for change are likely to be multifactorial
given the patient-centred body–mind behavioural
approach, in contrast to a more treatment-orientated
signs and symptoms approach in manual therapy. On
one hand, this behavioural approach may have
impacted on cognitive factors known to affect pain
sensitivity and disability such as developing positive
beliefs, reduced fear, increased awareness, enhanced
understanding and control of pain, adaptive coping,
enhanced self-efficacy, confidence and improved
mood. Evidence for this is supported by the reduction
in fear of movement and improved mood observed
following the intervention. On the other hand, the
functional behavioural aspects of the intervention
were targeted at enhancing body awareness, relax-
ation of guarded muscles, normalizing maladaptive
movement patterns, body schema retraining with the
use of mirror feedback, extinguishing pain behav-
iours, conditioning and increased functional capacity.
These factors have been associated with levels of
pain, disability, fear and catastrophizing (Wideman
et al., 2009; Lewis et al., 2012; Wand et al., 2012).
We also acknowledge that the active engagement
required of subjects for this behavioural approach
may present a barrier for those unwilling to self-
manage their disorder (Carr et al., 2006). This may be
dependent on the levels of acceptance and readiness
to engage in behavioural change, although these
factors were not formally assessed.
Although it was not a primary aim of the CB-CFT
intervention, the results demonstrate a 2.95-times less
likelihood of taking sick leave for their LBP at 12
months compared with the MT-EX group. Previously,
only studies using cognitive behavioural therapy in
multidisciplinary treatment models have shown an
effect on sick-listing for this patient group (Airaksinen
et al., 2006). However, as these numbers were
extracted from the OMPQ and were self-reported,
these findings must be interpreted with some caution.
The patients in the CB-CFT group also sought less
additional treatment for their pain, implying they may
have been more empowered to self-manage their dis-
order, suggesting significant cost–benefits.
A limitation of this study was the number of
patients that either did not start or complete treat-
ment. While there was a comparable proportion of
non-completers in each group (Table 2), 8 of 59
(13.5%) of the MT-EX group failed to commence their
allocated treatment, compared with only 1 of 62
(1.6%) of the CB-CFT group. This may be due to the
fact that seven of these subjects had reported previous
manual therapy treatment with poor effect, which
would have potentially biased for a poorer outcome in
the MT-EX group. It should be noted that there was no
statistically significant difference between completers
and non-completer based on baseline characteristics,
and as we performed our analysis conditioning on
baseline scores and confirmed the absence of a con-
founding effect of age, gender, BMI, LBP duration and
work status on our results, we are confident that our
estimates of treatment effect are not substantially
biased by these missing cases. Also of note, no drop-
outs reported adverse effects from either intervention
arm. Furthermore, due to a lack of power, we were
unable to determine the influence of the subject
classification on the outcome.
We acknowledge that there are also a number of
additional methodological considerations that may
have influenced the results of this study. Firstly, the
patients were recruited from a variety of sources both
primary and secondary care levels, as well as newspa-
per advertising, which could have influenced the kind
of patients who entered the study. However, the wide
inclusion criteria in the study suggest that a common
and representative group of patients with chronic
localized LBP without objective sign of pathology to
the spine were included. Webb et al. (2003) reported
that an Oswestry score of >25% is considered the
cut-off score for classifying ‘disabling back pain’. The
patients recruited were, on average, just below this
[24.0 (MT-EX) and 21.3 (CB-CFT)] at baseline, and
hence it can be said that the patients sampled in this
study had moderate back pain and functional impair-
ment sufficient to result in activity limitation and sick
leave for many (see Table 1). It is also acknowledged
that therapists in both arms of the study were not
blinded to the intervention, and although all thera-
pists had considerable experience, the influence of
therapist enthusiasm and expectation for change was
not controlled for.
Furthermore, the multidimensional nature of the
study limits any conclusion as to the specific effects of
the different components of the intervention. Future
research that investigates matching versus non-
matching of interventions for patients with chronic
mechanical LBP may help identify the effects of spe-
cific aspects of the intervention (Kent et al., 2010).
