Fire acupuncture for mild to moderate knee osteoarthritis: a protocol for a randomized controlled pilot trial.

BACKGROUND: Knee osteoarthritis (KOA) is one of the most common bone and joint diseases. As one of the main non-drug therapies, acupuncture is widely used to treat KOA, although the evidence for its efficacy is inconclusive. The objective of this pilot trial is to clarify the clinical efficacy and safety of fire acupuncture in the treatment of mild to moderate KOA and to provide high-quality data for further research. METHODS/DESIGN: This study is a prospective randomized controlled pilot trial in which 120 patients with mild to moderate KOA will be randomly allocated in equal proportions to a fire acupuncture group or a general acupuncture group. They will receive acupuncture for six sessions over 2 weeks. The primary end point is success rate, which will be calculated based on the change from baseline of the pain and function scores in the Western Ontario and McMaster Universities Osteoarthritis Index at 4 weeks. Secondary end points include the proportion of patients achieving clinical improvement based on: (1) the OMERACT-OARSI responder criteria, (2) levels of matrix metalloproteinase 3, interleukin 1ß, and tumor necrosis factor α in blood, and (3) a subjective efficacy evaluation from patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800019162. Registered on 29 October 2018.

Motion style acupuncture therapy for shoulder pain: a randomized controlled trial.

BACKGROUND: Strategies for preventing the persistence of pain and disability beyond the acute phase in shoulder pain patients are critically needed. Conventional acupuncture therapy (CAT) or motion style acupuncture therapy (MSAT) alone results in relative improvements in painful conditions in shoulder pain patients; combined interventions may have more global effects. The aim of this study is to evaluate the efficacy and safety of MSAT vs CAT for shoulder pain. METHODS: A randomized controlled trial using a factorial design was conducted from January 2014 to December 2015. Patients with a primary complaint of one-sided shoulder pain participated at three study sites. Eligible individuals were randomly assigned to receive MSAT plus minimal CAT (mCAT), CAT plus minimal MSAT (mMSAT), MSAT plus CAT, or mMSAT plus mCAT for 6 weeks in a 1:1:1:1 ratio. The primary outcome was change in shoulder pain intensity (measured using visual analog scale). The secondary outcomes included change in function of the shoulder joint (Constant-Murley score) and the health-related quality of life (Short Form-36 Health Survey). Moreover, perceived credibility of acupuncture was measured using the Treatment Credibility Scale. The outcomes were assessed at baseline and at 6, 10, and 18 weeks after randomization. Analysis of covariance with the baseline score adjustment had been used to determine the primary end point. The between-group differences of MSAT vs mMSAT and CAT vs mCAT were estimated, respectively, after tests of interaction between the two-dimensional interventions. All main analyses followed the intention-to-treat principle. RESULTS: A total of 164 patients completed the study. MSAT was superior to mMSAT in alleviating pain intensity at 10 weeks (P=0.024), and it was maintained for 18 weeks (P=0.013). Statistically significant differences were found when comparing MSAT with mMSAT for improvement in shoulder function (6 weeks, P=0.01; 10 weeks, P=0.006; and 18 weeks, P=0.01), physical health (10 weeks, P=0.023 and 18 weeks, P=0.015), and mental health (18 weeks, P=0.05). No significant differences were found in CAT when compared with mCAT. CONCLUSION: After 18 weeks of treatment, pain and joint functions are improved more with MSAT than with minimal motion style acupuncture or conventional acupuncture in patients with shoulder pain.