Using L-arginine to relieve knee osteoarthritis pain

Efficacy and Safety of Oral L-Arginine for Pain Relief in Knee Osteoarthritis: a Randomized, Double-Blind, Placebo-Controlled Trial

This study is testing if L-arginine, a nutritional supplement, can help relieve knee pain for people with osteoarthritis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 340 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (Academic / other)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06054633 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of L-arginine, an oral nutritional supplement, in alleviating pain for patients suffering from knee osteoarthritis (KOA). The research will be conducted as a randomized, double-blind, placebo-controlled trial, comparing the effects of L-arginine tablets against placebo tablets. The study aims to address the urgent need for safe pain management options in KOA patients, given the safety concerns associated with commonly prescribed analgesics. Previous studies suggest that L-arginine may play a role in reducing pain symptoms in KOA, but high-quality clinical evidence is lacking.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 80 with knee osteoarthritis and significant pain lasting at least three months.

Not a fit: Patients who have used NSAIDs or other analgesics recently, or those with certain knee conditions or surgeries, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer alternative for pain relief in knee osteoarthritis patients.

How similar studies have performed: While previous studies have indicated potential benefits of L-arginine in related conditions, this specific approach in knee osteoarthritis is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age between 40 and 80 years.
2. Knee OA according to the American College of Rheumatology (ACR) clinical criteria.
3. Knee pain lasting 3 months or longer and a score of 7 or greater on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (standardized to range from 0-20).
4. Kellgren-Lawrence (KL) grade 2 or 3.
5. Willing to and able to provide written informed consent.

Exclusion Criteria:

1. Any use of NSAIDs or other analgesics in the past two weeks.
2. History of injections of corticosteroids in the past three months or hyaluronic acid in the past 6 months in the index knee.
3. History of arthroscopy or open surgery in the index knee in the past 12 months.
4. History of a knee replacement in the index knee or planning to receive such a procedure within 3 months.
5. History of a severe injury in the index knee.
6. Pain in the index knee caused by inflammatory, autoimmune, neoplastic diseases or other diseases.
7. Abnormal liver or kidney functions, as defined by alanine transaminase or aspartate aminotransferase \>two times the upper limit of normal, or blood urea nitrogen or serum creatinine \>two times the upper limit of normal.
8. Severe respiratory diseases.
9. History of coronary artery disease and heart failure.
10. Uncontrolled hypertension or diabetes mellitus.
11. Diagnosis of malignant tumors.
12. Pregnant or contemplating pregnancy or breast-feeding.

Where this trial is running

Changsha, Hunan

• Xiangya Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Guanghua Lei, MD, PhD — Xiangya Hospital of Central South University
• Study coordinator: Yilun Wang, MD, PhD

Conditions Osteoarthritis, Knee; osteoarthritis; L-arginine; Pain