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Health Condition(s) or Problem
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Hand Osteoarthritis
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Device; Splinting; Gutter thermoplastic custom-made splint for nominated joint, to be worn at night-time for consecutive nights for 3 months; Intervention (splinting)
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Primary aim
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Pain in nominated joint
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Secondary Aim
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Radiological deviation of nominated joint; 3 months; No; Degrees of radial or ulnar deviation of joint will be assessed radiographically.
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London
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