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The Effectiveness of a Nighttime Positioning Hand Splint in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502424
First Posted: July 17, 2007
Last Update Posted: July 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Study of the Effectiveness of a Positioning Hand Splint for Wrist, Fingers and Thumb in Patients With Arthritis Rheumatoid

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00502424     History of Changes
Other Study ID Numbers: 2304
First Submitted: July 16, 2007
First Posted: July 17, 2007
Last Update Posted: July 17, 2007
Last Verified: April 2007

Keywords provided by Federal University of São Paulo:
Rheumatoid Arthritis
Hand
Splint
Occupational Therapy

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases