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Randomized Controlled Trial
. 2020 Sep 4;99(36):e21957.
doi: 10.1097/MD.0000000000021957.

Efficacy and safety of thread embedding acupuncture on knee osteoarthritis: A randomized, controlled, pilot clinical trial

Affiliations
Randomized Controlled Trial

Efficacy and safety of thread embedding acupuncture on knee osteoarthritis: A randomized, controlled, pilot clinical trial

Purumea Jun et al. Medicine (Baltimore). .

Abstract

Introduction: Although there are various therapeutic methods for the treatment of knee osteoarthritis, each has its advantages and shortcomings, and a definitive treatment method is yet to be determined. This pilot study is designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of thread embedding acupuncture (TEA) with polydioxanone thread in knee osteoarthritis patients.

Methods and analysis: This study is a clinical trial to evaluate the efficacy and safety of TEA for knee osteoarthritis. Forty participants will be recruited at the hospital and after randomization into 2 groups of 20 (experimental and control); they will be treated for 6 weeks. The experimental group will receive TEA treatment 6 times (1 time/week) in 6 weeks on 14 defined knee areas, and the control group, acupuncture treatments 12 times (2 times/week) in 6 weeks on 9 defined acupuncture points. The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment. The follow-ups before clinical trial, 3 weeks after procedure, 6 weeks after procedure, and 4 weeks after the end of procedure will be done to compare the degree of pain with the control group, which received the acupuncture treatment.

Conclusion: The trial based on this study will provide clinical information on the efficacy and safety of TEA treatment on knee osteoarthritis.

Trial registration number: KCT0004844.

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Conflict of interest statement

None of the authors declares any conflicts of interest.

Figures

Figure 1
Figure 1
Study flow chart.
Figure 2
Figure 2
TEA used in clinical trial.
Figure 3
Figure 3
The point of TEA.

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