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Clinical Trials/ISRCTN44644781
ISRCTN44644781
Completed
Phase 4

Finger osteoArthritis Chondroitin Treatment Used in addition to Advice and Leaflets

Keele University0 sites380 target enrollmentNovember 18, 2016

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.

Registry
who.int
Start Date
November 18, 2016
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
All

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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