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Splinting to Treat Hand Osteoarthritis (SPLINTOA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01249391
Recruitment Status : Completed
First Posted : November 29, 2010
Last Update Posted : February 17, 2016
National Institute for Health Research, United Kingdom
Information provided by:
Imperial College London

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, 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Intervention (splinting)
Splinting of nominated joint in this group
Device: Splinting
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.

Primary Outcome Measures :
  1. Pain in nominated joint [ Time Frame: 3 months ]
    Assessed via numerical rating scale

Secondary Outcome Measures :
  1. Radiological deviation of nominated joint [ Time Frame: 3 months ]
    Degrees of radial or ulnar deviation of joint will be assessed radiographically.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. non steroidal anti-inflammatory drugs (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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01249391

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United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
National Institute for Health Research, United Kingdom
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Principal Investigator: Fiona Watt Imperial College London
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Imperial College London Identifier: NCT01249391    
Other Study ID Numbers: JROHH051
First Posted: November 29, 2010    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: July 2011
Keywords provided by Imperial College London:
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases