Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial

Abstract

Background Knee osteoarthritis (KOA) is one of the most common musculoskeletal disorders. Acupotomy may be effective for KOA, but the evidence is limited. This trial aims to determine the effectiveness and safety of acupotomy for KOA. Methods/design This is a parallel-group, assessor-blinded randomized controlled trial. Two hundred patients with KOA will be recruited and randomly assigned to two groups (group A or group D) in a 1:1 ratio. Patients in group A will receive acupotomy and topical diclofenac diethylamine for 4 weeks, while patients in group D will receive topical diclofenac diethylamine alone for 4 weeks. The primary outcome will be the response rate—the proportion of patients who achieve the minimal clinically important improvement in pain and function at week 4 compared with baseline. Secondary outcomes will include pain, function, quality of life, the use of rescue medicine (loxoprofen sodium), and adverse events at weeks 4, 8, and 24 after randomization. Besides, joint fluid and serum will be collected to assess the level of inflammatory cytokines, like TNF-α, IL-1β, and MMP-3. Discussion This study will contribute to a better understanding of the effectiveness and safety of acupotomy in combination with topical nonsteroidal anti-inflammatory drugs. If the hypothesis is confirmed, acupotomy may be recommended as adjunctive therapy for patients with KOA. Results of the study will be of great importance for the guidelines of clinical therapy. Trial registration Chinese Clinical Trial Registry ChiCTR2100043005 Registered on 4 February 2021.

Effects of externally-applied, non-pharmacological Interventions on short- and long-term symptoms and inflammatory cytokine levels in patients with knee osteoarthritis: a systematic review and network meta-analysis

“…This finding indicated that the immediate analgesic effect of the drug was better and the long-term effect was worse, which is consistent with the above follow-up ranking results. In terms of WOMAC function, the comparison between the <4-week and ≥4-week subgroups showed OT lost its ranking advantage over AT and LT, which may be related to the slow onset of AT and LT ( 120 ).…”

Acupotomy Improves Synovial Hypoxia, Synovitis and Angiogenesis in KOA Rabbits

“…Acupotomy therapy is a minimally invasive therapy of traditional Chinese medicine, which combined both traditional acupuncture and modern surgical principles, and could dredge meridians and release tissue adhesion because of the specific bit tool of acupotomy could needle, cut, strip, and shove. 25 Acupotomy has been shown to be beneficial in the treatment of KOA in clinical trials, and it is simple, inexpensive, effective, and safe. 26 Biomechanical factors are currently recognized as the pathogenesis of KOA.…”

Deep Learning-Based CT Imaging to Evaluate the Therapeutic Effects of Acupuncture and Moxibustion Therapy on Knee Osteoarthritis

“…Studies have shown that it starts from the degenerative changes of knee articular cartilage, gradually affects the subchondral plate and joint capsule, and finally leads to the progressive destruction of articular cartilage and synovial inflammation [ 12 ]. Patients with KOA always have clinical symptoms such as joint pain, swelling, and mobility impairment [ 13 – 15 ]. KOA is classified as joint pain in traditional Chinese medicine.…”