Crossbow needle therapy of the Miao ethnic minority group for knee osteoarthritis: study protocol for a randomized controlled trial

BACKGROUND: Knee osteoarthritis (KOA) is commonly seen and has a high occurrence in the middle-aged and elderly. It is characterized by the degeneration and secondary bone hyperplasia of the articular cartilage; the pathologic changes are irreversible. Therefore, treatment of KOA is mainly focused on relieving pain, reducing inflammation, improving or restoring joint function, delaying disease progression, and increasing quality of life. Crossbow needle therapy of the Miao ethnic minority group is intended for KOA treatment and has been widely used. Studies of small sample size have seen significant improvement on pain relief, stiffness, and joint function. METHODS/DESIGN: The trial is a randomized, multicenter, parallel, non-inferiority study. Three hundred and six patients will be randomly assigned to a crossbow needle group (n = 153) and an acupuncture group (n = 153). Patients in each group will receive treatment every other day, three times a week, 20 times in total. Follow-up will be conducted 15 days and 30 days after treatment. The primary outcome will be the Western Ontario and McMaster Osteoarthritis Index (WOMAC) score at baseline, the end of treatment, first follow-up, and second follow-up. The secondary outcomes will include Lysholm knee score, Japanese Orthopedic Association (JOA) knee score, visual analogue scale (VAS), and the MOS 36-item short-form health survey (SF-36). DISCUSSION: The results of the trial will compare the efficacy on KOA between crossbow needle group and acupuncture group and will be expected to make a systematic and objective evaluation of crossbow needle therapy. TRIAL REGISTRATION: ChiCTR, ChiCTR-INR-16008032. Registered on 12 March 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2730-4) contains supplementary material, which is available to authorized users.