Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00612248
First received: January 29, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted

January 29, 2008
January 29, 2008
July 2005
July 2007   (final data collection date for primary outcome measure)
Pain (VAS) [ Time Frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180) ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Function (DASH) [ Time Frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180) ] [ Designated as safety issue: Yes ]
  • Grip and pinch strength (dynamometer) [ Time Frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180) ] [ Designated as safety issue: Yes ]
  • Dexterity (O'Connor test) [ Time Frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint
Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand: A Randomized Controlled Study

Forty participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of a functional thumb splint for trapeziometacarpal OA in the dominant hand.

Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
Other: Splint
Patients in the study group received the splint on the day of the first evaluation and took it with them for use during activities of daily living and patients in the control group only used the splint during the evaluations
  • Experimental: SG
    Study group
    Intervention: Other: Splint
  • No Intervention: CG
    Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinical and radiological diagnosis of idiopathic Grade II and III OA of the TMC joint on the dominant hand;
  • either gender;
  • over 40 years of age;
  • pain in the base of the thumb of the dominant hand greater than three and less than or equal to seven on the 0 to 10-cm visual analogue scale (VAS) for pain.

Exclusion Criteria:

  • severe deformities of the dominant hand that did not allow gripping between the first, second and third fingers;
  • deformities of distal interphalangeal joint;
  • use of a splint on the thumb in the previous six months;
  • surgery on the hand under study in the previous six months or scheduled in the upcoming six months;
  • allergy to the splint material;
  • incapacity to respond to the questionnaire and perform the tests;
  • geographic inaccessibility;
  • injections in the hand under study in the previous six months;
  • other associated diseases such as carpal tunnel syndrome, fractures in the carpus, tendonitis, chronic inflammatory arthropathy;
  • alterations in the use of anti-inflammatory medication and analgesics in the previous three months.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00612248
UNIFESP0108, CEP1090/03
No
Ana Claudia Gomes Carreira, UNIFESP - Universidade Federal de Sao Paulo
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Chair: Jamil Natour, MD Federal University of São Paulo
Federal University of São Paulo
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP