Patient perceptions of physical therapy within a trial for back pain treatments (UK BEAM) [ISRCTN32683578]

Abstract

Objectives. To explore the views of participants in a randomized controlled trial of physical treatments for low back pain about the treatment packages they received in the trial.

Methods. Within a randomized controlled trial that found small to moderate benefits from adding a manipulation package or an exercise programme to general practice care, we elicited participants’ views on the treatment using an open question in participant questionnaires. These data were analysed using an adapted framework approach.

Results. We received a total of 1259 comments from 1334 participants. Participants randomized to usual general practice care reported dissatisfaction with receiving only ‘usual care’, which consisted of providing analgesic medication without providing an explanation for their pain. Those randomized to a manipulation package felt the intervention was appropriate to their needs and commonly reported striking benefits. Participants assigned to the exercise programme developed a sense of self-reliance in managing back pain, although some failed to be sufficiently motivated to continue their exercise regimen outside the classes.

Conclusions. This qualitative analysis has found much clearer differences between the groups than the main quantitative analysis. This suggests that some of the added value from being allocated to additional physical treatment for low back pain is not being captured by existing methods of measurement. Improved methods of assessment that consider a wider range of domains may be needed when interpreting the added value of such treatments to individual patients.

Health services researchers are increasingly gaining an understanding of how the process of implementing clinical interventions in randomized controlled trials informs their interpretation [1, 2]. These processes may be particularly important when interpreting the results of randomized controlled trials of physical treatments for musculoskeletal disorders, such as low back pain, which may at best produce small effect sizes [3–5]. These small effect sizes contrast with the popularity of such treatments with patients and the high rates of satisfaction with osteopathy [6] and the dissatisfaction with general practitioners found in some empirical studies [7]. A review of existing community studies of patients’ and practitioners’ beliefs and expectations suggests that there may be some tensions between the expectations of patients and their treating practitioners around diagnostic and treatment models used by the two groups [S. Parsons, A. Breen, N. Foster, G. Harding, T. Pincus, S. Vogel, M. Underwood, submitted for publication].

An example of such a trial of physical treatments is the UK Back Pain Exercise And Manipulation Trial (UK BEAM). In this trial we found that, when compared with ‘best care’ in general practice [8, 9], a package of spinal manipulation [10] produced a small to moderate benefit at 3 months and a small benefit at 1 year; that a programme of exercise [11] produced a small benefit at 3 months but not 12 months; and that manipulation followed by exercise produced a moderate benefit at 3 months and a small benefit at 1 year [12]. These effects are less than those we sought when designing this trial; however, the economic analysis suggests that these treatments are cost-effective additions to general practice treatment [13]. To explore these effects further we analysed participants’ views on the treatments they received within the UK BEAM trial, which were expressed as free text at the end of the questionnaire, with a view to gaining some insight into why the treatments were less effective than we had hoped.

Methods

We have reported our methods and results of the main trial in detail elsewhere [12–14].

Participant recruitment and follow-up

We recruited 1334 participants aged 18–64 from 181 general practices from the Medical Research Council General Practice Research Framework (http://mrc-gprf.ac.uk/) in 14 clusters across the UK. All participants had consulted these practices with simple low back pain. To exclude those people whose pain would resolve rapidly without treatment, all participants had had pain for at least 4 weeks when randomized. The Northern and Yorkshire Multi-Centre Ethics Committee provided the ethical review.

Interventions

We used a factorial design to compare ‘best care in general practice’—the control treatment, in which we trained practice teams in the active management of back pain [9, 12], and they provided participants with copies of The Back Book [15]—with (i) an exercise programme consisting of an initial individual assessment followed by up to nine group classes over 12 weeks delivered in community facilities [11], and (ii) a spinal manipulation package delivered in roughly equal proportions by chiropractic, osteopathic and physiotherapy professionals [10]. We invited participants to attend up to eight sessions over up to 12 weeks. Some participants received manipulation followed by exercise; for clarity we have not included data from these participants in this analysis. All practitioners providing treatment across all arms of the study were asked to provide positive and non-threatening messages to patients, encouraging a return to normal activities consistent with the Royal College of General Practioners guidelines and The Back Book.

Qualitative data

Participants were followed up using postal questionnaires at 1, 3 and 12 months following randomization. In our baseline questionnaire and at each follow-up we invited participants to provide general comments about their back pain. The whole final page of the questionnaire (A4 size) was available for their response. It is these data that we have analysed here. We have analysed comments regarding best care in general practice, the manipulation package and the exercise programme separately. All free text comments, ranging in length from single sentences to lengthy paragraphs, were transcribed verbatim into an Access database and then formatted for an Excel spreadsheet for the analysis. The free text comprised participants’ descriptions of their experiences and was not recorded as predominately either negative or positive. Instead the comments were considered as illuminating participants’ perceived rather than their actual experience. We found no obvious dissonant cases, i.e. individuals whose responses could not be accommodated within our analytical framework. This may reflect the constraints of expressing oneself fully by means of a free text box.

Data analysis

We initially mapped the free text data using a modified framework approach [16] to disaggregate, systematically, the qualitative data. The modification involved our attempt to explore emergent themes from individuals’ limited free text. Unlike that arising from conventional qualitative semi-structured interviews, our data were not information-rich, i.e. allowing us to locate individuals’ responses in a broader context. Instead we had only fragmented accounts of respondents’ experiences. Nevertheless, we were able to develop an index of pertinent issues generated from these data, in accordance with patients’ treatment allocation. These issues were then collated to form loosely constructed categories, which we examined to identify emergent themes. These themes emerged from a systematic process involving initial data reduction. This comprised selecting those excerpts of transcripts which provided our initial focus, assembling these data into matrices to identify the main direction of our analysis, and finally developing a content analytical interpretation of these matrices.

Results

We recruited 1334 participants. Follow-up questionnaires were received from 1118 (84%), 1029 (77%) and 995 (75%) participants at 1, 3 and 12 months, respectively. We received written comments from 157/1334 (12%), 365/1118 (33%), 389/1029 (38%) and 348/995 (35%) of the baseline, 1-, 3- and 12-month questionnaires, respectively. It is these comments that are the basis of this analysis.

Best care in general practice (Table 1)

One strong theme to emerge from participants allocated to best care in general practice was a perception of the ineffectual nature of back pain management by their general practitioners (GPs). Some participants reported positive experiences following advice from their GP, but there was a sense amongst many participants that GPs were non-specialists who had only medicines to offer by way of treatment. This perception of the GP as non-expert and back pain problem needing ‘expert’ treatment might reflect the fact that people assigned to this form of treatment felt they were being denied more specific help.

There was also a sense that drugs, which were considered to be the principal solution available from GPs, were inappropriate for back pain. Those allocated to a ‘GP only’ treatment regimen were therefore disappointed not to receive any special or individually tailored ‘expert’ treatment.

Several respondents referred to the GP as being unable adequately to address their back pain—as they had presumably had previous access to their GP. Consequently, the GP was considered unable to offer anything other than medicines.

Some expressed their disappointment in terms of being relegated to a service which had not succeeded in managing their back pain effectively, describing a GP consultation variously as ‘a waste of time because all you get is tablets’ (685-11-2052), or unnecessary because ‘he just gives me a prescription for painkillers’ (616-10-2006) or prescribes ‘a little time off work and to take some ibuprofen’ (487-13-2050). Receipt of a prescription from a GP has been analysed by some researchers as a ‘gift’, affirming the therapeutic nature of the relationship [17]. However, for some participants in this study, this was considered far from the case. Some construed it as an affirmation that the GP had exhausted the range of services he/she could offer and ‘could do no more’ (728-13-2094), while others took a less charitable view, claiming that GPs only ‘palm me off with anti-inflammatory pills’ (328-15-2021).

Despite the misgivings of some about GPs’ tendency to prescribe medication for back pain, it was clearly one effective means of exercising some control over their pain. One recurrently cited concern was over the sustainability of a long-term pharmacological approach to back pain management. This concern over the possible long-term and short-term effects of the medicines led some to reconsider their regular use. While medicines have a place in controlling pain, they did not provide what the patients required, namely addressing the cause rather than their symptomatic pain.

Being offered guidance on self-help was considered by some to be considerably more efficacious. Receiving a plausible explanation about the cause of the back pain which accorded with the patients’ own views had a significant empowering effect in enabling them to self-manage their pain effectively. However, receiving such an explanation was reportedly the exception rather than the rule, despite the fact that practices were offered training in an active management strategy.

Manipulation package (Table 2)

A notable feature for participants who were randomized to the manipulation package was a perception of the appropriateness of their treatment, that is, physical rather than pharmacological. Some subjects were effusive about the efficacy of manipulatory treatment, with reports that their therapies were spectacularly effective. However, in many cases the success was put down to the guidance and individual exercise programme accompanying their manipulation therapy. Some perceived improvement was due to receiving an explanation for their pain. Moreover, the benefit for these patients extended beyond their back pain to other aspects of their life, such as regulating weight gain/loss. However, several respondents commented that their pain was getting worse or had not improved as a consequence of joining the treatment regimen.

The experience of the manipulation package, although initially perceived to be useful, was reported to have left some patients feeling that they were back at square one. After an initial positive effect following their therapy, when it finished some reported their pain returning. For some patients it appears the positive effect depended on having the therapist continue to provide the treatment. An alternative explanation for these findings is that some subjects were becoming dependent on their therapist.

Exercise programme (Table 3)

Several issues emerged from participants assigned to this therapy, the majority of whom evaluated it positively. Even those who found the exercises caused them some discomfort appreciated the positive effects exercise provided. Some, however, felt that, despite the virtue of exercises, they were beyond help. The benefits of exercise were reported by participants to be both physical and mental. Exercise classes, in addition to having a positive effect on mental health, also fostered a sense of self-reliance in managing back pain. This was frequently expressed in terms of a sense of discipline or structure in the lives of participants, which the exercise programme provided. Despite their positive experience of supervised exercises, some admitted to being insufficiently motivated to continue their exercise regimen outside of the classes. For those sufficiently motivated to continue with their exercises, the result was, for many, a new sense of being enabled or ‘taught’ to self-manage their back pain. For some this simply followed from their continuing their exercises outside the class at home. For others it involved attending a gym on a regular basis, sometimes under a GP referral scheme. The perception of exercises as providing a sense of control of their back pain was not, however, shared by all. For some participants who were already physically active, exercise held no promise of improving their back pain—indeed, these participants had already decided that exercise was an ineffective treatment.

Discussion

This study has provided some interesting insights into the experience of the UK BEAM treatments and patients’ perceptions of the treatment they received. There are some limitations to our analysis. In modifying a framework approach, we necessarily compromised the scope of our analysis, limiting the robustness of our interpretation because our analysis was founded on brief written comments received from a minority of participants rather than a detailed narrative collected from a carefully selected sample. It is likely that those with particularly good or particularly bad experiences within the trial were more likely to complete this optional part of the questionnaire, producing polarized views on participants’ experience. Our analysis was therefore potentially biased against those whose perceived experiences were more neutral and therefore not recorded. Nonetheless, this approach did allow us to make use of comments from a considerable number of individuals, although data perforce are incomplete. The data are also relatively superficial and cannot be seen as a substitute for careful analysis of more detailed interviews in which the interviewer has explored the participants’ beliefs and experiences in detail [18]. These data were collected in the rather artificial environment of a randomized controlled trial, which means that our findings may not be directly transferable to the normal clinical situation. Nevertheless, these data do give us some insight into patients’ perceptions of their experiences when allocated to three different treatment approaches for back pain. This could inform our future management strategies.

We are unaware of any previous studies that have been able to compare patient experiences of different primary care approaches to treating back pain. An important strength of this study is that within a randomized controlled trial we can be sure that participants’ prior beliefs and experiences did not affect their choice of treatment.

The most striking observation from these data is the contrast between the benefits reported by participants across the three treatment groups. In the main quantitative analysis, differences between the outcomes on the main measures were less clear. In this qualitative analysis, GPs were often seen as nothing more than purveyors of drugs—issuing pain killers without any real understanding of what was causing the patient's pain—whilst participants randomized to the manipulation arm of the study saw the practitioners as experts delivering, in many cases exactly, what was needed in terms of hands-on therapy accompanied by credible explanations for their pain. This distinction between the GP as non-expert and back pain problems needing ‘expert’ treatment might reflect the fact that people assigned to best care in general practice felt they were being denied more specific help.

Participants randomized to the exercise programme had the least opportunity to assume a passive stance in relation to their therapy. Unlike those assigned to the manipulation package, participants assigned to the exercise programme were required to participate directly in the management of their back pain. In this respect, responsibility for managing their back pain was placed on the participants themselves—with the exercise sessions providing guidance in undertaking therapeutic exercise. These participants perceived both physical and mental benefits from the exercise programme. These observations are consistent with the main quantitative analysis in that it produced changes in some attitudinal scales as well as short-term benefits related to function and pain reduction. Randomization to the manipulation package was associated with a sustained benefit in measures of spinal pain and disability.

However, it is clear that there is a substantial difference in the reported experience of participants in the three groups that was not reflected in the effect size observed in the main quantitative analysis. There is a great range of comments amongst the participants in each group; some reported good experience of GP care and some reported that they were made worse by the manipulation package or the exercise programme. Additionally, there is a suggestion that these contrasting reports relate to ‘resentful demoralization’ [19], in which those randomized to GP care felt that they had been deprived of access to improved treatment and that GP care was simply providing more of a treatment that had already failed. To a lesser extent this was also evident in the exercise group, with some participants, who already exercised regularly, feeling that there could be no additional benefit from the exercise programme. This may be an important observation when considering the selection criteria for any future study of similar exercise programmes. Clearly, a moderately light exercise programme such as that used in UK BEAM is less likely to benefit those who are already exercising regularly. Only a small proportion of people with chronic pain choose active strategies such as exercise to cope with their problem: those who tend to report lower levels of pain [20]. When patients’ preferences were elicited within another trial of exercise, 63% preferred to be allocated to this, while the rest did not express a preference [21].

It is well recognized that patient satisfaction with treatment might not relate to outcome as measured though validated questionnaires. However, this analysis reveals a broader range of issues that may not be adequately identified using our standard outcome measures. In other studies, patients have reported greater satisfaction with an intervention that includes a hands-on approach compared with one that does not, even though health-related quality of life measures may fail to show any difference in change over time [22, 23]. Patients’ expectations of benefit from particular treatment approaches may be an important factor in the outcome of, and satisfaction with, low back pain treatments that is compounded by the gap between what is offered by health-care providers and what patients expect [24, 25].

One explanation for our findings is that those randomized to exercise or manipulation had greater time and attention paid to them. However, some other studies of physiotherapy show little additional benefit to clinical outcomes from greater exposure to conventional physiotherapy [26, 27].

Our work suggests that current outcome measures may not fully measure the effects noted by patients. There is a suggestion from these data that randomized controlled trials on their own may not always be the most appropriate means of assessing physical treatments for low back pain. Another, possibly better, approach is to carry out an in-depth qualitative study nested within a randomized controlled trial. A suitable subsample of patients can then be selected across different arms of the study. However, careful consideration must be given to the potential risk of biasing or polarizing patients’ views during the qualitative interview, which in turn could influence their response within the quantitative study.

In summary, this analysis supports the view that the process of care for those with low back pain is a complex subject that can affect the interpretation of clinical trial results. Those designing future randomized controlled trials of physical treatments for low back pain need to give more consideration to understanding what goes on within the consultation, how to measure the outcome or outcomes of interest, and whether randomized controlled trials are always the best tool to address the research question.

UK BEAM was funded by the Medical Research Council and NHS Research and Development. We are grateful to Suzanne Parsons for comments on an earlier version of this paper.

M.R.U. has accepted speaker fees from the General Osteopathic Council.

References

Author notes

1Centre for Health Sciences, Barts and The London, 2Department of General Practice and Primary Care, Peninsular Medical School, 3Institute of Rehabilitation, University of Hull.