Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA)
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|ClinicalTrials.gov Identifier: NCT00350896|
Recruitment Status : Completed
First Posted : July 11, 2006
Last Update Posted : July 11, 2006
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 or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: Thumb orthoses||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Study of the Efficacy of Thumb Orthoses in the Base of the Thumb (BTOA)|
|Study Start Date :||December 2003|
|Study Completion Date :||December 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350896
|Principal Investigator:||Serge Poiraudeau, MD, Phd||Cochin Hospital AP-HP|