Warm Needle Acupuncture vs. Needle Acupuncture for Osteoarthritis of the Knee: A Pilot Study Protocol

Acupuncture has been shown to have clinically relevant benefits for chronic pain. However, interpretation of the results and whether they are due to the placebo effect remains contested. As a complex physical intervention acupuncture presents particular problems in clinical research that seeks to identify a specific effect. The existing evidence mosaic can be enhanced by randomised controlled trials that investigate the specific efficacy of different components of acupuncture. This study investigates the specific efficacy of the conducted heat in warm needle acupuncture. Methods: The study is a randomised, controlled, parallel-group 2-armed clinicaltrial. Itis designed so that the outcome administrator, participants and primary acupuncturist will be blinded to group allocation. Analysis: The primary outcome measures WOMACJ NRS 3.1 score and SF 36 are both considered interval variables and provided the distribution of changes is normally distributed the change in score will be analysed using t-test. The information obtained from interviews with participants will be thematically analysed. Discussion: Compromises from acupuncture in practice have been made in order to devise procedures that can investigate the specific efficacy of the conducted heat of warm needle acupuncture. The way in which these compromises may impact on interpretation of the results is discussed