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

Rheumatoid Arthritis. Clinical Trial

Official title:

Study of the Effectiveness of a Positioning Hand Splint for Wrist, Fingers and Thumb in Patients With Arthritis Rheumatoid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502424
• Other study ID #: 2304
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2007
• Last updated: July 16, 2007
• Start date: July 2004
• Est. completion date: July 2006

Study information

• Verified date: April 2007
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis.

Intervention

Device:
• Splint

Locations

Country	Name	City	State
Brazil	UNIFESP - Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Three months