Randomized trial of two physiotherapy interventions for primary care back and neck pain patients: cost effectiveness analysis.

OBJECTIVES: To assess the cost-effectiveness of a brief physiotherapy pain management approach using cognitive-behavioural principles (Solution-Finding Approach) when compared with a commonly used traditional method of physical therapy (McKenzie Approach). METHODS: Economic evaluation conducted alongside a randomized trial. The study related incremental differences in costs and benefits associated with the Solution Finding and McKenzie approaches over 12 months. Costs were measured in UK pounds sterling. Benefit was measured as health-related quality of life using the EQ-5D, which was used to estimate patient-specific quality adjusted life years (QALYs). RESULTS: The McKenzie treatment required, on average, one extra physiotherapist visit (4.15 vs 3.10). Over a 12-month period, Solution Finding was associated with a lower per patient cost of pound-24.4 (95% CI pound-49.6 to 0.789 pounds). The mean difference in QALYs between the two groups was -0.020 (95% CI -0.057 to 0.017); favouring those receiving McKenzie. Relating incremental mean costs and QALYs gave an incremental cost effectiveness ratio of 1220 pounds (-24.4/-0.020) suggesting the McKenzie treatment is cost effective. CONCLUSIONS: Results suggest that the additional cost associated with the McKenzie treatment when compared with the Solution Finding Approach may be worth paying, given the additional benefit the approach seems more likely to provide. Further research is needed to assess the extent to which the difference in physiotherapy visits between the two strategies is generalizable to other treatment settings.

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

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.

UK Back pain Exercise And Manipulation (UK BEAM) trial--national randomised trial of physical treatments for back pain in primary care: objectives, design and interventions [ISRCTN32683578].

BACKGROUND: Low back pain has major health and social implications. Although there have been many randomised controlled trials of manipulation and exercise for the management of low back pain, the role of these two treatments in its routine management remains unclear. A previous trial comparing private chiropractic treatment with National Health Service (NHS) outpatient treatment, which found a benefit from chiropractic treatment, has been criticised because it did not take treatment location into account. There are data to suggest that general exercise programmes may have beneficial effects on low back pain. The UK Medical Research Council (MRC) has funded this major trial of physical treatments for back pain, based in primary care. It aims to establish if, when added to best care in general practice, a defined package of spinal manipulation and a defined programme of exercise classes (Back to Fitness) improve participant-assessed outcomes. Additionally the trial compares outcomes between participants receiving the spinal manipulation in NHS premises and in private premises. DESIGN: Randomised controlled trial using a 3 x 2 factorial design. METHODS: We sought to randomise 1350 participants with simple low back pain of at least one month's duration. These came from 14 locations across the UK, each with a cluster of 10-15 general practices that were members of the MRC General Practice Research Framework (GPRF). All practices were trained in the active management of low back pain. Participants were randomised to this form of general practice care only, or this general practice care plus manipulation, or this general practice care plus exercise, or this general practice care plus manipulation followed by exercise. Those randomised to manipulation were further randomised to receive treatment in either NHS or private premises. Follow up was by postal questionnaire one, three and 12 months after randomisation. The primary analysis will consider the main treatment effects before interactions between the two treatment packages. Economic analysis will estimate the cost per unit of health utility gained by adding either or both of the treatment packages to general practice care.

Responsiveness of generic and specific measures of health outcome in low back pain.

STUDY DESIGN: A longitudinal study using patient questionnaires was performed. OBJECTIVE: To compare the discriminatory power and responsiveness of the Aberdeen Back Pain Scale (ABPS), the Roland Disability Questionnaire (RDQ), and the EuroQol in patients with low back pain. SUMMARY OF BACKGROUND DATA: A number instruments specific to low back pain have not been compared for measurement properties. The EuroQol is a widely used generic instrument that has not been compared with specific instruments in patients with back pain. METHODS: A questionnaire incorporating the Aberdeen Back Pain Scale, the Roland Disability Questionnaire, and the EuroQol was completed by patients taking part in a clinical trial of exercise treatments for back pain. Patients completed follow-up questionnaires at 6 weeks, 6 months, and 1 year. The discriminatory power of these instruments was assessed against variables relating to activity limitations, medication, and comorbidity. Responsiveness was assessed using standardized response means. RESULTS: The questionnaire was completed by 187 patients taking part in the clinical trial. The Aberdeen instrument was found to be the most powerful at discriminating between different groups of patients on variables relating to activity limitations, medication, and comorbidity. The specific instruments demonstrated good levels of responsiveness, with the Aberdeen instrument producing the largest standardized response means. The Aberdeen instrument was more responsive to the smaller changes experienced by the control group, but was less powerful than the Roland at measuring differences in the levels of change between the two groups of patients at two of the three follow-up assessments in the trial. The EuroQol demonstrated a moderate level of responsiveness. CONCLUSIONS: The two specific instruments are capable of greater levels of discrimination between groups of patients, and are more responsive over time than the generic EuroQol. The Aberdeen instrument performed most satisfactorily in relation to these criteria, but the Roland instrument was more sensitive to differences between the two groups in the clinical trial. The measurement properties of these two instruments reflect their origin: The Aberdeen instrument is based on clinical questions, whereas the Roland instrument is based on the generic Sickness Impact Profile. Instrument content should be carefullyconsidered when selecting instruments for applications, including clinical trials.

