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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis.

• Registration Number: NCT00502424
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-07
• Study Completion: 2006-07
• Status Verified: 2007-04
• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Last Update Submitted: 2007-07-16
• Study First Posted: 2007-07-17
• Last Update Posted: 2007-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UNIFESP - Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil