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Clinical effectiveness trials
▸ Hinman RS, McCrory P, Pirotta M. Acupuncture for chronic knee pain: a randomized clinical trial. JAMA 2014;312:1313–22.
Zelen design four-arm randomised controlled trial (RCT), N=282.
Zelen design clinical trial (randomisation occurred before informed consent) in Victoria, Australia. Community volunteers (282 patients aged ≥50 years with chronic knee pain) were treated by family physician acupuncturists. Patients were randomised to: no acupuncture (control group, n=71); needle acupuncture (n=70) using standardised points around the knee and distally; 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.
Primary outcomes were average knee pain (numerical rating scale, 0–10; minimal clinically important difference (MCID), 1.8 units) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0–68, 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.
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 and statistically significant 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 (figure 1). The authors conclude that, in patients older than 50 years …
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