Efficacy and Safety of Acupuncture in the Treatment of Osteoarthritis of the Knee: Study Protocol for a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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

Locations
Other Locations
China
Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
RECRUITING
Nanchang
Contact Information
Primary
Wu zenan
2384516405@qq.com
13807004791
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2026-01-05
Participants
Target number of participants: 350
Treatments
Experimental: Treatment group
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).
Placebo_comparator: Control group
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.
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Leads: Wu zenan

This content was sourced from clinicaltrials.gov