Knee Osteoarthritis
Conditions
Keywords
Osteoarthritis, Knee, Resveratrol, Oral Treatment, Pain, Trial
Brief summary
The purpose of this study is to determine whether resveratrol is effective in the treatment of painful knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is the first cause of handicap in individuals over 40 years-old in France. OA physiopathology is driven in part by local joint inflammation responsible for pain and joint destruction. Experimental studies have shown that resveratrol, a molecule antagonist to the aryl hydrocarbon receptor, has anti-inflammatory and chondroprotective properties in vitro and in vivo. The investigators hypothesize that oral resveratrol, in a new formulation improving its bioavailability, could reduce knee pain at 3 months as compared with placebo in people with knee OA.
Interventions
DRUGoral resveratrol
Resveratrol will be administered orally, at the dose of 40 mg (2 caplets) twice a day for one week, then at the dose of 20 mg (1 caplet) twice a day, for a total duration of 6 months.
DRUGoral placebo
Placebo will be administered orally : 2 caplets twice a day for one week, then 1 caplet twice a day, for a total duration of 6 months
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 40 years-old * Knee osteoarthritis fulfilling 1986 American College of Rheumatology (ACR) criteria * Pain on numeric rating scale ≥ 40/100 * Symptom duration ≥ 1 month * Kellgren and Lawrence X-Ray score 1, 2 or 3 * Written consent obtained * Health insurance cover
Exclusion criteria
* History of symptomatic crystal or inflammatory arthritis * Knee surgery ≤ 1 year * Knee trauma ≤ 2 months * Knee intra-articular injections of corticosteroids and/or hyaluronic acid ≤ 2 months * Neurologic disorders involving the lower limbs * Patient not understanding and not speaking french * Participation in another biomedical research * Contraindication to resveratrol or hypersensitivity to any of its constituents * Current use of intramuscular, intravenous or oral corticosteroids * Uncontrolled diseases that may require intramuscular, intravenous or oral corticosteroids * Current use of anticoagulants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in knee pain in the previous 48 hours | at 3 months | Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in knee pain in the previous 48 hours | at 6 months | Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain |
| Mean change from baseline in specific activity limitation | at 3 months | Using self-administered WOMAC function subscore, with 0 = no |
| Mean change from baseline in patient's global assessment | at 3 months | Using a self-administered 11-point global assessment numeric rating scale, with 0 = worst possible and 100 = best possible |
| Proportion of OARSI-OMERACT responders | at 3 months | OARSI-OMERACT response |
| Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact | at 3 months | using self-reporting |
| Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact | at 3 months | using a self-administered 4-class scale (never, several times a month, several times a week, daily) |
| Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact | at 3 months | using a self-administered 4-class scale (never, several times a month, several times a week, daily) |
Countries
France
Contacts
STUDY_DIRECTORChristelle NGUYEN, MD, PhD
Université Paris Descartes, PRES Sorbonne Paris Cité
Outcome results
None listed