Also given this was a pragmatic trial, the intervention
dose was not controlled in either group, although both
groups received remarkably similar attention. While
this intervention appears to be successful for the popu-
lation we tested, further studies are needed to inves-
tigate those with higher levels of pain and disability,
patients that are long-term sick-listed as well as in
other cultural and occupational groups, in order to
determine the generalizability of the findings. This
Classification-based cognitive functional therapy K. Vibe Fersum et al.
10 Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
approach also needs to be compared with other cog-
nitive approaches and tested within a multi-centre
trial framework in the future.
4.1 Conclusions
The results of this study support that a behaviourally
orientated targeted approach to manage NSCLBP
(CB-CFT) was more effective at reducing pain, disabil-
ity, fear beliefs, mood and sick leave at long-term
follow-up than MT-EX.
Research fellow Fersum was supported by the Norwegian
Fund for Post-Graduate Training in Physiotherapy.
Many thanks to the treating therapist in both treatment
arms AB, RH, NE, EØ and LGL.
Author contributions
K.V.F., P.O., J.S.S. and A.K. were all involved in the planning
of the RCT, preparing protocols, ethical approval and decid-
ing the interventions utilized. A.S. was involved in the sta-
tistical methods used in the manuscript. K.V.F., P.O., J.S.S,
A.S. and A.K. were all involved in the writing and editing the
manuscript. All authors discussed the results and com-
mented on the manuscript.
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Supporting Information
Additional Supporting Information may be found in the
online version of this article:
Appendix S1. Displays an overview of the multidimen-
sional classification system. This system is guided by a clinical
reasoning process that considers the presence and domi-
nance of different factors, allowing for patient-centred tar-
geted intervention.
Appendix S2. Displays an overview of the randomized
subjects (n=121) and how they spread out in the different
Appendix S3. Schematic overview of the four different
components of the CB-CFT treatment.
K. Vibe Fersum et al. Classification-based cognitive functional therapy
13Eur J Pain •• (2012) ••–•• © 2012 European Federation of International Association for the Study of Pain Chapters
... However, this difference did not remain significant in the multivariable analysis, suggesting there are other more important factors influencing the referral to treatment in SHC. No difference in psychological distress between groups may also indicate a biopsychosocial approach with cognitive therapy among PTs (31). As expected, the patients in SHC reported more pain. ...
... As expected, the patients in SHC reported more pain. This is comparable to previous findings in clinical trials in Norway (12,(31)(32)(33). Despite statistically significant, pain is moderate in both groups in the current study, and the difference is probably not clinically relevant (34,35). ...
... Even though moderate disability was reported both in PHC and SHC, the difference between the 2 groups, is considered clinically relevant (34). The levels of disability are also comparable to previous findings (31,32,37)). However, the results changed in the multivariable analyses. ...
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Objective: To describe and compare patients with neck and back pain treated by physiotherapists in primary healthcare (PHC) and in departments for physical medicine and rehabilitation in specialist healthcare (SHC) in Norway. Design: Cross-sectional study using data from the FYSIOPRIM database in PHC and the Norwegian Neck and Back Registry in SHC. Neck and back pain patients in the period 2014–18 aged ≥ 18 years were included. Demographics, lifestyle and clinical factors were investigated. Results: A total of 8,125 patients were included: 584 in PHC and 7,541 in SHC. Mean age was 47.1 and 45.5 years, respectively, with more females in PHC (72% vs 56%). Low levels of education and physical activity, high workload and receiving social benefits were associated with treatment in SHC. Treatment in SHC was most common from 3 to 12 months’ pain duration. Higher pain intensity and lower health-related quality of life were found in patients treated in SHC, no differences were found for psychological distress. Conclusion: This is the first study comparing register data in patients with neck and back pain treated in PHC and SHC. Differences were found in pain and health-related quality of life, but levels of psychological distress were similar between patients treated in PHC and those treated in SHC.
