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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00632710
First received: February 7, 2008
Last updated: March 4, 2008
Last verified: March 2008
History of Changes
  Purpose

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


Condition Intervention
Rheumatoid Arthritis
 Other: phototherapy
Other: phototherapy placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Effectiveness of Low-Level Laser Therapy on the Hands of Patients With Rheumatoid Arthritis: a Randomized Double-Blind Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • pain [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • function [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: July 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: b
laser
 Other: 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.
Other Name: soft laser therapy
Placebo Comparator: a
laser placebo
 Other: phototherapy placebo
disconnected laser (same device - experimental group)
Other Name: soft laser placebo therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632710

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04023-900
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Sandra M Meireles, Physiother. Federal University of São Paulo
  More Information

Additional Information:
Federal University of Sao Paulo  This link exits the ClinicalTrials.gov site
Brazilian Coordination of Upper Education Personal Improvement  This link exits the ClinicalTrials.gov site
Sao Paulo State Research Assistance Foundation  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Rheumatology Division, Federal University of Sao Paolo
ClinicalTrials.gov Identifier: NCT00632710     History of Changes
Other Study ID Numbers: 0829/04, FAPESP 2004/09374-1, CNPQ grant
Study First Received: February 7, 2008
Last Updated: March 4, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
rheumatoid arthritis
hands
randomized controlled
low level laser

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

ClinicalTrials.gov processed this record on May 23, 2013