Individuals with low back pain: how do they view physical activity?

BACKGROUND: Recent guidelines for those with acute low back pain have advocated early resumption of normal activity and increased physical activity. Little is known about the relationship between low back pain and physical activity, and on the impact of that relationship on the promotion of increased levels of physical activity within a general practice population. OBJECTIVES: We aimed to explore associations between factors that influence changes in physical activity and the way individuals perceive and behave with their low back pain, and the impact of those perceptions and behaviour on physical activity. METHODS: Twenty-seven informants were chosen using a purposive sample from a larger group of individuals who, because of their low back trouble, had been referred by their GPs to a community-based, single-blind, randomized controlled trial (RCT) at the University of York, which is evaluating the effectiveness and cost-effectiveness of a progressive exercise programme. Fifty-four interviews were conducted with this subgroup of the RCT; four informants were interviewed once, 19 twice and four of them three times. Interviews were transcribed and analysed using manual and computer-aided approaches. RESULTS: Physical activity was perceived as (i) activities of daily living, (ii) activities causing breathlessness that they went out of the way to do and (iii) more competitive-type activity. The avoidance of physical activity and fear of pain returning were the two main factors directly associated with informants' backs and changes in physical activity. These two factors hindered increases in physical activity, even though the majority of informants believed strongly that being physically active helped ease their low back pain. CONCLUSIONS: When advocating that individuals with acute low back pain return to or increase physical activity, it is important that clinicians identify avoidance of physical activity and/or fear of pain at the earliest stage in order to tailor advice and reassurance appropriately. If avoidance of activity and fear of pain is identified and clinicians want to encourage patients to take up and sustain increased physical activity, they should explore issues of fear of pain, and avoidance of and confidence to do physical activities, in addition to other factors influencing physical activity.

A fitness programme for patients with chronic low back pain: 2-year follow-up of a randomised controlled trial.

The aim of this study was to assess the long-term effect of a supervised fitness programme on patients with chronic low back pain. The design of the study was a single blind randomised controlled trial with follow-up, by postal questionnaire, 2 years after intervention. The Oswestry Low Back Pain Disability Index was used as the outcome measure to assess daily activity affected by back pain. Eighty-one patients with chronic low back pain, who were referred to the physiotherapy department of a National Health Service orthopaedic hospital, were randomised to either a supervised fitness programme or a control group. Patients in the intervention group and control group were taught specific exercises to be continued at home and referred to a backschool for back care education. In addition, the intervention group attended eight sessions of a supervised fitness programme. Sixty-two patients (76%) with a mean age of 37 years, returned the Oswestry Low Back Pain Disability Index questionnaire. Of these, 29 were in the intervention group and 31 in the control group. Patients in the intervention group demonstrated a mean reduction of 7.7% in the Oswestry Low Back Pain Disability Index score (95% confidence interval of mean paired difference 3.9, 11.6 P < 0.001), compared with only 2.4% in the control group (95% confidence interval of mean paired difference -2.0, 6.9 P > 0.05). Between group comparisons demonstrated a statistically significant difference in disability scores between the treatment and control group (mean difference 5.8, 95% confidence interval 0.3, 11.4 P < 0.04). This study supports the current trend towards a more active treatment approach to low back pain. We have demonstrated clinical effectiveness of a fitness programme 2 years after treatment but this needs to be replicated in a larger study which should include a cost effectiveness analysis, further analysis of objective functional status and a placebo intervention group.

Patient preferences in randomised trials: threat or opportunity?

OBJECTIVES: To assess whether it is feasible to elicit patients' preferences for treatments and then to proceed with randomisation which may allocate those with preferences to their less preferred treatment; and to describe which prognostic variables were associated with such preferences within the context of a randomised trial of an exercise programme for back pain. METHODS: The first 97 patients enrolled in a randomised controlled trial (RCT) for the treatment of back pain were asked about their preferences, health characteristics and other prognostic variables. RESULTS: Fifty-eight (60%) patients preferred to be allocated to the exercise programme whilst 38 (39%) were indifferent; one patient preferred conventional general practitioner (GP) management. No patient refused randomisation. Comparing patients preferring the exercise programme with indifferent patients showed that the former had a higher belief in the effectiveness of the new treatment (P < 0.01), tended to have worse back pain (P = 0.09), had back pain for a shorter duration (P = 0.04), and tended to have had more GP home visits (P = 0.06). CONCLUSIONS: For many randomised trials preference may be an important prognostic variable. In such circumstances, preference should be taken into account in the final analysis. This study demonstrates it is sometimes feasible to randomise patients to their less preferred treatment, thus allowing more robust statistical comparisons between randomised groups. This modification may make RCTs more rigorous and improve their external validity.

