Clinical Study of Acupuncture Treatment of Knee Osteoarthritis
Efficacy and Safety of Acupuncture in the Treatment of Osteoarthritis of the Knee: Study Protocol for a Randomized Controlled Trial
Wu zenan
350 participants
Feb 15, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- aged 18-70 years old, regardless of gender
- meeting the diagnostic criteria of the American College of Rheumatology (ACR) of KOA
- patients with an NRS score of at least greater than 4 for knee pain, and the pain has lasted for at least 3 months
- diagnosed with osteoarthritis of the knee by magnetic resonance imaging (MRI) or x-ray in the last 3 years
- volunteering to participate in this trial and signing informed consent
Exclusion Criteria7
- Patients with a history of knee surgery
- Patients who had received any physical therapy related to osteoarthritis of the knee, such as corticosteroid injections, acupuncture, or moxibustion, within the past 3 months
- Patients who had a disease that could lead to pain in the knee, such as a fracture, a synovial cyst, or rheumatoid arthritis
- Patients who had a history of knee surgery. or any significant neurological injury
- Prior serious mental illness, organ failure, or malignancy
- Planned knee surgery within the next 3 months
- Pregnancy or breastfeeding
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06805188