Acupuncture treatment for knee osteoarthritis
Efficacy and Safety of Acupuncture in the Treatment of Osteoarthritis of the Knee: Study Protocol for a Randomized Controlled Trial
This study is testing if acupuncture can help relieve knee pain and improve movement in people with knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Jiangxi University of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Nanchang, Jiangxi) |
| Trial ID | NCT06805188 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of acupuncture in treating knee osteoarthritis (KOA) through a single-blind, randomized controlled trial. A total of 350 patients with KOA will be randomly assigned to either an acupuncture group or a sham acupuncture group, receiving 24 treatments over an 8-week period. The study will compare various outcomes, including knee pain scores and functional assessments, to provide high-quality evidence regarding the effectiveness of acupuncture for KOA. The randomization and blinding processes are strictly implemented to ensure the integrity of the results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a confirmed diagnosis of knee osteoarthritis and moderate to severe knee pain.
Not a fit: Patients with a history of knee surgery or those who have received recent physical therapy for knee osteoarthritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option for patients suffering from knee osteoarthritis.
How similar studies have performed: Previous studies have shown mixed results regarding the efficacy of acupuncture for knee osteoarthritis, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Nanchang, Jiangxi
- Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine — Nanchang, Jiangxi, China (Recruiting)
Study contacts
- Study coordinator: Wu zenan
- Email: 2384516405@qq.com
- Phone: 13807004791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.