Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Study of the Efficacy of Thumb Orthoses in the Base of the Thumb (BTOA)

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Thumb orthoses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Thumb orthoses|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at 1 month assessed on visual analog scale is the main outcome measure. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trapezotrapezoidial, scaphotrapezial, thumb, pain, orthoses, Osteoarthritis in the BTOA concerns the trapezometacarpal joint