Splinting to Treat Hand Osteoarthritis | Completed
Splinting to Treat Hand Osteoarthri... | Completed
Splinting to Treat Hand Osteoarthritis
SPLINTOA
Trial Source

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Medical Conditions
  • Hand Osteoarthritis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01249391
Primary Trial ID Number

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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.
Research Details
    Sorry, this information is not available
Phase
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
Interventional
Intervention
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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - 90 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
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. 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
London
Greater London
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Splinting to Treat Interphalangeal Joint Deformity in Hand Osteoarthritis(Splint OA Study)
EudraCT Number
Not available for this trial
Funder(s)
  • National Institute for Health Research, United Kingdom
Other Study ID Numbers
JROHH051
Sponsor(s)
Imperial College London
Key Dates

Recruitment Start Date

Sep 2010

Recruitment End Date

Sep 2011

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

25 Nov 2010

Date updated in source

15 Feb 2016