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Pain biology education and exercise classes

compared to pain biology education alone for
individuals with chronic low back pain: A pilot
randomised controlled trial
Article in Manual therapy March 2010
DOI: 10.1016/j.math.2010.03.003 Source: PubMed

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Manual Therapy 15 (2010) 382e387

Contents lists available at ScienceDirect

Manual Therapy
journal homepage: www.elsevier.com/math

Original article

Pain biology education and exercise classes compared to pain biology education
alone for individuals with chronic low back pain: A pilot randomised
controlled trial
Cormac G. Ryan*, Heather G. Gray, Mary Newton, Malcolm H. Granat
School of Health, Glasgow Caledonian University, Scotland G4 0BA, UK

a r t i c l e i n f o

a b s t r a c t

Article history:
Received 14 July 2009
Received in revised form
22 February 2010
Accepted 2 March 2010

The aim of this single-blind pilot RCT was to investigate the effect of pain biology education and group
exercise classes compared to pain biology education alone for individuals with chronic low back pain
(CLBP). Participants with CLBP were randomised to a pain biology education and group exercise classes
group (EDEX) [n 20] or a pain biology education only group (ED) [n 18]. The primary outcome was
pain (0e100 numerical rating scale), and self-reported function assessed using the Roland Morris
Disability Questionnaire, measured at pre-intervention, post-intervention and three month follow up.
Secondary outcome measures were pain self-efcacy, pain related fear, physical performance testing and
free-living activity monitoring. Using a linear mixed model analysis, there was a statistically signicant
interaction effect between time and intervention for both pain (F[2,49] 3.975, p < 0.05) and pain selfefcacy (F[2,51] 4.011, p < 0.05) with more favourable results for the ED group. The effects levelled off
at the three month follow up point. In the short term, pain biology education alone was more effective
for pain and pain self-efcacy than a combination of pain biology education and group exercise classes.
This pilot study highlights the need to investigate the combined effects of different interventions.
2010 Elsevier Ltd. All rights reserved.

Keywords:
Low back pain
Education
Exercise
Randomised controlled trial

1. Introduction
Chronic low back pain (CLBP) is a complex condition for which
many different interventions exists. A number of different treatments have been shown to be effective including; education, exercise, manual therapy, multidisciplinary and cognitive behavioural
interventions (Hilde and Bo, 1998; Abenhaim et al., 2000; Tugwell,
2001; Guzman et al., 2002; Moffett and Mannion, 2005; Waddell
and Burton, 2005; Airaksinen et al., 2006). Clinical management of
patients with CLBP often comprises of two or more different
management strategies delivered simultaneously. This can occur
without evidence that the two management strategies have
a synergistic effect. The interaction effects of different management
strategies need to be further investigated so that appropriate
combinations of interventions can be delivered for each patient.
Group, aerobic based, exercise classes are a common management strategy for individuals with CLBP. A number of randomised
controlled trials have found such classes to be benecial for this
patient group (Frost et al., 1995, 1998; Moffett et al., 1999; Klaber

* Corresponding author. Tel.: 44 141 331 3327; fax: 44 141 331 8112.
E-mail address: cormac.ryan@gcal.ac.uk (C.G. Ryan).
1356-689X/$ e see front matter 2010 Elsevier Ltd. All rights reserved.
doi:10.1016/j.math.2010.03.003

Moffett et al., 2004; UK BEAM Trial Team, 2004). The exact mechanisms by which group exercise classes bring about a therapeutic
effect are not fully understood. It may be that psychosocial, rather
than physical, mechanisms bring about the effect considering that
as few as four to ve classes can bring about a therapeutic effect
despite this being an insufcient training stimulus to bring about
physiological training effects (Klaber Moffett et al., 2004).
Pain biology education is a relatively new intervention for the
management of CLBP. It is a cognitive behavioural based intervention which attempts to reduce pain and disability by explaining the
biology of the pain to the patient (Butler and Moseley, 2003). This
type of education has been shown to be superior to more
biomedical forms of education for this patient group (Moseley et al.,
2004). Pain biology education has also been found to be useful
when delivered in combination with usual care physiotherapy
(Moseley, 2002).
Considering both pain biology education and group exercise
classes attempt to decrease fear of harm and increase physical
activity (PA) in a paced manner it is logical to suggest that both
interventions delivered together would have an added benet to
one another. However, the combined effect of these interventions has not been investigated. Such work is required to guide
clinical practise.

C.G. Ryan et al. / Manual Therapy 15 (2010) 382e387

The aim of this study was to provide pilot data investigating

the combined effect of pain biology education and group exercise
classes compared to pain biology education alone for individuals
with CLBP. The primary outcome measures were self-reported
pain and function. Secondary outcome measures were pain
related fear, pain self-efcacy, physical performance testing and
free-living physical activity (PA) monitoring.
2. Methods
2.1. Participants
All patients who met the inclusion/exclusion criteria were
provided with the opportunity to opt into the study. The inclusion
criteria were: 18e65 years, non-specic low back pain >3 months
duration and no history of surgery. The exclusion criteria were;
physiotherapy within the past three months, involvement in
regular sports activities twice per week for the past six months,
constant or persistent pain adjudged clinically to be due to nerve
root irritation, fractures, non-back related musculoskeletal problems which may affect ability to participate in the exercise classes,
women who are or have been pregnant in the past year, and
a positive response to red ag questions indicating a more serious
pathology such as malignancy. Recruitment occurred between
September-2005 and January-2007.
This study received ethical approval from the Greater Glasgow
National Health Service and the Glasgow Caledonian University,
School of Health and Social Care, research and ethics committees.
Written informed consent was obtained from all participants.
2.2. Experimental protocol
In this single-blinded RCT, participants were recruited from ve
different physiotherapy departments and randomised using
a random number generator to the education only group (ED) or
the education and exercise group (EDEX). At baseline, a set of selfreport outcome measures were collected, three physical performance tests were completed and free-living step count was
recorded. Demographic characteristics were also collected. All
patients then participated in a two and a half hour session of pain
biology education. Those in the ED group received no further
intervention while those in the EDEX group were invited to take
part in six exercise classes over an eight week period. Eight weeks
later, the post treatment assessment was performed, and all
outcome measures were collected. Three months later a postal
follow up was performed and the self-report outcome measures
were collected. The therapist delivering the education session and
collecting the outcome measures was blinded to treatment allocation. Blinding allocation was concealed using sealed envelopes
and allocation patients were not allocated until after the education
had been received.
2.3. Interventions
The pain biology education used in this study was based upon
that developed by Butler and Moseley (2003). The education
session was delivered as a one off, two and a half hour cognitive
behavioural intervention focused on reshaping the participant's
beliefs and attitudes about their back pain, attempting to decrease
fear avoidance and harm beliefs, increase self-efcacy, and decrease
avoidance behaviour. This was achieved by providing information
on the biology of pain. The education was delivered using verbal
communication, prepared diagrams and free-hand drawings. This
form of intervention can decrease pain, pain related fear and
behaviour, and increase self-reported function when provided

383

alone or in conjunction with usual care physiotherapy (Moseley,

2002, 2004, 2005; Moseley et al., 2004). Additionally, all participants received The Back Book, a booklet which has been shown to
be benecial for individuals with CLBP (Burton et al., 1999).
The exercise classes used in this study are known within the UK
as the Back to Fitness exercise classes (Moffett and Frost, 2000).
These exercise classes were ongoing within the Greater Glasgow
National Health Service (NHS) at the time the study was being
undertaken, and participants randomised to the exercise group
joined in with NHS patients. Each individual was invited to attend
six classes, one a week for six weeks. The classes involved circuit
based, graded, aerobic exercise with some core stability exercises.
Three different exercise sites were used, involving different
instructors. As the classes were organised and delivered by the
NHS, making this a pragmatic RCT, it was not practical to change the
classes so that each site performed identical exercises. However all
three classes were similar and heavily based upon the guidelines
outlined in the literature (Moffett and Frost, 2000). The classes
involved a warm-up phase (10 min), an aerobic phase (20e30 min),
and a warm-down phase (10e15 min). The aerobic phase involved
circuit based exercise. For most exercises there was an easy,
moderate, and hard version, and the participant could choose
which version to perform. Participants were encouraged to work at
an intensity considered somewhat hard for them.
2.4. Primary outcome measures
Self-reported functional ability was assessed using the Roland
Morris Disability Questionnaire (RMDQ). The RMDQ consists of 24
dichotomous items, is widely used in the literature and has demonstrated validity, reliability, and responsiveness to change (Roland and
Fairbank, 2000; Peat, 2004). A change of 4 or more points was
considered clinically important (Roland and Fairbank, 2000).
Pain was assessed using a numerical rating scale (NRS) going
from 0 to 100 rated upon pain experienced on the day of assessment. The scale was anchored using the following terms 0 no
pain and 100 pain as bad as it could be. The pain NRS has been
shown to be a valid measure of pain demonstrating convergent
validity (r 0.65e0.88, p < 0.001) with other pain assessment tools
(Jensen et al., 1986; Von Korff et al., 2000).
2.5. Secondary outcome measures
Physical performance was assessed using the repeated sit-tostand test, the fty-foot walk test and the 5-min walk test
(Simmonds et al., 1998). During the repeated sit-to-stand test the
participant was required to sit-to-stand ve times from a standard
chair. The shorter the time taken to complete the better the performance. The fty-foot walk test required the participant to walk
a distance of fty feet. The shorter the time taken to complete the
task the better the performance. The 5-min walk test required the
participant to walk as far as a possible in a period of 5 min between
two markers 30 m apart. The three tests have demonstrated validity
and reliability as performance measures (Simmonds et al., 1998).
Pain related fear was assessed using the Tampa Scale of Kinesiophobia-13 (TSK-13). The TSKe13 is a modied version of the
original Tampa Scale of Kinesiophobia. The questionnaire consists
of 13 items, on a four point scale. Higher scores indicate greater
levels of pain related fear. The TSK-13 has demonstrated a good
level of internal consistency in a CLBP population (Cronbach's alpha
0.82) (Goubert et al., 2004).
Pain self-efcacy, which was assessed using the pain self-efcacy questionnaire (PSEQ) (Nicholas, 1989), is a measure of an
individual's belief that they can carry out activities and functions
despite their pain (Nicholas et al., 1992). The questionnaire contains

384

C.G. Ryan et al. / Manual Therapy 15 (2010) 382e387

10 items (0e6 scale) where participants are asked to rate how

condent they are that they can perform a certain activity. The
higher the score the greater the individuals pain self-efcacy. The
questionnaire has demonstrated a high level of internal consistency
(Cronbach's alpha 0.92), and a test-retest reliability of r 0.73
(p < 0.001), for this patient group (Nicholas, 2007).
Objectively measured free-living PA has been shown to be
a useful outcome measure for individuals with musculoskeletal
conditions (Bussmann and Stam, 1998; Walker et al., 1998, 1999).
Step-count was measured over a one week period using the
activPAL activity monitor (PAL Technologies Ltd; Glasgow, Scotland). The activPAL has been shown to be a valid monitor for
measuring free-living PA in healthy adults (Grant et al., 2006; Ryan
et al., 2006; Godfrey et al., 2007) and individuals with CLBP (Ryan
et al., 2008).
2.6. Data analysis
An a-priori sample size calculation using the pain outcome
results of Frost et al., (1995) estimated that 41 participants would be
required in both groups to identify an effect size of 0.63 with an
alpha level of 0.05 and a power of 80%. This was used to guide
participant recruitment numbers. A post hoc power calculation was
also performed to inform a future large scale trial based upon the
primary outcome measures. Power calculations were carried out
using the statistical package G*Power 3 (Faul et al., 2007).
Those allocated to a specic group at the beginning of the study
were in the same group at the end of the study, regardless of their
behaviour during the study (e.g. those randomised to the EDEX
group were analysed as part of the EDEX group even if they did not
attend any exercise classes).
Data were analysed using SPSS (version 16.0) and a signicance
level was set at p  0.05. The normality of the data was assessed
using the One-Sample KolmogoroveSmirnov test. All data was
found to me normally distributed. Comparisons between group
characteristics (age, height, weight, BMI and pain duration) were
made using unpaired t-tests. The intervention effects were assessed
using a linear mixed model analysis (interaction between time and

