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.

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.