... nine (42.9%), and 11 studies (52.4%) were scored negatively respectively (see Table 3 summary). Of 11 studies with a zero rating for statistical power (item 27), five were underpowered [36,40,42,46,48], whilst it was unclear/undetermined for the remaining six [35,41,[50][51][52][53]. By implication, the between-group results may be understated, since four of 15 comparative studies (3 RCTs and 1 CCT) [35,41,42,48] reporting non-significant differences between groups were Studies included in synthesis (n = 21) Global estimates for LBP were extrapolated to create a rudimentary set of criteria to assess external validity (item 11) and uniformly applied to each study's sample. ...
... LBP is typically more common in females, but these differences appear to diminish once chronicity is accounted for [56] whilst age-related LBP prevalence is generally negatively skewed and reported to be highest between 40 to 69 years [4] whilst global LBP prevalence reportedly peaks around 80 years old [57]. Accordingly, nine studies [36,38,41,44,46,47,50,52,54] scored '1' for satisfying both conditions: (i) the proportion of females is higher but less than 60% overall; and (ii) the mean/ median age falls within the range of 40.00 to 63.5 years (but 10 and 17 studies satisfied one condition respectively -see Additional file 1: Item 11 scoring grid Results S1). Since comorbid and/or confounding conditions (e.g., age restrictions, pregnancy, neurological, rheumatological, cancer, fractures, recent surgery) were generally excluded, these samples are fairly homogenous since their inclusion-exclusion criteria were comparable, but older patients were typically excluded. ...
... Twenty-one studies (N = 3075 participants) with a wide range of research designs were included in the review; specifically, 12 randomised clinical trials (RCTs; n = 1064 [35][36][37][38][39][40][42][43][44][45][46]; n = 255 cluster-randomised [41]), three non-randomised, controlled clinical trials (CCTs; n = 460) [47][48][49], four observational cohort studies (n = 1220) [52][53][54][55], one case series (n = 50) [51], and one interrupted time series (n = 26) [50]. RCT sample sizes ranged from 38 (pilot [42]) to 222 (3-armed trial [44]) patients. ...
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Background and objective Chronic low back pain is pervasive, societally impactful, and current treatments only provide moderate relief. Exploring whether therapeutic elements, either unrecognised or perceived as implicit within clinical encounters, are acknowledged and deliberately targeted may improve treatment efficacy. Contextual factors (specifically, patient’s and practitioner’s beliefs/characteristics; patient-practitioner relationships; the therapeutic setting/environment; and treatment characteristics) could be important, but there is limited evidence regarding their influence. This research aims to review the impact of interventions modifying contextual factors during conservative care on patient’s pain and physical functioning. Databases and data treatment Four electronic databases (Medline, CINAHL, PsycINFO and AMED) were searched from 2009 until 15th February 2022, using tailored search strategies, and resulted in 3476 unique citations. After initial screening, 170 full-text records were potentially eligible and assessed against the inclusion–exclusion criteria. Thereafter, studies were assessed for methodological quality using a modified Downs and Black scale, data extracted, and synthesised using a narrative approach. Results Twenty-one primary studies ( N = 3075 participants), were included in this review. Eight studies reported significant improvements in pain intensity, and seven in physical functioning, in favour of the contextual factor intervention(s). Notable contextual factors included: addressing maladaptive illness beliefs; verbal suggestions to influence symptom change expectations; visual or physical cues to suggest pain-relieving treatment properties; and positive communication such as empathy to enhance the therapeutic alliance. Conclusion This review identified influential contextual factors which may augment conservative chronic low back pain care. The heterogeneity of interventions suggests modifying more than one contextual factor may be more impactful on patients’ clinical outcomes, although these findings require judicious interpretation.
