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 range

45 Years – 75 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Osteoarthritis trials