Manual Therapy 15 (2010) 382e387

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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
Article history: Received 14 July 2009 Received in revised form 22 February 2010 Accepted 2 March 2010 Keywords: Low back pain Education Exercise Randomised controlled trial

a b s t r a c t
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.

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.

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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

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

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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. EDEX (n 20) Gender Age Height Weight BMI Duration of pain 14F 6M 45.2 (11.9) 1.66 (0.09) 79.2 (15.1) 28.7 (5.6) 7.6 (7.0) ED (n 18) 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) 0.4 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)

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

0.92 0.10 0.70 0.11 0.04

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.

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) 28.1 (20.4) 39.3 (26.2)

5.6 (3.9) 3.3 (3.0) 23.9 (23.3) 8.4 (7.5)

6.4 (5.1) 4.3 (4.2) 19.1 (18.9) 22.6 (30.8)

2.152

0.127

3.975

0.025*

25.8 (7.4) 28.4 (8.2) 50.0 (11.4) 41.9 (12.5) 11.42 (3.82) 9.79 (2.56) 390.2 (89.8) 439.1 (86.6) 8284 (3725) 8001 (2071)

21.9 (8.2) 21.3 (6.5) 48.8 (12.2) 55.1 (4.7) 10.76 (2.76) 9.00 (1.68) 433.9 (81.42) 490.6 (85.1) 8927 (3932) 9166 (2774)

21.5 (7.5) 23.7 (6.6) 49.5 (13.1) 49.5 (9.8)

0.440

0.646

4.011

0.024*

0.009

0.924

0.037

0.848

0.111

0.740

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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

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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. References
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