... The clinical journey is adapted to the individual's profile following three main components: (i) making sense of pain, (ii) exposure with control and (iii) lifestyle changes [25]. Vibe Fersum et al. [30,31] found that CFT was significantly more effective than the combination of manual therapy and exercise for chronic low back pain, and that the reduction in disability was maintained three years after the beginning of the study. This study had significant methodological shortcomings regarding the failure to carry out the intention to treat analysis, high risk of attrition bias and random error [9,11]. ...
... The last participant`s data was collected on seeking treatment for low back pain with at least 12 weeks duration and were able to speak and understand Portuguese. Following Vibe Fersum et al.[30] and O'Keeffe et al.[21] criteria, a score greater than 14% on Oswestry Disability Index (ODI) was required for inclusion. Participants were excluded if the primary pain area was not the lumbar spine (from T12 to buttocks); if leg pain was the primary problem (e.g., nerve root compression or disc prolapse with true radicular pain/radiculopathy, lateral recess or central spinal stenosis); if the patient underwent invasive pain relieving procedures such as injection-based therapy (e.g., epidurals) and day case procedures (e.g., rhizotomy) in International Association for the Study of Pain. ...
Cognitive functional therapy (CFT) is a physiotherapy-led intervention which has evolved from an integration of foundational behavioral psychology and neuroscience within the physiotherapist practice directed at the multidimensional nature of chronic low back pain (CLBP). The current evidence about the comparative effectiveness of CFT for CLBP is still scarce. We aimed to investigate whether CFT is more effective than core training exercise and manual therapy (CORE-MT) in pain and disability in patients with CLBP. A total of 148 adults with CLBP were randomly assigned to receive five one-hour individualised sessions of either CFT (n = 74) or CORE-MT (n = 74) within a period of 8 weeks. Primary outcomes were pain intensity (numeric pain rating scale, 0-10) and disability (Oswestry Disability Index, 0-100) at 8 weeks. Patients were assessed pre-intervention, at 8 weeks, 6 and 12 months after the first treatment session. Altogether, 97.3% (n=72) of patients in each intervention group completed the 8 weeks of the trial. CFT was more effective than CORE-MT in disability at 8 weeks (MD= -4.75; 95% CI -8.38 to -1.11; p=0.011, effect size= 0.55), but not in pain intensity (MD= -0.04; 95% CI -0.79 to 0.71; p=0.916). Treatment with CFT reduced disability, but the difference was not clinically important compared with CORE-MT post-intervention (short term) in patients with CLBP. There was no difference in pain intensity between interventions, and the treatment effect was not maintained in the mid-term and long-term follow-ups.
... Saper et al. founded that yoga and PT are effective for CLBP after 12-week intervention, and yoga is not inferior to PT in terms of improving lumbar function and relieving pain (Saper et al., 2017). Vibe et al. compared the effects of cognitive function therapy with those of PT for CLBP and showed that PT fully reflects the emphasis on exercise therapy and the importance of classified diagnosis and treatment (Vibe Fersum et al., 2013). Pengel et al. used physiotherapist-directed exercise interventions in patients with LBP, and their pain and physical function scores were significantly better than those of the placebo group after 6 weeks (Pengel et al., 2007). ...
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Objectives Chronic low back pain has become a major cause of global disability and caused a huge economic burden to society. Physical therapy is a vital strategy for rehabilitation of chronic low back pain. Although several trials have shown that Tai Chi Quan is a beneficial treatment, the comparative effectiveness of Tai Chi Quan versus physical therapy is unknown. We are conducting a randomized controlled trial to assess the effectiveness of Tai Chi Quan versus that of physical therapy in treating chronic low back pain.Methods We will perform a single-blind randomized controlled trial on elderly people with chronic low back pain. 138 participants will be randomly assigned to the Tai Chi Quan group (60-min classes, three times per week for 12 weeks) or physical therapy group (10 min of evaluation and warm-up, 40 min of therapist-directed exercise therapy, and 10 min of relaxation, three times per week for 12 weeks) with an allocation of 1:1. The participants will be followed up for 40 weeks for the study of long-term effects. The primary outcomes include pain intensity and back-related function at 12 weeks. Secondary outcomes include lumbar quantitative sensory testing, balance, cognitive function, psychosocial function, cost-effectiveness, compliance and adverse events. We will perform the intention-to-treat analysis for withdrawal and missing data.DiscussionThe study will be the first randomized trial with comparative-effectiveness of Tai Chi Quan and physical therapy for chronic low back pain. Standardized protocol, large sample size, and comprehensive outcomes are important features in this trial. This study aims to determine the feasibility and effectiveness of Tai Chi Quan for low back pain. The results of this study will be beneficial for elderly people with low back pain and medical rehabilitation personnel.Clinical Trial, identifier ChiCTR2000029723.
