Abstract
In planning for a large-scale multicenter trial to evaluate the effect of acupuncture for the treatment of lateral elbow pain, a pilot study was conducted. This was a prospective, investigator- and patient-blinded, nonrandomized, placebo controlled trial. Subjects were evaluated at baseline, before fourth, seventh, and ninth treatment, and at a two-week posttreatment follow-up. The treatment group received unilateral acupuncture at LI 10 and LI 11 at the affected side with manual needle manipulation; the control group received sham-laser acupuncture at the same acupoints. Measures included (i) disabilities of the arm, shoulder, and hand (DASH) questionnaire, (ii) pain-free grip strength (PFGS), and (iii) a visual analogue scale (VAS) for pain. Significant differences in DASH score, PFGS, and VAS between treatment and control group were found at the ninth treatment (n = 20 for each group, P < 0.05). Only DASH showed significant differences compared to the control for all the measurement time points after treatment commenced and appears to be a sensitive and appropriate primary outcome measure for the future multisite trial. Results from this pilot study provided relevant information about treatment efficacy, credibility of control treatment, and sensitivity of different outcome measures for the planning of the future trial.
Highlights
In our latest review of the topic, we have found some evidence suggesting that acupuncture might be more effective than sham acupuncture or ultrasound treatment
Multisite randomized controlled trials (RCTs) can facilitate the adaptation of best practice in the selection of treatment protocols and outcome measures, as there are a larger number of experienced researchers involved in the design and execution of the trial
This study was designed to be a careprovider, assessor, and patient-blinded, nonrandomized, placebo controlled, parallel arm trial to evaluate the efficacy of acupuncture in the treatment of lateral elbow pain (LEP)
Summary
A high level of evidence supporting the use of acupuncture treatment for LEP is lacking [1,2,3,4]. It was found that there are many limitations associated with the previous studies, such as a lack of standardization of outcome measures, no clear statement of primary outcome measure, and much variation in the administration of acupuncture and in the selection of a control treatment [2]. We have planned to conduct a four-site trial in four countries/regions to determine the efficacy of acupuncture treatment for LEP, with the goal to minimize limitations of previous studies. Multisite RCTs can facilitate the adaptation of best practice in the selection of treatment protocols and outcome measures, as there are a larger number of experienced researchers involved in the design and execution of the trial
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
