Sinew acupuncture for knee osteoarthritis: study protocol for a randomized sham-controlled trial.

BACKGROUND: Sinew acupuncture is a new modality of acupuncture in which needles are inserted into acupoints, ashi points or spasm points of sinew and muscles along the meridian sinew pathway. A previous observational study revealed that sinew acupuncture has immediate analgesic effects on various soft tissue injuries, including knee injuries. However, no rigorous trials have been conducted. This study aims to examine whether sinew acupuncture can safely relieve pain and symptoms of knee osteoarthritis (KOA) and improve patients' functional movement and quality of life. METHODS/DESIGN: A randomized, sham-controlled, patient- and assessor-blinded trial will be conducted to compare the efficacy of sinew acupuncture and sham acupuncture. Subjects will be assessed by the physician and acupuncturists. A sample of eighty-six eligible subjects will be randomized into either the sinew acupuncture group or the sham acupuncture group. The intervention will be performed in the Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of the University of Hong Kong by acupuncturists with over 3 years of acupuncture experience. Subjects will receive 10 sessions of interventions for 4 weeks, followed by a 6-week follow-up. The visual analogue scale (VAS) score at week 4 will be the primary outcome. The Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed Up & Go Test (TUG), 8-step Stair Climb Test (SCT) and the 36-Item Short Form Survey (SF-36) will be secondary outcomes. DISCUSSION: Sinew acupuncture is a potential alternative non-pharmacological therapy for KOA. This rigorous trial will expand our knowledge of whether sinew acupuncture reduces pain intensity and improves symptoms, functional movements, and quality of life of KOA patients. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (Identifier: NCT03099317) in March 2017.

Superficial Needling Acupuncture vs Sham Acupuncture for Knee Osteoarthritis: A Randomized Controlled Trial.

BACKGROUND: Acupuncture has been an alternative approach for pain management, but trial evidence is conflicting. METHODS: Eighty-six patients with knee osteoarthritis were randomly assigned in a 1:1 ratio from June 14, 2017, to January 20, 2019, to receive either superficial needling acupuncture treatment or sham acupuncture for 10 sessions over a 4-week treatment period, followed by a 6-week follow-up period. The primary outcome was the change of pain intensity at week 4 measured using a 100-mm visual analogue scale. Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index and 36-Item Short Form Health Survey. RESULTS: At the end of the 4-week treatment period, mean changes in the visual analogue scale were -30.8 (95% confidence interval [CI], -38.2 to -23.0; p <.001) in the acupuncture group and -26.7 (95% CI, -34.4 to -18.8; P <.001) in the sham group. The difference between the acupuncture group and the sham group was -4.1 (95% CI, -14.4 to 6.2; P = 0.431). At week 10, the difference between the groups was -2.2 (95% CI, -13.1 to 8.8; P =0.699). There was no statistically significant difference in Western Ontario and McMaster Universities Osteoarthritis Index subscores (pain, stiffness, and physical function) and 36-Item Short Form Health Survey-related outcomes across groups from weeks 2 to 10. The incidence of treatment-related adverse events was 4.4% in the acupuncture group and 0.8% in the sham acupuncture group. All adverse events were classified as mild. CONCLUSION: Acupuncture for 4 weeks is not superior to non-penetrating sham acupuncture. The current study cannot confirm that superficial acupuncture has efficacy for the treatment of knee osteoarthritis.