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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00350896
Enrollment
120
Registered
2006-07-11
Start date
2003-12-31
Completion date
2005-12-31
Last updated
2006-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

trapezotrapezoidial, scaphotrapezial, thumb, pain, orthoses, Osteoarthritis in the BTOA concerns the trapezometacarpal joint

Brief 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.

Detailed description

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.

Interventions

DEVICEThumb orthoses

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026