Chondroitin sulphate for hand osteoarthritis: a randomised, placebo-controlled trial in primary care

INTERVENTION: Participants are randomised to one of two treatment groups via a web‐based database: 1. Highly purified chondroitin sulphate 1200mg (3 x 400mg capsules) daily, oral, taken once per day for 2 years; plus usual care 2. Matching placebo 1200mg (3 x 400mg capsules) daily, oral, taken once per day for 2 years; plus usual care Any benefits of chondroitin sulphate may take weeks or months to emerge and so information is gathered from participants via postal questionnaires and telephone calls from a research nurse on seven occasions over a 2‐year period. The calls are also an opportunity to check on how participants are getting on with their treatment and to support their involvement in the study. The focus is on the severity of hand pain over the first year, but changes in difficulties with daily activities due to the hand problem, possible side effects, other treatments, and general health are also assessed. Participants are invited to attend assessment clinics at the start of the study and at 1 and 2 years to test their hand strength. Hand x‐rays are taken at the start of the study and after two years to find out whether chondroitin sulphate slows down the disease process. CONDITION: Osteoarthritis of the hand ; Musculoskeletal Diseases PRIMARY OUTCOME: Pain severity in the previous 2 weeks, measured using a 0‐10 Numerical Rating Scale (NRS) at 0, 3, 6, 9 and 12 months SECONDARY OUTCOME: 1. Secondary clinical effectiveness outcomes:; 1.1. Severity and frequency of patient‐reported hand pain and other hand symptoms, measured using AUSCAN, ACR criteria at 0, 3, 6, 9, 12 and 24 months; 1.2. Patient‐reported hand function, measured using FIHOA and AUSCAN at 0, 3, 6, 12 and 24 months; 1.3. Patient global rating of change in hand problem and other composite outcomes, measured using global improvement measure, OMERACT‐OARSI at 3, 6, 12 and 24 months; 1.4. Performance‐based measures of hand function, measured using GAT and grip/pinch strength measures at 0, 12 and 24 months; 1.5. Pain at other joint sites, measured using 0‐10 NRS at 0, 3, 6, 12 and 24 months; 1.6. Patient‐reported general health, measured using SF‐12 v2 at 0, 12 and 24 months; 1.7. Patient‐reported mood, measured using HADS at 0, 12 and 24 months; 1.8. (Serious) adverse events, measured at 1, 3, 6, 9, 12, 18 and 24 months; 2. Cost‐effectiveness, measured using EuroQoL 5D‐5L, self‐report cost data at 0, 3, 6, 12 and 24 months; 3. Structural disease progression of hand OA, measured using summed score for finger joints (DIP, PIP, thumb IP) Kallman (0‐180), summed score for finger and thumb joints (DIP, PIP, thumb IP, CMC, TS across both hands) (0‐208), summed score for base of thumb joints (CMC, TS) (0‐28), mean score per feature, mean score per joint group per feature, bilateral hand radiographs, at 0 and 24 months INCLUSION CRITERIA: 1. Aged 50 years and over 2. Fulfilling the American College of Rheumatology (ACR) definition of symptomatic hand OA 3. Hand pain =4/10 NRS in at least one hand 4. Hand pain is present on some, most or all days in the past month 5. Able to have bilateral hand radiographs 6. Stable medicines/treatment regime for pain 7. Ability to understand and capable of giving written informed consent