... Lately, plenty of studies were published that strongly suggested the beneficial effect that cognitive-behavioral treatment (CBT) approaches have on managing CLBP. [8][9][10][11] Meticulously enough, mere wording itself has the ability to affect clinical outcomes either negatively or positively in musculoskeletal rehabilitation. 12 Still, no clear CBT pattern exists for LBP patients. ...
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Low back pain (LBP) is a common clinical problem imposing a prominent socio-economic burden. The purpose of this systematic review was to investigate the biopsychosocial effects of the Mulligan Concept (MC) of manual therapy (MT) when applied to patient's with LBP. Three researchers independently evaluated the literature quality, and completed a review on five online databases (Medline, Cochrane Library, Science Direct, ProQuest and Google Scholar) for articles published from January 1st 2010 to November 20th 2021, using a combination of free words, Wildcards and Medical Subject Headings (MESH) terms: " Mulligan mobilization " AND " back pain " OR " SNAGs." In total, 62 studies were selected for full-text reading, from which finally 6 studies were included in the present review. The results revealed that the studies where the MC of MT was applied to treat LBP mainly lacked concern regarding the effect that the intervention has on the cognitive and behavioural parameters. The ones that introduced measure outcomes for at least some parts of the cognitive behavioural components, showed that the MC has a positive effect, even though without a long-term follow-up assessment. This review summarized that the evidence of the MC on cognitive behavioural (CB) aspects of patients with LBP is controversial and scarce.
... Therefore, healthcare professionals should evaluate and minimize their patients' fear-avoidance behaviors. Given that psychological interventions (e.g., cognitive-behavior therapy) are significantly better than routine treatment (83), back-care advice (84) or exercises (85,86) in reducing fear-avoidance beliefs in patients with LBP, healthcare professionals should be either trained to deliver behavioral psychological interventions (87) or refer indicated patients to psychologists for proper management. ...
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Introduction: Lumbar multifidus muscle (LMM) dysfunction is thought to be related to pain and/or disability in people with chronic low back pain (CLBP). Although psychosocial factors play a major role in pain/disability, they are seldom considered as confounders in analyzing the association between LMM and CLBP. Objectives: This study aimed to determine: (1) differences in psychological factors, insomnia, and LMM characteristics between people with and without CLBP; (2) associations between psychological factors, insomnia, or LMM characteristics and low back pain (LBP) intensity or LBP-related disability in people with CLBP; and (3) whether LMM characteristics are related to LBP symptoms in people with CLBP after considering confounders. Methods: Seventy-eight volunteers with CLBP and 73 without CLBP provided sociodemographic information, filled the 11-point numeric pain rating scale and Roland-Morris disability questionnaire (RMDQ). They completed the Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), Fear Avoidance Belief Questionnaire (FAB), and Insomnia Severity Index Scale (ISI). Resting and contracted thickness of LMM at L4-S1 levels were measured from brightness-mode ultrasound images. Percent thickness changes of LMM at L4-S1 levels during contraction were calculated. Resting LMM stiffness at L4-S1 was measured by shear wave elastography. Associations among LMM, psychosocial or insomnia parameters and clinical outcomes were analyzed by univariate and multivariate analyses. Results: People with CLBP demonstrated significantly higher LBP-intensity, RMDQ, HADS, FAB, PCS, and ISI scores than asymptomatic controls (p < 0.05). The former also had significantly smaller percent thickness changes of LMM at L4/L5 during contraction. LBP-intensity was positively related to scores of PCS-total, PCS-helplessness, FAB-total, FAB-work, and ISI in people with CLBP (p < 0.05). RMDQ scores were positively associated with the scores of HADS-total, HADS-depression, PCS-total, FAB-total, FAB-physical activity, PCS-helplessness, and ISI in people with CLBP (p < 0.05). FAB-work and ISI scores together explained 24% of LBP-intensity. FAB-total scores alone explained 34% of variance of LBP-related disability in people with CLBP. Conclusion: More fear-avoidance belief or insomnia is related to greater LBP-intensity and/or LBP-related disability in people with CLBP. Although people with CLBP were thought to have aberrant LMM morphometry/function, no LMM characteristics were related to LBP-intensity or LBP-related disability after considering other confounders.
