Effectiveness and cost-effectiveness of three types of physiotherapy used to reduce chronic low back pain disability: a pragmatic randomized trial with economic evaluation.

STUDY DESIGN: Pragmatic, randomized, assessor blinded, clinical trial with economic analysis. OBJECTIVE: To compare the effectiveness and cost-effectiveness of three kinds of physiotherapy commonly used to reduce disability in chronic low back pain. SUMMARY OF BACKGROUND DATA: Physiotherapy reduces disability in chronic back pain, but there are several forms of physiotherapy and it is unclear which is most effective or cost effective. METHODS: A total of 212 patients referred to physiotherapy with chronic low back pain were randomized to receive usual outpatient physiotherapy, spinal stabilization classes, or physiotherapist-led pain management classes. Primary outcome was Roland Disability Questionnaire score 18 months from baseline; secondary measures were pain, health-related quality of life, and time off work. Healthcare costs associated with low back pain and quality-adjusted life years (QALYs) were also measured. RESULTS.: A total of 71 participants were assigned to usual outpatient physiotherapy, 72 to spinal stabilization, and 69 to physiotherapist-led pain management. A total of 160 (75%) provided follow-up data at 18 months, showing similar improvements with all interventions: mean (95% confidence intervals) Roland Disability Questionnaire score improved from 11.1 (9.6-12.6) to 6.9 (5.3-8.4) with usual outpatient physiotherapy, 12.8 (11.4-14.2) to 6.8 (4.9-8.6) with spinal stabilization, and 11.5 (9.8-13.1) to 6.5 (4.5-8.6) following pain management classes. Pain, quality of life, and time off work also improved within all groups with no between-group differences. Mean (SD) healthcare costs and QALY gain were pound474 (840) and 0.99 (0.27) for individual physiotherapy, pound379 (1040) and 0.90 (0.37) for spinal stabilization, and pound165 (202) and 1.00 (0.28) for pain management. CONCLUSIONS: For chronic low back pain, all three physiotherapy regimens improved disability and other relevant health outcomes, regardless of their content. Physiotherapist-led pain management classes offer a cost-effective alternative to usual outpatient physiotherapy and are associated with less healthcare use. A more widespread adoption of physiotherapist-led pain management could result in considerable cost savings for healthcare providers.

Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms: the NASA2 and SPACE2 studies.

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclo-oxygenase-2 (COX-2) inhibitors, cause upper gastrointestinal (GI) symptoms that are relieved by treatment with esomeprazole. We assessed esomeprazole for maintaining long-term relief of such symptoms. Six hundred and ten patients with a chronic condition requiring anti-inflammatory therapy who achieved relief of NSAID-associated symptoms of pain, discomfort, or burning in the upper abdomen during two previous studies were enrolled and randomly assigned into two identical, multicentre, parallel-group, placebo-controlled studies of esomeprazole 20 mg or 40 mg treatment (NASA2 [Nexium Anti-inflammatory Symptom Amelioration] and SPACE2 [Symptom Prevention by Acid Control with Esomeprazole] studies; ClinicalTrials.gov identifiers NCT00241514 and NCT00241553, respectively) performed at various rheumatology, gastroenterology, and primary care clinics. Four hundred and twenty-six patients completed the 6-month treatment period. The primary measure was the proportion of patients with relapse of upper GI symptoms, recorded in daily diary cards, after 6 months. Relapse was defined as moderate-to-severe upper GI symptoms (a score of more than or equal to 3 on a 7-grade scale) for 3 days or more in any 7-day period. Esomeprazole was significantly more effective than placebo in maintaining relief of upper GI symptoms throughout 6 months of treatment. Life-table estimates (95% confidence intervals) of the proportion of patients with relapse at 6 months (pooled population) were placebo, 39.1% (32.2% to 46.0%); esomeprazole 20 mg, 29.3% (22.3% to 36.2%) (p = 0.006 versus placebo); and esomeprazole 40 mg, 26.1% (19.4% to 32.9%) (p = 0.001 versus placebo). Patients on either non-selective NSAIDs or selective COX-2 inhibitors appeared to benefit. The frequency of adverse events was similar in the three groups. Esomeprazole maintains relief of NSAID-associated upper GI symptoms in patients taking continuous NSAIDs, including selective COX-2 inhibitors.