Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA)
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Purpose
The prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted.
Interventions: Thumb orthoses to be worn at night and usual care vs usual care. Outcome measures: Pain at 1 month assessed on visual analog scale is the main outcome measure. Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures.
| Condition | Intervention |
|---|---|
|
Osteoarthritis |
Device: Thumb orthoses |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparative Study of the Efficacy of Thumb Orthoses in the Base of the Thumb (BTOA) |
- Pain at 1 month assessed on visual analog scale is the main outcome measure.
- Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures.
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | December 2005 |
The prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted. Radiologically defined osteoarthritis of the hand has been estimated to represent 38% of women and 24.5% of men over 66 years of age but higher prevalence of 60-70% has also been reported. Of patients with radiological signs, 20 to 40% become symptomatic. For patients over 55 years of age, the distal interphalangeal joints are the most prevalent site of osteoarthritis (20%) determined radiologically and clinically, followed by the base of the thumb (8%) and proximal interphalangeal joints (5%). This prevalence increases with age, and the incidence peaks in perimenopausal women. Osteoarthritis in the base of the thumb (BTOA) concerns the trapeziometacarpal joint, with a possible secondary location at the trapezotrapezoidial and scaphotrapezial joints. BTOA induces a closure of the first web, which in turn causes an alteration of the thumb-index pinch and therefore a limitation in hand function. Pain induced by the compression of the thumb column during pinching could also lead to functional disability. Effect of a simple intervention such as wearing rest thumb orthoses on pain and disability is unknown.
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pain at the base of the thumb 30 mm on VAS
- Patient aged 45 and < 75 years old
- At least 2 of the 5 items on the trapeziometacarpal joint radiograph osteophytes
- joint space narrowing
- subchondral bone sclerosis
- subchondral cysts
- At least 1 of the 2 clinical items trapeziometacarpal joint enlargement closure of the first web
Exclusion Criteria:
- Post traumatic osteoarthritis
- Cristal arthropathy
- Inflammatory arthritis
- Neurologic disorder involving upper limb
- Psychiatric disorder needing treatment adaptation in the last 3 months
- Hand or wrist trauma within the last 2 months
- Previous hand surgery
- Unable to speak or write French
- Pregnancy
- Collagen diseases (Dupuytren, Marfan, Ehlers Danlos syndromes)
- Hand or wrist infiltration within 2 months
- Skin disease interfering with the wearing of the orthoses
- Having already worn a BTOA orthoses
- Having bilateral BTOA without predominant symptomatic side
Contacts and Locations
More Information
No publications provided by Assistance Publique - Hôpitaux de Paris
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00350896 History of Changes |
| Other Study ID Numbers: | P020916 |
| Study First Received: | July 10, 2006 |
| Last Updated: | July 10, 2006 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
trapezotrapezoidial scaphotrapezial thumb |
pain orthoses Osteoarthritis in the BTOA concerns the trapezometacarpal joint |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013