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Completed

NCT Number: NCT00612248

Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

splint

Other

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

Primary outcomes

  1. Pain (VAS)

    Time frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)

Secondary outcomes

  1. Function (DASH)

    Time frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)

  2. Grip and pinch strength (dynamometer)

    Time frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)

  3. Dexterity (O'Connor test)

    Time frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand: A Randomized Controlled Study

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 11, 2008
Registry last updated
Feb 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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