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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014