Assessment of the Effectiveness of Low-Level Laser Therapy on the Hands of Patients With Rheumatoid Arthritis

NCT ID: NCT00632710

Last Updated: 2008-03-11

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

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-12-31

Brief Summary

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The purpose of the present study was to assess the effectiveness of low-level laser therapy on the reduction in pain and improvement in function in the hands of patients with rheumatoid arthritis

Detailed Description

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Rheumatoid arthritis (RA) is a chronic inflammatory disease of unknown etiology that basically compromises the joints in a generalized, symmetrical, additive and usually progressive manner. This clinical condition includes pain and altered functionality. Low-level laser therapy (LLLT) has been studied since the 1970s with regard to its therapeutic effects. The literature suggests that it offers analgesic as well as anti-inflammatory benefits.

A number of studies carried out in the laboratory and on animals have shown that LLLT contributes toward the treatment of inflammatory joint disease. However, studies on humans with RA have yielded controversial results. A large part of the authors researched state that further randomized double-blind controlled studies should be carried out to prove the effectiveness of LLLT on RA. Thus, the aim of the present study was to assess the effectiveness of LLLT on the reduction in pain and improvement in function in the hands of patients with RA.

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

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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b

laser

Group Type EXPERIMENTAL

phototherapy

Intervention Type OTHER

The laser used was low-level Aluminum Gallium Arsenide (AlGaAs)diodo laser, at a wavelength of 785 nm (infrared), dose of 3 J/cm2, mean power of 70 mW, 3 sec. per point, laser beam of 0,06cm2, BIOSET brand - Indústria de Tecnologia Eletrônica Ltda -Rio Claro, Brazil.

a

laser placebo

Group Type PLACEBO_COMPARATOR

phototherapy placebo

Intervention Type OTHER

disconnected laser (same device - experimental group)

Interventions

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phototherapy

The laser used was low-level Aluminum Gallium Arsenide (AlGaAs)diodo laser, at a wavelength of 785 nm (infrared), dose of 3 J/cm2, mean power of 70 mW, 3 sec. per point, laser beam of 0,06cm2, BIOSET brand - Indústria de Tecnologia Eletrônica Ltda -Rio Claro, Brazil.

Intervention Type OTHER

phototherapy placebo

disconnected laser (same device - experimental group)

Intervention Type OTHER

Other Intervention Names

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soft laser therapy soft laser placebo therapy

Eligibility Criteria

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Inclusion Criteria

* patients with RA
* inflammatory condition of at least two hand joints among the wrists, proximal interphalangeal (PIP) joint and metacarpophalangeal (MCP) joint
* visual analogue scale (VAS) for pain between 3 and 8 cm during activities of daily living
* and being of either gender

Exclusion Criteria

* skin lesions at the application site
* other illnesses affecting the hands; physiotherapy for the hands in the previous three months
* joint injections in the previous three months
* change in disease-modifying anti-rheumatic drugs in the previous three months
* and change in corticosteroids in the previous month.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Sao Paolo

Principal Investigators

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Sandra M Meireles, Physiother.

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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http://www.unifesp.br

Federal University of Sao Paulo

http://www.capes.gov.br

Brazilian Coordination of Upper Education Personal Improvement

http://www.fapesp.br

Sao Paulo State Research Assistance Foundation

Other Identifiers

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FAPESP 2004/09374-1

Identifier Type: -

Identifier Source: secondary_id

CNPQ grant

Identifier Type: -

Identifier Source: secondary_id

0829/04

Identifier Type: -

Identifier Source: org_study_id

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