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Background Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy (CFT) is a promising new intervention that deals with potentially modifiable multidimensional aspects of pain (e.g., provocative cognitive, movement, and lifestyle behaviors). Methods To investigate the efficacy of CFT compared with a sham intervention for pain intensity and disability post-intervention (immediately after the last session) in patients with non-specific chronic low back pain (CLBP). This study is a randomized controlled trial in which 152 (18–60 years old) patients with CLBP will be enrolled. The patients will be randomly allocated to receive (1) CFT intervention or (2) sham intervention. The experimental group will receive individualized CFT in a pragmatic manner (5 to 7 sessions) based on the clinical progression of the participants. The sham group will attend six sessions: consisting of 30 min of photobiomodulation using a detuned device and more than 15 min of talking about neutral topics. Patients from both groups also will receive an educational booklet (for ethical reasons). Participants will be assessed pre and post-intervention, 3 months, and 6 months after randomization. The primary outcomes will be pain intensity and disability post-intervention. The secondary outcomes will be: pain intensity and disability at 3- and 6-month follow-up, as well as self-efficacy, global perceived effect of improvement, and functioning post-intervention, 3-, and 6-month follow-up. The patients and the assessor will be blinded to the treatment administered (active vs. sham). Statistical analysis The between-group differences (effects of treatment), as well as the treatment effect for the primary and secondary outcomes, and their respective 95% confidence intervals will be calculated by constructing linear mixed models. Discussion To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes. Trial registration NCT04518891 . First Posted: August 19, 2020.
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Background To apply the Bio-Psych-Social (BPS) model into clinical practice, it is important not to focus on psychosocial domains only since biomedical factors can also contribute to chronic pain conditions. The cognitive functional therapy (CFT) is the management system based on the BPS model for chronic nonspecific low back pain (CNSLBP). Objectives This study aimed to compare CFT with the other interventions for CNSLBP regarding pain, disability/functional status, QoL and psychological factors. Design This study was a systematic review and meta-analysis of a randomised controlled trial. Method Literature Search was conducted in electronic search engines. Enrolled participants included 1) CNSLBP and 2) primary, secondary, or tertiary care patients. CFT was the interventions included. Comparisons were any types of treatment. Results Three studies met the eligibility criteria. The total number of participants was 336. For pain intensity, MD [95% CIs] was -1.38 [-2.78 − 0.02] and -1.01 [-1.92 − -0.10] at intermediate and long term for two studies, respectively. About disability/functional status, SMD [95% CIs] was -0.76 [-1.46 − -0.07] at the intermediate for three studies and MD [95% CIs] was -8.48 [-11.47 − -5.49] at long term for two studies. About fear of physical activity, MD [95% CIs] was -3.01 [-5.14 − -0.88] and -3.56 [-6.43 − -0.68] at intermediate and long term for two studies, respectively. No studies reported scores associated with QOL. All the quality of the evidence was very low. Conclusions Three studies were included and the quality of all the evidence was very low. Although the study found statistically significant differences in some measures, the effectiveness of the CFT will need to be re-evaluated in the future. Trial registration PROSPERO registration number CRD42020158182 .
