Acupuncture Treatment of Lateral Elbow Pain: A Nonrandomized Pilot Study

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.

Mast Cell Degranulation and Adenosine Release:Acupoint Specificity for Effect of Electroacupuncture on Pituitrin‐Induced Acute Heart Bradycardia in Rabbits

“…Clinical practice suggests that acupoint specificity plays an important role in guiding clinical treatment [ 7 , 8 , 38 ]. Using the improved rabbit acute bradycardia model, a suitable animal model for the human bradycardia disease [ 26 ], we found that stimulating PC6 (the pericardium meridian, a clinical indicator of angina [ 39 , 40 ], arrhythmia [ 41 ], and gastritis [ 42 ]) with EA induced a significant increase in heart rate during bradycardia induced by acute myocardial ischemia in rabbits, and the recovery of relative heart rate was significantly higher than that in the LU7 (the lung meridian, a clinical indicator of cough [ 43 ] and headache [ 44 ]) and LI11 (the large intestine meridian, a clinical indicator of arm pain [ 45 ] and hypertension [ 46 ]) groups (Figures 4 and 5 ). This indicates that the effect of acupuncture cannot be obtained by applying EA stimulation on any random point on the body.…”

Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy

“…One of the research partners from the Changchun University of Chinese Medicine (WFC) had had extensive experience in treating lateral elbow pain and suggested a simple acupuncture technique consisting of two local acupoints (Large Intestine 10 and Large Intestine 11) and a specific needle technique (Wagging the Dragon's Tail). The research partners decided that a pilot study would be necessary to ensure that the technique was efficient and asked the Chinese research group to conduct a pilot study before incorporating the acupuncture technique [7]. …”

“…However, there is inconclusive evidence that needle acupuncture has a specific action in the treatment of this debilitating condition as shown by Gadau et al in the latest systematic review on the topic due to low methodological quality and the small sample sizes of the individual studies [6]. The result from a nonrandomised controlled pilot study ( n = 40) from our group suggests that acupuncture may be helpful in improving function and pain associated with LEP [7]. In this study, the treatment group ( n = 20) received nine unilateral acupuncture treatments at LI 10 and LI 11 on the affected side with manual needle manipulation while the control group ( n = 20) received nine sham-laser-acupuncture at the same acupoints.…”

“…Practitioners are required to apply a standardised intervention procedure to participants dependent on the participant's randomisation status. Acupoint selection was based on a consensus by all four recruiting centres following positive outcomes from the analysis of data generated from a pilot study undertaken by one of the research groups at Changchun University of Chinese Medicine [7]. …”

“…A blind third party at the Hong Kong site will undertake the statistical analysis following dual data entry, data checking, and revision. Sample size ( n = 96, 24 subjects for each site) was based on the China pilot study data associated with the primary outcome, the DASH questionnaire [7] (Liu et al, 2016).…”