intervention group) which accounted for any differences in baseline values within participants and accounted for missing data. This
model considered repeated measures over three time periods and
two groups entered as xed factors. Additionally, the crossover
effect of group and time period was entered as an interaction term.
Within the model duration of pain was entered as a covariate to
account for differences between groups for this participant characteristic at baseline. This was the only signicantly different
characteristic between groups.
3. Results
3.1. Participants
Seventy individuals expressed an interest in taking part in this
study. The participant pathway is shown in Fig. 1. Twenty-ve
individuals initially agreed to be contacted by the researcher but
then decided not to participate in the study for the following
reasons; insufcient time, failed to opt in, not interested, no reason
given. Seven individuals consented to take part but on initial
assessment did not meet the inclusion/exclusion criteria. The
participant characteristics for the 38 individuals who provided
a full set of baseline data are presented in Table 1. There was no
signicant difference between the EDEX group and the ED group
for any of the participant characteristics except for pain duration
which was signicantly longer in the ED group.
A further seven individuals dropped out before the post treatment free-living PA data could be collected. Reasons for dropping
out at this point included insufcient time, family commitments,
one lady became pregnant and another broke her ankle, One male
participant could not be contacted. At the 3 month assessment 27
participants completed the study and 11 did not. Non-completers
were signicantly younger than completers (47.8  9.4 yrs vs.
39.3  11.8 yrs, 95% CI 15.8 to 1.2, p < 0.05). There was no
signicant difference between completers and non-completers for
gender, height, weight, BMI, duration of pain or employment status.
Exercise class attendance ranged from 0 to 6 sessions. Of the 20
participants randomised to the EDEX group, two dropped-out

Fig. 1. The gure shows the participant pathway. F females, EDEX Education and exercise group, ED Education only group.

C.G. Ryan et al. / Manual Therapy 15 (2010) 382e387

Table 1
Participant Characteristics This table shows the participant characteristics of the two
groups who provided baseline data. Data are presented as mean (SD) and group
comparisons were performed using student independent t-tests.

Gender
Age
Height
Weight
BMI
Duration of pain

EDEX
(n 20)

ED
(n 18)

14F 6M
45.2 (11.9)
1.66 (0.09)
79.2 (15.1)
28.7 (5.6)
7.6 (7.0)

11F 7M
45.5 (9.5)
1.72 (0.12)
77.5 (10.7)
26.2 (3.5)
13.7 (10.2)

p-value

Mean diff
(95% CI)

0.92
0.10
0.70
0.11
0.04

0.4
0.06
1.7
2.5
6.1

(7.5 to 6.8)
(0.13 to 0.01)
(7.0 to 10.4)
(0.6 to 5.6)
(11.8 to 0.4)

prior to beginning the exercise classes. Of the 18 who provided

post treatment data, three attended zero classes and six attended
six classes. The median attendance was 4.5 classes, and the mode
6.0 classes. Twelve (60%) of the participants attended at least half
of the classes.
3.2. Primary outcome measures
The mean (SD) data for the two primary outcome measures are
presented in Table 2 and in Figs. 2 and 3. There was a statistically
signicant interaction effect between time and group intervention
for pain with more favourable results for the ED group (F
[2,49] 3.975, p < 0.05) (Fig. 3). There was a similar non-signicant
trend for a more favourable functional outcome in the ED group (F
[2,51] 2.152, p 0.127) (Fig. 2). The effect for pain and function
levelled off at the three month follow-up point.
3.3. Secondary outcome measures
The mean (SD) data for the secondary outcome measures are
presented Table 2. There was a statistically signicant interaction
effect between time and group intervention for pain self-efcacy
with more favourable results for the ED group (F[2,51] 4.011,
p < 0.05). The effect for pain self-efcacy levelled off at the three
month follow-up point.
There was no statistically signicant effect for the remaining
secondary outcome measures.

