Clinical Study of Acupuncture Treatment of Knee Osteoarthritis
NCT06805188 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2025-02-03
Summary
The main question of this study was to evaluate the efficacy and safety of acupuncture in the treatment of knee osteoarthritis (KOA) through a single-blind, randomized controlled trial divided into two groups. Patients in both groups received a total of 24 acupuncture treatments over an 8-week period. The differences in knee NRS score, WOMAC index, walking test, mental health assessment and other indicators between the acupuncture group and the sham acupuncture group before and after treatment were compared to provide high-quality evidence to support the effectiveness of acupuncture in treating KOA.
Conditions
- Osteoarthritis of the Knees
- Osteoarthritis (OA) of the Knee
- Osteoarthritis
Interventions
- OTHER
-
Acupuncture
The intervention was performed by two licensed acupuncturists with at least 10 years of clinical experience who received two weeks of training in standardized intervention methods prior to the trial. Acupoints location refers to the WHO Standard Acupuncture Point Locations in the Western Pacific Region (WHO Standard)〔41〕.The acupuncture group will receive the following acupoints (Figure 3, Table 2): the affected side of Chize(LU5), Quchi (LI11), Dubi (ST35), Fengshi (GB31), and Xiyangguan (GB33). Needling was performed with 0.30mm x 40mm disposable Huatuo brand sterile acupuncture needles.After the needles were inserted, needle manipulation was performed at all acupuncture points to achieve the sensations of soreness, numbness, distension, and heaviness.Each acupoint was manipulated for about 30 seconds, and the acupuncture treatment was performed for one 30-minute session.
- OTHER
-
Sham acupuncture
The device's sham needling operation mimics real needling through appearance and tactile sensation, making it difficult for patients to distinguish, meeting the requirement of blinding and effectively controlling the patients' cognitive bias towards the type of intervention. Patients in the sham acupuncture group received this sham acupuncture intervention, which was designed to ensure that only the actual biological effects of acupuncture differed between the experimental group and the control group, and to exclude the psychological implication effects caused by the patients' expectation effects or the operation itself, so as to enhance the scientific validity and reliability of the research results.
Sponsors & Collaborators
-
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
collaborator OTHER -
Wu zenan
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-15
- Primary Completion
- 2026-01-05
- Completion
- 2026-01-05
Countries
- China
Study Locations
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