Efficacy and Safety of Acupuncture at Sensitized Acupoints for Knee Osteoarthritis: Protocol for a Multicenter,...

Knee osteoarthritis (KOA) is a prevalent osteoarthritic disorder. Although acupuncture is increasingly used in clinical practice for KOA management, its efficacy remains to be further optimized.

This trial aims to evaluate the efficacy and safety of acupuncture at sensitized acupoints for the treatment of KOA.

We will recruit 350 patients diagnosed with KOA from 3 clinical centers in this single-blind, sham-controlled, randomized controlled trial. Participants will be randomized to receive either acupuncture at 5 high-probability sensitized acupoints or sham acupuncture with nonpenetrative needling using Takakura acupuncture simulation devices. Both groups will receive 24 sessions over 8 weeks, followed by a 16-week posttreatment follow-up period. The primary outcome is the proportion of responders, defined as a reduction of 2 or more points in the Numeric Rating Scale score at week 8. Secondary outcomes include changes in scores on validated scales for KOA severity, walking distance, disability, depression, anxiety, insomnia, and pain self-efficacy. Adverse events will be documented for safety evaluation.

The first participant was enrolled on February 15, 2025, and by June 28, 2025, we had enrolled 25 patients. Data analysis has not yet been initiated. The completion of data collection is anticipated by March 2026.

This trial aims to provide confirmatory and exploratory evidence regarding the efficacy and safety of sensitized acupoint-based acupuncture for treating KOA. If the hypothesized benefits are substantiated, sensitized acupoint-based acupuncture could emerge as a complementary and alternative therapy for KOA, potentially reducing reliance on medication and mitigating drug-related adverse effects.

ClinicalTrials.gov NCT06805188; https://clinicaltrials.gov/study/NCT06805188.

DERR1-10.2196/77336.