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Annotation Non-Specific Back Pain (NSBP) is very common. Data from the international literature tell us about a high rate of almost 80% of addresses, being caused by chronic back pain, among them being non-specific back pain (8). The question is, if we can help patients of this type, through physiotherapy and Combination Manual Therapy, to improve the patient's physical condition and reduce the level of pain in each patient, in the study conducted on the basis of the Medical Physical Recovery Center of the Professional Association of Physiotherapists and Manual Therapists "Medkinetica" Chisinau. We will analyze the possibilities of the PRQ Questionnaire, if it is possible to dynamically quantify the process of physical recovery through the combination of Physical Therapy and Manual Therapy for patients with NSBP. Hypothesis We set out to conduct a study in which to assess the physical condition and dynamics of the physical condition of patients suffering from non-specific back pain. To evaluate the results obtained from the recovery program performed. The study should focus on the realization of a program of individual procedures, performed daily-consecutively, up to one hour each procedure, based on Physical Therapy and Manual Therapy combined (n = 10). In order to elucidate, evaluate and dynamically compare the condition of patients, as well as to monitor the level of pain, we chose to use the Application Questionnaire-individualized, specially developed for patients suffering from back pain-"POTAPENCO ROMAN QUESTIONNAIR" (PRQ) ®. We voluntarily proposed this questionnaire to the patients to complete it before and after the recovery treatment course, after which we would describe the accumulated information graphically in order to be able to quantify the patients' condition, in dynamics. The novelty brought to the scientific literature in the field The Physical Recovery Program, based on Physical Therapy and Manual Therapy combined, has proven to be very effective. In the international literature there is a very small number of studies dedicated to this issue. It is also a small number of Open Access information to get acquainted with the results of these recovery programs. The study allows a better understanding of the physical condition of patients suffering from non-specific back pain. We leave all the information received from the study and from the PRQ Questionnaire to be open, so that everyone can examine, research and repeat it (if necessary an independent study) for veracity and to compare the results obtained. The questionnaire demonstrated its effectiveness and importance in the process of quantifying and assessing the physical condition of patients with back pain, including those with non-specific back pain. Physical Therapy and Manual Therapy confirm and demonstrate their importance and effectiveness in the physiorehabilitation process of patients suffering from back pain.
Objective: To study the long-term outcomes of two interventions targeting patients with sub-acute and persistent pain in a primary care physiotherapy setting. Design: A 10-year follow-up of a two-armed randomised controlled trial, initially including 97 participants. Interventions: Tailored behavioural medicine treatment, applied in a physiotherapy context (experimental condition), and exercise-based physiotherapy (control condition). Main measures: Pain-related disability was the primary outcome. The maximum pain intensity, pain control, fear of movement, sickness-related absence (register data) and perceived benefit and confidence in coping with future pain problems were the secondary outcomes. Results: Forty-three (44%) participants responded to the follow-up survey, 20 in the tailored behavioural medicine treatment group and 23 in the exercise-based physiotherapy group. The groups did not differ in terms of the change in the scores for the primary outcome (p=0.17) of pain-related disability between the experimental group (median: 2.5, Q1-Q3: -2.5-14.25), and the control group (median: 0, Q1-Q3: -5-6). Further, there were also no significant differences found for the secondary outcomes except for sickness-related absence, where the exercise-based physiotherapy group had more days of sickness-related absence three months before treatment (p= 0.02), and at the 10-year follow-up (p=0.03). Discussion: The beneficial effects favouring tailored behavioural medicine treatment that observed post-treatment and at the two-year follow-up were not maintained 10 years after treatment.
