JMIR Publications

ABSTRACT

Background:

Knee osteoarthritis (KOA) is a highly prevalent osteoarticular disease lacking effective specific therapies. While acupuncture is increasingly employed clinically for KOA management, its efficacy requires further optimization.

Objective:

This randomized trial aims to evaluate the efficacy and safety of acupuncture applied to sensitized acupoints for KOA through a randomized trial.

Methods:

This randomized, single-blind, sham-controlled trial will enroll 350 KOA patients with baseline pain intensity ≥ 4 on the Numeric Rating Scale (NRS) from three clinical centers. Participants will be randomly allocated (1:1) to receive either acupuncture or sham acupuncture. The acupuncture group will receive acupuncture treatment at five high-probability sensitized acupoints on the affected side: Chize (LU5), Quchi (LI11), Dubi (ST35), Fengshi (GB31), and Xiyangguan (GB33), with manual needle manipulation for 30 seconds followed by 30-minute retention. The sham acupuncture group will undergo non-penetrative needling using Takakura acupuncture simulation devices at identical acupoints with matched manipulation duration and retention time. Both groups will receive a total of 24 sessions over 8 weeks, followed by a 16-week no-treatment extension follow-up. Block randomization sequences will be generated using R software by an independent randomization center, with allocation concealment maintained through sealed opaque envelopes. Strict blinding will be implemented for participants, outcome assessors, and statisticians. The primary outcome is the proportion of responders defined as a reduction of at least 2 points in the NRS score at week 8. Secondary outcomes include changes from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index score, 40-meter fast walking test result, Roland-Morris Disability Questionnaire score, Hamilton Depression Rating Scale score, Hamilton Anxiety Rating Scale score, Insomnia Severity Index score, and Pain Self-Efficacy Questionnaire score. All adverse events will be systematically documented for safety evaluation. Efficacy analysis will adhere to the modified intention-to-treat principle, including all patients receiving at least one trial intervention with at least one post-baseline NRS assessment. Missing data will be imputed using multiple imputation methods.

Results:

This study is funded by the scientific and technological research project of Jiangxi Provincial Department of Education (GJJ2400805) and was registered in January 2025 (ClinicalTrials.gov, No. NCT06805188). Participant recruitment is scheduled to begin in June 2025, and by August 2025, we expect to have enrolled 350 participants. It is currently in the patient recruitment phase. Final data collection is expected to be completed by March 2026 and results will be available in the fall of 2026.

Conclusions:

The expected results suggest that the true acupuncture group was able to effectively treat KOA through acupuncture point sensitization compared to the sham acupuncture group.If the results of the study are validated, we hope to establish acupuncture point sensitization-based acupuncture as the treatment of choice for KOA, leading to a reduction in medication dependence, mitigation of medication-related adverse effects and ultimately an improvement in the quality of life of the affected population. Clinical Trial: ClinicalTrials.gov, No. NCT06805188.