Splinting to Treat Hand Osteoarthritis | Recruiting
Splinting to Treat Hand Osteoarthritis
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Hand Osteoarthritis
Primary Contact Details
Recruitment Status
Primary Trial ID Number
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, progressive loss of hand function and deformity. Deviation, or bending to the side, of IP joints with significant functional and cosmetic consequences for the individual is common. There are no drugs which can slow the disease process so there is reliance on symptomatic treatment such as pain relief and hand therapy. Joint thermoplastic splinting (moulded plastic splints that are custom-made) is employed by hand therapists in other settings, but to the investigators knowledge no studies have formally investigated the effect of splinting in IP OA. By resting inflamed tissues and correcting joint alignment, a beneficial role for splinting in IP OA is likely. In this study, the investigators want to test whether thermoplastic splinting of deviated IP joints due to OA will 1) improve joint alignment 2) ameliorate soft tissue inflammation, and whether as a consequence 3) pain and overall hand function will be improved. Adults with hand OA with 'affected' IP joints (symptoms from OA associated with deviation of the joint on X-ray)will be recruited from a specialist hand osteoarthritis clinic. Initially this will be for distal IP (DIP) joints. In the intervention group (30 patients), an 'intervention' joint for splinting will be identified as the most painful deviated DIP joint in the past week leading up to enrolment. Up to 3 other 'affected' DIP joints on either hand will not be splinted but will be monitored as 'control' joints. In the control group (15 patients), an affected joint will be monitored but not splinted. Assessment of joint pain, hand function by a hand therapist, deformity (by X-ray)and joint inflammation will take place at baseline, during and at the end of splinting period of 3 months, and also at 6 months,to assess whether any changes are persistent. In this way, the efficacy of splinting of IP joints in OA will be assessed.
Research Details
    Sorry, this information is not available
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Study Type
Device : Splinting

Study Arm Groups : Intervention (splinting)

Intervention Type
See Interventions above
Primary Outcome Measures
  • Pain in nominated joint; 3 months
Secondary Outcome Measures
  • Radiological deviation of nominated joint; 3 months
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Age Range
18 Years - 90 Years
Who Can Participate
Number of Participants
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - 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. NSAIDs
  • - Capable of providing written informed consent
  • Exclusion Criteria:
  • - 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Trial Contact(s)
Primary Trial Contact
Fiona Watt
208 3834444
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Splinting to Treat Interphalangeal Joint Deformity in Hand Osteoarthritis(Splint OA Study)
EudraCT Number
Not available for this trial
  • National Institute for Health Research, United Kingdom
Other Study ID Numbers
Imperial College London
Key Dates

Recruitment Start Date

Sep 2010

Recruitment End Date

Jun 2011

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

25 Nov 2010

Last Updated

26 Nov 2010