Using melatonin to relieve knee pain in osteoarthritis patients

Efficacy and Safety of Melatonin for Pain Relief in Knee Osteoarthritis Patients: A Randomized, Double-Blind, Placebo-Controlled Trial

This study is testing if melatonin can help relieve knee pain in people aged 40 to 80 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: NCT06012175 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of melatonin in alleviating pain for patients suffering from knee osteoarthritis (KOA). The study will recruit participants aged 40 to 80 who meet specific criteria for KOA and will be randomized to receive either melatonin or a placebo for 12 weeks. The trial is designed as a double-blind, placebo-controlled study to ensure unbiased results. The findings could provide insights into a novel treatment option for managing pain in KOA patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 40 to 80 with a diagnosis of knee osteoarthritis and significant pain lasting at least three months.

Not a fit: Patients with recent use of NSAIDs, corticosteroids, or those who have undergone knee surgery in the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new, effective treatment option for managing pain in knee osteoarthritis patients.

How similar studies have performed: While there is limited high-quality clinical evidence specifically for melatonin in osteoarthritis, previous studies have shown its analgesic benefits in other chronic pain conditions.

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 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 cardiopulmonary diseases.
9. Uncontrolled hypertension or diabetes mellitus.
10. Diagnosis of malignant tumors.
11. Pregnant or contemplating pregnancy or breastfeeding.
12. Any use of melatonin supplement before enrollment within 30 days.
13. Allergic to melatonin or its preparation.
14. Any use of anti-depressive/psychotropic drugs.

Where this trial is running

Changsha, Hunan

• Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Chao Zeng, MD, PhD — Xiangya Hospital of Central South University
• Study coordinator: Dongxing Xie, MD, PhD

Conditions Osteoarthritis, Knee; Osteoarthritis; Melatonin; Pain