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

NCT ID: NCT00350896

Last Updated: 2006-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2005-12-31

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.

Conditions

Osteoarthritis

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Thumb orthoses

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Principal Investigators

Serge Poiraudeau, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Cochin Hospital AP-HP

References

Rannou F, Dimet J, Boutron I, Baron G, Fayad F, Mace Y, Beaudreuil J, Richette P, Ravaud P, Revel M, Poiraudeau S. Splint for base-of-thumb osteoarthritis: a randomized trial. Ann Intern Med. 2009 May 19;150(10):661-9. doi: 10.7326/0003-4819-150-10-200905190-00003.

Reference Type: DERIVED

PMID: 19451573 (View on PubMed)

Other Identifiers

P020916

Identifier Type: -

Identifier Source: org_study_id