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/40990366Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06805188
Efficacy and Safety of Acupuncture in the Treatment of Osteoarthritis of the Knee: Protocol for a Randomized Controlled Trial
Led by Wu zenan · Updated on 2025-02-03
350
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Wu zenan
Lead Sponsor
T
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 acupuncture's 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
Brief Title
Clinical Study of Acupuncture Treatment of Knee Osteoarthritis
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, any gender
- Diagnosed with knee osteoarthritis by American College of Rheumatology criteria
- Knee pain score greater than 4 on Numerical Rating Scale lasting at least 3 months
- Diagnosis confirmed by MRI or x-ray within the last 3 years
- Willing to participate and sign informed consent
You will not qualify if you...
- History of knee surgery
- Received physical therapy for knee osteoarthritis, including corticosteroid injections, acupuncture, or moxibustion within the past 3 months
- Diseases causing knee pain such as fracture, synovial cyst, or rheumatoid arthritis
- Significant neurological injury
- Prior serious mental illness, organ failure, or cancer
- Planned knee surgery within the next 3 months
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive either real acupuncture or sham acupuncture treatments for knee osteoarthritis.
24 treatment sessions over 8 weeks
Follow-up
Duration - 16 weeks
Participants are monitored after treatment to evaluate efficacy and safety outcomes.
Visits at Week 16 and Week 24 post-treatment
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China, 330004
Actively Recruiting
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Research Team
W
Wu zenan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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