Splinting to Treat Hand Osteoarthritis (SPLINTOA)
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|ClinicalTrials.gov Identifier: NCT01249391|
Recruitment Status : Completed
First Posted : November 29, 2010
Last Update Posted : February 17, 2016
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 (IPJs) 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.
|Condition or disease||Intervention/treatment||Phase|
|Hand Osteoarthritis||Device: Splinting||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Splinting to Treat Interphalangeal Joint Deformity in Hand Osteoarthritis(Splint OA Study)|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2011|
Active Comparator: Intervention (splinting)
Splinting of nominated joint in this group
Gutter thermoplastic custom-made splint for nominated joint, to be worn at night-time for consecutive nights for 3 months
No Intervention: Control
Observation and usual treatment only.
- Pain in nominated joint [ Time Frame: 3 months ]Assessed via numerical rating scale
- Radiological deviation of nominated joint [ Time Frame: 3 months ]Degrees of radial or ulnar deviation of joint will be assessed radiographically.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249391
|Imperial College Healthcare NHS Trust|
|London, United Kingdom|
|Principal Investigator:||Fiona Watt||Imperial College London|