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Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint

F

Federal University of São Paulo

Status and phase

Completed
Phase 2

Conditions

Osteoarthritis

Treatments

Other: Splint

Study type

Interventional

Funder types

Other

Identifiers

NCT00612248
CEP1090/03
UNIFESP0108

Details and patient eligibility

About

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.

Full description

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

Enrollment

40 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

SG
Experimental group
Description:
Study group
Treatment:
Other: Splint
CG
No Intervention group
Description:
Control group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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