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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00350896
First received: July 10, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Osteoarthritis
Device: Thumb orthoses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of the Efficacy of Thumb Orthoses in the Base of the Thumb (BTOA)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Pain at 1 month assessed on visual analog scale is the main outcome measure.

Secondary Outcome Measures:
  • Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures.

Estimated Enrollment: 120
Study Start Date: December 2003
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350896

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Serge Poiraudeau, MD, Phd Cochin Hospital AP-HP
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00350896     History of Changes
Other Study ID Numbers: P020916
Study First Received: July 10, 2006
Last Updated: July 10, 2006
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
trapezotrapezoidial
scaphotrapezial
thumb
pain
orthoses
Osteoarthritis in the BTOA concerns the trapezometacarpal joint

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014