Effectiveness and Safety of Polydioxanone Thread Embedding Acupuncture Compared with Acupuncture Treatment for Knee Osteoarthritis: a Protocol for a Pilot, Assessor-Blinded, Randomized Controlled Trial
Bibliographic record
Abstract
Importance: Knee osteoarthritis (OA) is a common degenerative joint disease in aging populations. Knee OA is difficult to cure and requires ongoing management. Thread embedding acupuncture (TEA) is a popular Korean medical treatment for knee OA. However, clinical evidence of its effectiveness and safety is insufficient. Objective: This study aims to evaluate the effectiveness and safety of TEA compared with acupuncture for knee OA. Design, Setting, and Population: A two-group, two-arm, parallel, single-center, randomized, controlled, and assessor-blinded pilot trial will be conducted. A total of sixty patients aged between 40 and 85 years old will be recruited. Exposures: The TEA group will receive four sessions of TEA treatment over 4 weeks. The acupuncture group will receive eight sessions of acupuncture treatment over 4 weeks. A follow-up assessment will be conducted in week 8 for both groups. Main Outcomes and Measures: Assessments will be performed at baseline, 2 weeks, 4 weeks, and 8 weeks. The primary outcome will be the mean change in the visual analog scale between the two groups at 4 weeks. The secondary outcomes will be the mean change in the Korean Western Ontario and McMaster Universities Osteoarthritis Index, knee range of motion, EuroQol 5-Dimension, patient global impression of change, and dosage of rescue medication. Statistical analysis will be conducted and the level of significance will be achieved in each variables. Results: The results will be published in a peer-reviewed journal. Conclusions and Relevance: This study provides a rationale for the effectiveness and safety of TEA for knee OA by comparing TEA treatment with acupuncture.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.011 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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; both teacher heads agree on what is shown here.
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".