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

Phase 4

Completed

• Conditions: Osteoarthritis of the hand; Musculoskeletal Diseases

• Registration Number: ISRCTN44644781
• Lead Sponsor: Keele University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-18
• Last Update Posted: 27 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 380

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain severity in the previous 2 weeks, measured using a 0-10 Numerical Rating Scale (NRS) at 0, 3, 6, 9 and 12 months