|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00350896 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Comparative Study of the Efficacy of Thumb Orthoses in the Base of the Thumb (BTOA) |
| 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:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | P020916 |
| Study First Received: | July 10, 2006 |
| Last Updated: | July 10, 2006 |
| ClinicalTrials.gov Identifier: | NCT00350896 History of Changes |
| Health Authority: | France: Ministry of Health |
|
trapezotrapezoidial scaphotrapezial thumb |
pain orthoses Osteoarthritis in the BTOA concerns the trapezometacarpal joint |
|
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |