CompletedNot Applicable

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

120 participantsStarted 2003-12

Plain-language summary

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.

Who can participate

Age range45 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pain at 1 month assessed on visual analog scale is the main outcome measure.

Trial details

NCT IDNCT00350896

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL