The Effectiveness of a Nighttime Positioning Hand Splint in Patients With Rheumatoid Arthritis - Full Text View

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00502424

Purpose

The purpose of the present study was to evaluate the effectiveness of a nighttime positioning hand splint in patients with RA in terms of pain, grip and pinch strength, upper limb function, quality of life, and patient satisfaction. The hypothesis is that the stabilization of hand during nighttime could decrease pain and consequently improve quality of life.

Condition	Intervention	Phase
Rheumatoid Arthritis.	Device: Splint	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Study of the Effectiveness of a Positioning Hand Splint for Wrist, Fingers and Thumb in Patients With Arthritis Rheumatoid

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

Primary Outcome Measures:

Pain using VAS at rest in cm, strength (grip and pinch), activities of daily living using HAQ questionnaire, hand function using DASH questionnaire and satisfaction with use by a likert scale of five points (much worst to much better). [ Time Frame: Three months ]

Enrollment:	50
Study Start Date:	July 2004
Study Completion Date:	July 2006

Detailed Description:

The involvment of wrist and fingers is very common in RA and it could affect hand function and, consequently, affect activities of daily living (ADL). Some authors suggest that the rest of hand could decrease pain and inflammation. Splints are external appliances that used in a specific body part provides the best alignment and rest in correct functional position. The goal of a hand, fingers and thumb in RA is stabilize the hand while the patients are not making theirs ADL and try to decrease the pain.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Rheumatoid arthritis classified according to the ACR criteria.
Use of the same remissive drugs for at least 6 months before the intervention and the same doses of the same corticosteroids and nonsteroidal anti-inflammatory drugs for at least one month before the study.
A score ≥ 3 and ≤ 7 on a visual analog scale (VAS) for pain in the more aching hand.
Agreement to participate in the study, and signing of a free informed consent form.

Exclusion Criteria:

Presented deformities in the more aching hand that did not permit fabrication of the splint.
Patients using any other type of upper limb splint.
Patients with a surgery scheduled within 6 months after the study.
Patients allergic to the splint material.
Patients with mental deficiency.
Patients who lived in inaccessible areas.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502424

Locations

Brazil
UNIFESP - Federal University of Sao Paulo
Sao Paulo, Brazil, 04023-900

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:

Ana Carolina R Silva, student

Federal University of Sao Paulo

More Information

Study ID Numbers:	2304
Study First Received:	July 16, 2007
Last Updated:	July 16, 2007
ClinicalTrials.gov Identifier:	NCT00502424
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:

Rheumatoid Arthritis
Hand
Splint
Occupational Therapy

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009