ISRCTN44644781
Completed
Phase 4
Finger osteoArthritis Chondroitin Treatment Used in addition to Advice and Leaflets
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Keele University
- Enrollment
- 380
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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