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
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
Blog Article
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, Co-Enzyme Q-10 with Carnitine 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 boys l/s rashguard 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.