STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To determine 1) whether, among patients with persistent disabling low back pain (LBP), a group program of exercise and education using a cognitive behavioral therapy (CBT) approach, reduces pain and disability over a subsequent 12-month period; 2) the cost-effectiveness of the intervention; and 3) whether a priori preference for type of treatment influences outcome. SUMMARY OF BACKGROUND DATA: There is evidence that both exercise and CBT delivered in specialist settings is effective in improving LBP. There is a lack of evidence on whether such interventions, delivered by trained individuals in primary care, result in improved outcomes. METHODS: The study was conducted in nine family medical practices in East Cheshire, UK. Patients 18 to 65 years of age, consulting with LBP, were recruited; those still reporting LBP 3 months after the initial consultation were randomized between the two trial arms. The intervention arm received a program of eight 2-hour group exercise session over 6 weeks comprising active exercise and education delivered by physiotherapists using a CBT approach. Both arms received an educational booklet and audio-cassette. The primary outcome measures were pain (0-100 Visual Analogue Scale) and disability (Roland and Morris Disability Scale; score 0-24). RESULTS: A total of 196 subjects (84%) completed follow-up 12 months after the completion of the intervention program. The intervention showed only a small and nonsignificant effect at reducing pain (-3.6 mm; 95% confidence interval, -8.5, 1.2 mm) and disability (-0.6 score; 95% confidence interval, -1.6, 0.4). The cost of the intervention was low with an incremental cost-effectiveness ratio of pound5000 (U.S. $8650) per quality adjusted life year. In addition, patients allocated to the intervention that had expressed a preference for it had clinically important reductions in pain and disability. CONCLUSIONS: This intervention program produces only modest effects in reducing LBP and disability over a 1-year period. The observation that patient preference for treatment influences outcome warrants further investigation.
RCT Entities:
STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To determine 1) whether, among patients with persistent disabling low back pain (LBP), a group program of exercise and education using a cognitive behavioral therapy (CBT) approach, reduces pain and disability over a subsequent 12-month period; 2) the cost-effectiveness of the intervention; and 3) whether a priori preference for type of treatment influences outcome. SUMMARY OF BACKGROUND DATA: There is evidence that both exercise and CBT delivered in specialist settings is effective in improving LBP. There is a lack of evidence on whether such interventions, delivered by trained individuals in primary care, result in improved outcomes. METHODS: The study was conducted in nine family medical practices in East Cheshire, UK. Patients 18 to 65 years of age, consulting with LBP, were recruited; those still reporting LBP 3 months after the initial consultation were randomized between the two trial arms. The intervention arm received a program of eight 2-hour group exercise session over 6 weeks comprising active exercise and education delivered by physiotherapists using a CBT approach. Both arms received an educational booklet and audio-cassette. The primary outcome measures were pain (0-100 Visual Analogue Scale) and disability (Roland and Morris Disability Scale; score 0-24). RESULTS: A total of 196 subjects (84%) completed follow-up 12 months after the completion of the intervention program. The intervention showed only a small and nonsignificant effect at reducing pain (-3.6 mm; 95% confidence interval, -8.5, 1.2 mm) and disability (-0.6 score; 95% confidence interval, -1.6, 0.4). The cost of the intervention was low with an incremental cost-effectiveness ratio of pound5000 (U.S. $8650) per quality adjusted life year. In addition, patients allocated to the intervention that had expressed a preference for it had clinically important reductions in pain and disability. CONCLUSIONS: This intervention program produces only modest effects in reducing LBP and disability over a 1-year period. The observation that patient preference for treatment influences outcome warrants further investigation.
Authors: Karen J Sherman; Daniel C Cherkin; Laura Ichikawa; Andrew L Avins; Kristin Delaney; William E Barlow; Partap S Khalsa; Richard A Deyo Journal: Spine (Phila Pa 1976) Date: 2010-07-01 Impact factor: 3.468
Authors: Katherine L Beissner; Eileen Bach; Christopher M Murtaugh; MaryGrace Trifilio; Charles R Henderson; Yolanda Barrón; Melissa A Trachtenberg; M Carrington Reid Journal: Home Healthc Now Date: 2017-02
Authors: Helen Cox; Helen Tilbrook; John Aplin; Ling-Hsiang Chuang; Catherine Hewitt; Shalmini Jayakody; Anna Semlyen; Marta O Soares; David Torgerson; Alison Trewhela; Ian Watt; Gill Worthy Journal: Complement Ther Clin Pract Date: 2009-11-11 Impact factor: 2.446
Authors: Laxmaiah Manchikanti; Vidyasagar Pampati; Satya P Sanapati; Mahendra R Sanapati; Alan D Kaye; Joshua A Hirsch Journal: Curr Pain Headache Rep Date: 2020-01-30