Efficacy and Safety of Acupuncture at Sensitized Acupoints for Knee Osteoarthritis: Protocol for a Multicenter, Single-Blind Randomized Controlled Trial.
Zenan Wu, Zehao Hu, Zixuan Xu...
https://pubmed.ncbi.nlm.nih.gov/40990366/Actively Recruiting
Led by Wu zenan · Updated on 2025-02-03
350
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effects and safety of acupuncture for treating knee osteoarthritis KOA, a common joint disease with limited effective treatments. This study uses a single-blind, randomized controlled trial design involving 350 patients to provide strong evidence on acupunctures impact compared to sham acupuncture for KOA symptoms and mental health. Participants are randomly assigned to one of two groups the acupuncture group receiving real needling at specific acupoints, and the sham acupuncture group receiving a simulated treatment with a device that mimics needling without penetrating the skin. Both groups undergo 24 treatment sessions over eight weeks, with treatments performed by experienced licensed acupuncturists following standardized procedures. During the study, participants will be assessed multiple times up to 24 weeks after starting treatment using measures like the Numerical Rating Scale for pain, WOMAC index, walking tests, and mental health questionnaires. Researchers will monitor safety by recording any adverse events. The trial includes follow-up assessments at weeks 4, 8, 16, and 24 to evaluate changes in pain, function, mental health, sleep quality, and pain self-efficacy.
CONDITIONS
Clinical Study of Acupuncture Treatment of Knee Osteoarthritis
W
Wu zenan
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Wu zenan
Lead Sponsor
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Collaborating Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either real acupuncture or sham acupuncture treatments for knee osteoarthritis.
24 treatment sessions over 8 weeks
Duration - 16 weeks
Participants are monitored after treatment to evaluate efficacy and safety outcomes.
Visits at Week 16 and Week 24 post-treatment
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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Zenan Wu, Zehao Hu, Zixuan Xu...
https://pubmed.ncbi.nlm.nih.gov/40990366/Wu zenan
Lead Sponsor
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Collaborating Sponsor