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

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. Identifier: NCT00502424
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : July 17, 2007
Information provided by:
Federal University of São Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis. Device: Splint Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Study Start Date : July 2004
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00502424

UNIFESP - Federal University of Sao Paulo
Sao Paulo, Brazil, 04023-900
Sponsors and Collaborators
Federal University of São Paulo
Principal Investigator: Ana Carolina R Silva, student Federal University of Sao Paulo Identifier: NCT00502424     History of Changes
Other Study ID Numbers: 2304
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: July 17, 2007
Last Verified: April 2007

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

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