A placebo controlled double blind trial to evaluate the effectiveness of pulsed short wave therapy for osteoarthritic hip and knee pain.

The aim of this study was to investigate the effectiveness of pulsed short wave (PSW) in the relief of pain in osteoarthritis of the hip and knee. Ninety-two patients, mean age 63 years, (34 men and 58 women) were randomly allocated to one of three groups: (1) Active PSW, using the dosage found in a pilot study to be non-significantly most effective, (2) Placebo PSW, (3) No treatment control group. Nine sessions of treatment were provided over a 3-week period, each application lasting for 15 min. The machine was modified by the manufacturers so that the therapist was able to administer the treatment and carry out assessments without being aware of the treatment allocation. Outcome measures included sensory and affective pain diary reports averaged over days and weeks, self-reported benefit and the General Health Questionnaire. Analysis of variance with repeated measures over time was used to find out if the active treatment had a specific effect, incremental to the placebo effect. There were no significant differences between the active and placebo groups over time. According to the pain diary reports, both active and placebo groups tended to improve slightly during treatment, but worsened after its withdrawal. Patients who were given the placebo application tended to report more benefit than those who had the active treatment, although this did not quite reach statistical significance (P < 0.06). Patients who were not on a waiting list for surgery did significantly better over time than those who were (P < 0.03). There were no significant differences between the groups over time for the other outcome variables. Any treatment effect on this patient population appears to have been largely placebo-mediated. No evidence was found therefore for the specific effectiveness of PSW for treatment of osteoarthritic hip or knee pain.

Randomised controlled trial for evaluation of fitness programme for patients with chronic low back pain.

OBJECTIVE: To evaluate a progressive fitness programme for patients with chronic low back pain. DESIGN: Single blind randomised controlled trial. Assessments were carried out before and after treatment by an observer blinded to the study and included a battery of validated measures. All patients were followed up by postal questionnaire six months after treatment. SETTING: Physiotherapy department of orthopaedic hospital. SUBJECTS: 81 patients with chronic low back pain referred from orthopaedic consultants for physiotherapy. The patients were randomly allocated to a fitness programme or control group. INTERVENTION: Both groups were taught specific exercises to carry out at home and referred to a back-school for education in back care. Patients allocated to the fitness class attended eight exercise classes over four weeks in addition to the home programme and backschool. RESULTS: Significant differences between the groups were shown in the changes before and after treatment in scores on the Oswestry low back pain disability index (P < 0.005), pain reports (sensory P < 0.05 and affective P < 0.005), self efficacy reports (P < 0.05), and walking distance (P < 0.005). No significant differences between the groups were found by the general health questionnaire or questionnaire on pain locus of control. A benefit of about 6 percentage points on the disability index was maintained by patients in the fitness group at six months. CONCLUSION: There is a role for supervised fitness programmes in the management of moderately disabled patients with chronic low back pain. Further clinical trials, however, need to be established in other centres to confirm these findings.

A longitudinal study of low back pain in student nurses.

Results from a longitudinal study of low back pain in 199 student nurses followed up for 20 months show that 37% reported back pain which lasted for at least 3 consecutive days. The first incidence peaked markedly between 9 and 12 months into training, and coincided with work on wards described by the nurses as "heavy". A combination of personal characteristics are also associated with back pain reports, within this group of nurses. These include attitudes to health as measured by the Health Locus of Control, low levels of trait anxiety, increased neuroticism, and emotional disturbance as measured by the General Health Questionnaire, the strength endurance of the thigh muscles (quadriceps), and height. Recommendations are made for: (1) the consideration of a modified training programme for lifting and handling; and (2) the need for a standardized system of recording back problems as suggested by the DHSS-commissioned Robens Institute (University of Surrey) Report.

A controlled, prospective study to evaluate the effectiveness of a back school in the relief of chronic low back pain.

Ninety-two chronic low back pain patients were randomly allocated to two groups to evaluate the effectiveness of a back school compared with an exercise-only regimen according to specified outcome variables. The data from 78 patients with 7 years mean duration of symptoms was analyzed. Three assessments were made: before treatment and 6 and 16 weeks after treatment. Changes in patients' levels of pain, functional disability, and other related variables were compared in the two groups. Almost all variables showed an improvement at 6 weeks. At 16 weeks, functional disability and pain levels showed a significant difference. Back school patients continued to make an improvement. This method of managing low back pain makes maximal use of limited resources and appears to be effective, especially in the longer term.