Splinting to Treat Hand Osteoarthritis (SPLINTOA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01249391
First received: November 25, 2010
Last updated: November 26, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Hand Osteoarthritis
Device: Splinting
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Splinting to Treat Interphalangeal Joint Deformity in Hand Osteoarthritis(Splint OA Study)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Pain in nominated joint [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assessed via numerical rating scale


Secondary Outcome Measures:
  • Radiological deviation of nominated joint [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Degrees of radial or ulnar deviation of joint will be assessed radiographically.


Estimated Enrollment: 45
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249391

Contacts
Contact: Fiona Watt 208 3834444 f.watt@imperial.ac.uk

Locations
United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Fiona Watt    44 2083834444    f.watt@imperial.ac.uk   
Principal Investigator: Fiona Watt         
Sponsors and Collaborators
Imperial College London
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Fiona Watt Imperial College London
  More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01249391     History of Changes
Other Study ID Numbers: JROHH051
Study First Received: November 25, 2010
Last Updated: November 26, 2010
Health Authority: UK: NRES

Keywords provided by Imperial College London:
Hand osteoarthritis interphalangeal splint pain deformity deviation function

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014