Status:
COMPLETED
Splinting to Treat Hand Osteoarthritis
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Hand Osteoarthritis
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
Osteoarthritis (OA) is the most common form of arthritis and the hand is the most frequently affected site.Interphalangeal (IP) joints (the small joints of the fingers) are often involved causing pain...
Eligibility Criteria
Inclusion
- Aged 18 - 90
- Definite diagnosis of IPJ osteoarthritis (American College of Rheumatology criteria for OA)
- A previous radiograph of the hands with changes consistent with OA
- Either, Intervention group: At least 2 'affected' IPJs (symptomatic (\>2/10 average pain on 0-10 scale in past week) and radiological OA associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on Xray)
- OR Control group: At least 1 'affected' IPJ (symptomatic (\>2/10 average pain on 0-10 scale in past week) and radiological OA associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on X-ray)
- Stable oral therapy for month prior to study entry e.g. non steroidal anti-inflammatory drugs (NSAIDs)
- Capable of providing written informed consent
Exclusion
- Contraindication to splinting e.g. allergy to materials
- Planned surgery during study period
- Oral, intramuscular or intraarticular steroids within 3 months of study entry
- Intraarticular hyaluronans to any nominated IP joints within 6 months of study entry
- Not resident in UK
- Pregnancy
- Other inflammatory arthritis
- History of psoriasis
- Participation in other intervention trials
- Patients with any uncontrolled or severe medical problems which in the opinion of the investigator makes them unsuitable for study participation
- Unable to give informed written consent in English
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01249391
Start Date
September 1 2010
End Date
December 1 2011
Last Update
February 17 2016
Active Locations (1)
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1
Imperial College Healthcare NHS Trust
London, United Kingdom