Osteoarthritis of the hand Musculoskeletal Diseases
Conditions
Interventions
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
Sponsors
Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Red flags e.g. history of serious illness or disease (e.g. stroke), progressive neurological signs, acute swollen joint; fractures or significant injury or surgery to the wrist or hand in the last 3 months 2. Inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis) 3. Previous use of chondroitin sulphate – ever*/within last 3 months (*subject to internal pilot) 4. Recent (past 3 months) use of steroids (oral, intra-muscular or intra-articular) 5. Recent (past 3 months) use of glucosamine sulphate/hydrochloride 6. Recent (past 3 months) plain x-rays of the hand(s) 7. Contra-indications to the trial medication (significant hypersensitivity to the active ingredient or to any of the excipients; pregnancy or breastfeeding) 8. Isolated thumb base (carpometacarpal joint) OA 9. Severe comorbidities (severe liver disease, uncontrolled asthma, severe renal disease, congestive cardiac failure, malignancy, known clotting disorders, anticoagulants) 10. Vulnerable individuals (e.g. psychiatric illness, learning difficulties, dementia, terminal illness and severe enduring mental ill health) 11. Known diagnosis of HIV or hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Contacts
Public ContactKendra Cooke
Outcome results
None listed