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

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis	Other: Splint	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand: A Randomized Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

Pain (VAS) [ Time Frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	40
Study Start Date:	July 2005
Study Completion Date:	December 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SG Study group	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
No Intervention: CG Control group

Detailed Description:

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

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612248

Sponsors and Collaborators

Federal University of São Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

Study Chair:

Jamil Natour, MD

Federal University of São Paulo

More Information

No publications provided

Responsible Party:	Ana Claudia Gomes Carreira, UNIFESP - Universidade Federal de Sao Paulo
ClinicalTrials.gov Identifier:	NCT00612248 History of Changes
Other Study ID Numbers:	UNIFESP0108, CEP1090/03
Study First Received:	January 29, 2008
Last Updated:	January 29, 2008
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:

Osteoarthritis
Thumb
Splint

Pain
Function
Osteoarthritis of the trapeziometacarpal (TMC) joint

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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