Acupuncture for chronic knee pain: a randomized clinical trial. Author: Hinman RS1, McCrory P2, Pirotta M3, Relf I3, Forbes A4, Crossley KM5, Williamson E6, Kyriakides M3, Novy K3, Metcalf BR1, Harris A7, Reddy P8, Conaghan PG9, Bennell KL1. Affiliation: 1Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia. 2Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia2Florey Institute of Neuroscience and Mental Health. 3Department of General Practice, School of Medicine, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia. 4Epidemiology and Preventative Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia. 5Division of Physiotherapy, School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia. 6Farr Institute of Health Informatics Research, London, United Kingdom7Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom. 7Centre for Health Economics, Faculty of Business and Economics, Monash University, Melbourne, Australia. 8School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, Newcastle, Australia. 9Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, United Kingdom. Conference/Journal: JAMA Date published: 2014 Oct 1 Other: Volume ID: 312 , Issue ID: 13 , Pages: 1313-22 , Special Notes: doi: 10.1001/jama.2014.12660 , Word Count: 361 IMPORTANCE: There is debate about benefits of acupuncture for knee pain. OBJECTIVE: To determine the efficacy of laser and needle acupuncture for chronic knee pain. DESIGN, SETTING, AND PARTICIPANTS: Zelen-design clinical trial (randomization occurred before informed consent), in Victoria, Australia (February 2010-December 2012). Community volunteers (282 patients aged ≥50 years with chronic knee pain) were treated by family physician acupuncturists. INTERVENTIONS: No acupuncture (control group, n = 71) and needle (n = 70), laser (n = 71), and sham laser (n = 70) acupuncture. Treatments were delivered for 12 weeks. Participants and acupuncturists were blinded to laser and sham laser acupuncture. Control participants were unaware of the trial. MAIN OUTCOMES AND MEASURES: Primary outcomes were average knee pain (numeric rating scale, 0 [no pain] to 10 [worst pain possible]; minimal clinically important difference [MCID], 1.8 units) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 [no difficulty] to 68 [extreme difficulty]; MCID, 6 units) at 12 weeks. Secondary outcomes included other pain and function measures, quality of life, global change, and 1-year follow-up. Analyses were by intention-to-treat using multiple imputation for missing outcome data. RESULTS: At 12 weeks and 1 year, 26 (9%) and 50 (18%) participants were lost to follow-up, respectively. Analyses showed neither needle nor laser acupuncture significantly improved pain (mean difference; -0.4 units; 95% CI, -1.2 to 0.4, and -0.1; 95% CI, -0.9 to 0.7, respectively) or function (-1.7; 95% CI, -6.1 to 2.6, and 0.5; 95% CI, -3.4 to 4.4, respectively) compared with sham at 12 weeks. Compared with control, needle and laser acupuncture resulted in modest improvements in pain (-1.1; 95% CI, -1.8 to -0.4, and -0.8; 95% CI, -1.5 to -0.1, respectively) at 12 weeks, but not at 1 year. Needle acupuncture resulted in modest improvement in function compared with control at 12 weeks (-3.9; 95% CI, -7.7 to -0.2) but was not significantly different from sham (-1.7; 95% CI, -6.1 to 2.6) and was not maintained at 1 year. There were no differences for most secondary outcomes and no serious adverse events. CONCLUSIONS AND RELEVANCE: In patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12609001001280. Comment in Minimal clinically important difference: defining what really matters to patients. [JAMA. 2014] Summary for patients in JAMA. 2014 Oct 1;312(13):1365. PMID: 25268438