385

4. Discussion
The aim of this study was to provide pilot data investigating the
combined effect of pain biology education and group exercise
classes compared to pain biology education alone for individuals
with CLBP. The ndings suggest that for pain and pain self-efcacy,
in the short term, the education only intervention had a greater
effect than the education and exercise group.
Frost et al. (1995) performed an RCT similar in design to the
current study, where one group received an education session and
one group received education as well as group exercise classes.
Frost et al. reported signicantly greater improvement in the
combined education and exercise group. In the Frost et al. study the
education was based on the medical model of back pain and
included information on anatomy, biomechanics and posture. The
pain biology education session used in the current study was
a cognitive behavioural intervention based on the biopsychosocial
model of back pain attempting to educate patients on the biology of
pain aiming to decrease fear and distress, and encourage a return to
usual daily activity (Butler and Moseley, 2003). Previous research
has directly compared these two forms of education and found pain
biology education to be superior and has suggested that
a biomedical back education may actually have a negative effect on
patient outcome (Moseley et al., 2004). Thus, in the study by Frost
et al., (1995) the back to tness classes may have shown added
benet to the education session because of the lack of effect, or
indeed negative effect of such a biomedical education.
It is unclear as to why the education only group had better short
term outcomes in this study. However there are a number of
possible explanations. Among other things, the purpose of the
education session was to demedicalise the person's condition,
shift attitudes towards a more biopsychosocial self-management
approach, and highlight that hurt does not equal harm. Attending
the exercise classes in a clinical setting with a clinical class
instructor (physiotherapist) may have detracted from that message
and reinforced the concept of the participants being patients, with
something medically/structurally wrong, requiring medical treatment. It may have reinforced the individual's perception of themselves as a patient, the patient persona. The minimally invasive
single cognitive behavioural education session may have

Table 2
Group comparisons. Data are presented as mean (SD). * Signicant at p  0.05. F and p-values were calculated using a mixed model analysis.
Pre
Primary outcome measures
Function (0e24)
Exercise & Education
Education
Pain (0e100)
Exercise & Education
Education
Secondary outcome measures
Pain related fear (13e52)
Exercise & Education
Education
Pain self-efcacy (0e60)
Exercise & Education
Education
50 ft walk (sec)
Exercise & Education
Education
5 min walk (m)
Exercise & Education
Education
Free-living step count (steps)
Exercise & Education
Education

Post

FU

F-value

p-value

9.4 (4.2)
10.8 (5.2)

5.6 (3.9)
3.3 (3.0)

6.4 (5.1)
4.3 (4.2)

2.152

0.127

28.1 (20.4)
39.3 (26.2)

23.9 (23.3)
8.4 (7.5)

19.1 (18.9)
22.6 (30.8)

3.975

0.025*

25.8 (7.4)
28.4 (8.2)

21.9 (8.2)
21.3 (6.5)

21.5 (7.5)
23.7 (6.6)

0.440

0.646

50.0 (11.4)
41.9 (12.5)

48.8 (12.2)
55.1 (4.7)

49.5 (13.1)
49.5 (9.8)

4.011

0.024*

11.42 (3.82)
9.79 (2.56)

10.76 (2.76)
9.00 (1.68)

0.009

0.924

390.2 (89.8)
439.1 (86.6)

433.9 (81.42)
490.6 (85.1)

0.037

0.848

8284 (3725)
8001 (2071)

8927 (3932)
9166 (2774)

0.111

0.740

386

C.G. Ryan et al. / Manual Therapy 15 (2010) 382e387

Fig. 2. The Function scores for both groups, pre-intervention, post-intervention and at
the three month follow up stage. Data are presented as mean (SD). RMDQ Roland
Morris Disability Questionnaire.

