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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Splint

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ana Carolina R Silva, student

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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UNIFESP - Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2304

Identifier Type: -

Identifier Source: org_study_id