Efficacy of "Zha Tiao" electroacupuncture for patients with knee osteoarthritis: study protocol for a randomized controlled trial

Abstract Background: Both Acupuncture and electroacupuncture have demonstrated effectiveness in treating knee osteoarthritis (KOA). Variations in acupuncturists' manipulations may lead to differing therapeutic outcomes. The aim of this trial is to determine the efficacy and safety of an acupuncture technique (Zha Tiao) which is characterized by eliciting muscle twitching as an objective manifestation, combine with electroacupuncture for KOA. Methods: In this randomized, placebo-controlled, single-blind trial, 78 patients with knee osteoarthritis (KOA) classified as K-L grade II or III were randomly assigned to receive either 'Zha Tiao' electroacupuncture (ZT-EA) or regular electroacupuncture (R-EA) three times weekly for four weeks in a 1:1 ratio. Participants, outcome assessors, and statisticians keep unware of treatment group assignment. Primary outcome assessments, including the visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), range of motion (ROM), Cross-Sectional Area (CSA) of quadriceps, fastest walking time over 15 meters, Short Form 12 (SF-12), axial alignment of the lower extremity and lower limb strength, were measured at baseline, during the treatment phase (at 2 and 4 weeks), and at follow-up visits (at 8 and 12 weeks). Adverse events occurring during the trial will be recorded and analyzed. In the event of subject withdrawal from the trial, intention-to-treat analysis (ITT) will be conducted. Expected Results and Conclusion: We expect this randomized trial to evaluate the effectiveness of Zha Tiao on relieving pain and increasing ability in KOA patients. The proposed acupuncture treatment might provide an alternative option for both doctor and patient. Trial registration: China Registered Clinical Trial Registration Center (ChiCTR2400085328). Registered on Jun. 05. 2024.