contributed to a speedier exit from the person's patient-persona

state, resulting in a faster improvement in outcome.
The EDEX group had increased therapistepatient interaction. As
a result, patients may have attributed improvements to the therapist and not themselves, decreasing feelings of accomplishment
and self-efcacy, which may have undermined the education
(Dolce, 1987; Klaber Moffett and Richardson, 1997). There is some
evidence that attending such a class may inadvertently reinforce
any negative pre-existing beliefs, either through the therapists use
of language and terminology or through certain behaviours and
interactions (Morris, 2004). This may have been even more of an
issue if the therapist providing the classes had beliefs and attitudes
deeply rooted in the biomedical model subscribing to a more
structural-pathology understanding of the condition, which they
may have been passed onto the participants in their class. This may
have diluted many of the messages put forward in the pain biology
education. There is a growing body of evidence that the attitudes
and beliefs of the therapist affect the information they provide their
patients (Rainville et al., 2000; Linton et al., 2002). However, the
attitudes and beliefs of the therapists delivering the exercise classes
were not assessed in this study.
Participants randomised to the EDEX group participated in
exercise classes which were also attended by low back pain patients
who were not participating in this study. It is possible that this may
have had an effect on the outcomes for the EDEX patients. For
example, the non-participant patients are unlikely to have had the
same level of pain biology education, and indeed may have

possessed a strong structural pathological view point of pain which

they may have communicated to the participants in this study
attending the same exercise class. This interaction may have diluted
the message provided in the pain biology lecture and may partially
explain the superior outcomes for the ED group.
Greater improvement in the ED group may have been associated
with mixed information in the EDEX group. Providing two sets of
information, using different amounts and formats of information
can lead to poorer outcomes than using one set of information
alone (Little et al., 2001). The information and advice provided by
the therapists who supervised the exercise classes was not
controlled and was left to the physiotherapists' professional
judgement. This was done to create a realistic NHS based back to
tness exercise class environment. It is likely that the information/
advice differed somewhat from the information provided in the
pain biology education session. This may have led to confusion, and
even frustration, on the part of the patient, which could have had
a negative impact on patient improvement.
This pilot study had a number of strengths, including randomised
assignment and investigator blinding. The study had three types of
outcome measure, self-report, PPT and objectively measured freeliving activity. The agreement in ndings between the different types
of outcome measure increases the condence in the results. The study
also had a number of weaknesses; the study was not double blinded,
participants knew to which group they had been allocated. This may
have resulted in a placebo effect, although it could be argued that any
placebo affect would have produced better outcomes in the EDEX
group. The sample size in this study was small, increasing the likelihood of a type II error. Based upon the three month follow up data
a power calculation, based upon a simple t-test, has shown that for
80% power at an alpha level of 0.05, a sample size of 66 participants
would be needed in each group to detect a signicant difference in
pain levels and 162 participants in each group to detect a signicant
difference in self-reported function.
The study would have beneted from a group-exercise-classonly group, to better understand if the poorer outcomes in the
EDEX group were due to the interaction between pain biology
education and exercise or if it was due to the exercise alone. While
participants were requested not to seek co-interventions beyond
their GP during the course of the study, one participant from the ED
group reported that she received osteopathic manipulations. None
of the remaining participants reported receiving co-interventions.
Finally, three of the participants attended no exercise classes and
only six attended all six classes, the results of this study may have
been considerably different if all participants had attended all six
classes. However this was a pragmatic trial and articially enforcing
full attendance would have reduced the generalisability of the
results. Other studies which have investigated the efcacy of the
back to tness exercise classes have had similar issues with
attendance (UK BEAM Trial Team, 2004).
5. Conclusion
In conclusion, pain biology education was more effective for
pain, and pain self-efcacy than a combination of pain biology
education and group exercise classes, for individuals with CLBP, in
the short term. The rationale for this nding is not fully understood.
This pilot study highlights the need to investigate the combined
effects of different interventions, as it cannot be assumed that
a synergistic effect will occur, and a negative interaction is possible.
Acknowledgements

Fig. 3. The pain scores for both groups, pre-intervention, post-intervention and at
the three month follow up stage. Data are presented as mean (SD). NRS numerical
rating scale.

This study was funded by the School of Health and Social Care of
Glasgow Caledonian University, and no nancial support was

C.G. Ryan et al. / Manual Therapy 15 (2010) 382e387

received from any commercial company. One of the authors is a coinventor of the activPAL physical activity monitor and a director of
PAL technologies Ltd. The remaining authors declare no competing
interests. The authors would like to acknowledge the signicant
statistical input of Dr. Sebastien Chastin and Dr. Jon Godwin of Glasgow Caledonian University.
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