Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial.

BACKGROUND: Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patient's prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control). METHODS: 1573 adults (aged ≥18 years) with back pain (with or without radiculopathy) consultations at ten general practices in England responded to invitations to attend an assessment clinic. Eligible participants were randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to intervention or control group. Primary outcome was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In the economic evaluation, we focused on estimating incremental quality-adjusted life years (QALYs) and health-care costs related to back pain. Analysis was by intention to treat. This study is registered, number ISRCTN37113406. FINDINGS: 851 patients were assigned to the intervention (n=568) and control groups (n=283). Overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4·7 [SD 5·9] vs 3·0 [5·9], between-group difference 1·81 [95% CI 1·06-2·57]) and at 12 months (4·3 [6·4] vs 3·3 [6·2], 1·06 [0·25-1·86]), equating to effect sizes of 0·32 (0·19-0·45) and 0·19 (0·04-0·33), respectively. At 12 months, stratified care was associated with a mean increase in generic health benefit (0·039 additional QALYs) and cost savings (£240·01 vs £274·40) compared with the control group. INTERPRETATION: The results show that a stratified approach, by use of prognostic screening with matched pathways, will have important implications for the future management of back pain in primary care. FUNDING: Arthritis Research UK.

Inequalities in primary care management of knee pain and disability in older adults: an observational cohort study.

OBJECTIVES: To describe primary care management of knee pain, in relation to National Institute for Health and Clinical Excellence (NICE) OA guidelines, and examine variation in management by patient characteristics. METHODS: Subjects were 755 adults aged ≥50 years who responded to baseline and 3-year surveys and had consulted primary care for knee pain. Medical records (1997-2006) were searched. Associations of having interventions from the outer circle (adjunctive treatments or Step 3) of the NICE guidelines with self-reported socio-demographic and knee-specific factors were determined. RESULTS: Eighty per cent had received a Step 3 intervention. Thirty-eight per cent had been referred to secondary care, and 10% had received a knee replacement. Forty-three per cent had been prescribed an opioid and 41% an NSAID. Severe knee pain or disability at baseline and follow-up was the main association with receiving a Step 3 intervention [adjusted odds ratio (OR) 2.26; 95% CI 1.38, 3.70] and with referral (OR 2.57; 95% CI 1.72, 3.83). Older patients were less likely to be referred. Although non-significant, those of higher social class, in more affluent areas, older age or overweight or obese, appeared more likely to receive a knee replacement. Fifty per cent of those reporting severe knee pain or disability in both surveys had not been referred to secondary care. CONCLUSION: Most of the older adults who consult primary care with knee pain receive at least one Step 3 intervention from the OA guidelines. Inequalities in the management and referral of knee problems in primary care were generally not observed, although there were some trends towards differences in likelihood of total knee replacement.

Transcutaneous electrical nerve stimulation for the management of tennis elbow: a pragmatic randomized controlled trial: the TATE trial (ISRCTN 87141084).

BACKGROUND: Tennis elbow is a common and often extremely painful musculoskeletal condition, which has considerable impact on individuals as well as economic implications for healthcare utilization and absence from work. Many management strategies have been studied in clinical trials. Whilst corticosteroid injections offer short term pain relief, this treatment is unpleasant and is used with caution due to an associated high risk of pain recurrence in the long term. Systematic reviews conclude that there is no clear and effective treatment for symptoms of pain in the first 6 weeks of the condition. There is a clear need for an intervention that is acceptable to patients and provides them with effective short-term pain relief without increasing the risk of recurrence. Transcutaneous electrical nerve stimulation (TENS) is an inexpensive, non-invasive, non-pharmacological form of analgesia that is commonly used in the treatment of pain. TENS has very few contraindications and is simple to apply. It also benefits from being patient controlled, thereby promoting self-management. This study aims to assess the effectiveness, in terms of pain relief, and cost-effectiveness of a self-management package of treatment that includes TENS. METHODS/DESIGN: The design of the study will be a two-group pragmatic randomized clinical trial. 240 participants aged 18 years and over with tennis elbow will be recruited from 20-30 GP practices in Staffordshire, UK. Participants are to be randomized on a 1:1 basis to receive either primary care management (standard GP consultation, medication, advice and education) or primary care management with the addition of TENS, over 6 weeks. Our primary outcome measure is average intensity of elbow pain in the past 24 hours (0-10 point numerical rating scale) at 6 weeks. Secondary outcomes include pain and limitation of function, global assessment of change, days of sick leave, illness perceptions, and overall health status. A cost-effectiveness analysis will also be performed. Patient adherence and satisfaction data will be collected at 6 weeks, 6 months and 12 months by postal questionnaire. A diary will also be completed for the first 2 weeks of treatment. Clinical effectiveness and cost-effectiveness analyses will be carried out using an intention-to-treat approach as the primary analysis. DISCUSSION: This paper presents detail on the rationale, design, methods and operational aspects of the trial. TRIAL REGISTRATION: Current Controlled Trials. ISRCTN87141084.

A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol.

BACKGROUND: Back pain is a major health problem and many sufferers develop persistent symptoms. Detecting relevant subgroups of patients with non-specific low back pain has been highlighted as a priority area for research, as this could enable better secondary prevention through the targeting of prognostic indicators for persistent, disabling symptoms. We plan to conduct a randomised controlled trial to establish whether subgrouping using a novel tool, combined with targeted treatment, is better than best current care at reducing long-term disability from low back pain. METHODS/DESIGN: We will recruit 800 participants aged 18 years and over with non-specific low back pain from 8-10 GP practices within two Primary Care Trusts in Staffordshire, England. Our primary outcome measures are low back pain disability and catastrophising. Secondary outcomes include back pain intensity, global change, leg pain, fear avoidance, anxiety, depression, illness perceptions, patient satisfaction, overall health status and cost-effectiveness. Data will be collected before randomisation, and 4 and 12 months later. Participants are randomised to receive either newly developed interventions, delivered by trained physiotherapists and targeted according to subgroups defined by tool scores, or best current care. DISCUSSION: This paper presents detail on the rationale, design, methods and operational aspects of the trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN37113406.