The measurement of subjective pain intensity continues to be important to both researchers and clinicians. Although several scales are currently used to assess the intensity construct, it remains unclear which of these provides the most precise, replicable, and predictively valid measure. Five criteria for judging intensity scales have been considered in previous research: ease of administration of scoring; relative rates of incorrect responding; sensitivity as defined by the number of available response categories; sensitivity as defined by statistical power; and the magnitude of the relationship between each scale and a linear combination of pain intensity indices. In order to judge commonly used pain intensity measures, 75 chronic pain patients were asked to rate 4 kinds of pain (present, least, most, and average) using 6 scales. The utility and validity of the scales was judged using the criteria listed above. The results indicate that, for the present sample, the scales yield similar results in terms of the number of subjects who respond correctly to them and their predictive validity. However, when considering the remaining 3 criteria, the 101-point numerical rating scale appears to be the most practical index.
This paper introduces readers to certain aspects of satisfaction. It reviews the reasons why patient satisfaction is important as an outcome, even though there is continuing debate about what exactly satisfaction represents. The best way to obtain information on what patients consider important is through the use of qualitative study designs. Previous research has found that significant dimensions of satisfaction relate to outcome, organisational issues, and interaction with health professionals. The key dimensions specific to back pain patietns relate to information provision, empathy, and promoting self-care.
Study Design. Review of advances in the primary care research on low back pain (LBP) from a unique international forum, and analysis of open-ended questionnaires from participants. Summary of Background Data. LBP continues to be one of the most common and challenging problems in primary care. It is associated with enormous costs in terms of direct health care expenditures, and indirect work and disability-related losses. Objective. To ascertain the current status and state of the art regarding LBP in primary care. Methods. Four reviewers independently assessed the content and implications of presentations at the Fourth International Forum for Primary Care Research on LBP, pooled the data, and then augmented it with open-ended questionnaires completed by 35 participants. Results. The Fourth Forum documented the field’s emergent new paradigm–a transition from thinking about back pain as a biomedical “injury” to viewing LBP as a multifactorial biopsychosocial pain syndrome. The paradigm shift has occurred in the context of increased interest in evidence-based medicine regarding LBP in primary care. The Forum demonstrated the strides taken in moving from research and evidence gathering, through guidelines and policy formulations and finally to the dissemination and implementation imperative. There was an increasing confidence among the Forum researchers that LBP can be managed successfully in primary care settings through a combination of encouraging activity, reassurance, short-term symptom control, and alteration of inappropriate beliefs about the correlations of back pain with impairment and disability. There is also recognition that a wide range of international, evidence-based guidelines now exists that have very similar messages. Conclusions. The Fourth Forum reflected a major shift in the conceptualization of LBP in primary care and an increased emphasis on implementation and dissemination of LBP research findings and clinical guidelines. Although there is a wide array of challenges ahead, the Fourth Forum provided a clear message regarding the need to focus research energies on changing practitioner behavior.
Interpretation of any postural changes over time relies on the knowledge that the person's perception of comfortable erect posture remains sufficiently constant. This study measured the repeatability of sagittal spinal alignment during one day, and the degree of variability in that alignment measured subsequently four, eight and 12 days, and 16 and 24 months later. Normal women, pregnant women and women with low back pain, in the age range of 15 to 34 years, were included in the study. Spinal curvature was determined using a clinometer, while an electro-goniometer attached to callipers determined the degree of pelvic tilt. Results demonstrated that on any one day, a consistent postural alignment is assumed (in terms of spinal curvature and pelvic inclination) when an individual is asked to stand comfortably erect. In addition, in the normal, symptom-free, young adult subject, the perception of posture, and therefore postural alignment remains constant for at least two years.
A technique for measuring the curvature of the lumbar spine is described and evaluated. Two small electronic inclinometers are attached to the skin overlying the spinous processes of L1 and S1. The signal from these inclinometers is stored and then processed to give a record of lumbar curvature against time. Tests showed that recordings from the inclinometers were reproducible and correlated well (r=0.91) with flexion angles measured from X-rays. The dynamic response of the system was good enough to measure lumbar curvature during typical bending and lifting movements.