Efficacy and Safety of Acupuncture at Sensitized Acupoints for Knee Osteoarthritis: Protocol for a Multicenter, Single-Blind Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: 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. OBJECTIVE: This trial aims to evaluate the efficacy and safety of acupuncture at sensitized acupoints for the treatment of KOA. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT06805188; https://clinicaltrials.gov/study/NCT06805188. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77336.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.037 | 0.033 |
| Meta-epidemiology (narrow) | 0.008 | 0.003 |
| Meta-epidemiology (broad) | 0.013 | 0.005 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.004 | 0.005 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.008 | 0.009 |
| Insufficient payload (model declined to judge) | 0.051 | 0.010 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".