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

February 7, 2008
March 4, 2008
July 2004
December 2005   (final data collection date for primary outcome measure)
pain [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00632710 on ClinicalTrials.gov Archive Site
function [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Assessment of the Effectiveness of Low-Level Laser Therapy on the Hands of Patients With Rheumatoid Arthritis
Assessment of the Effectiveness of Low-Level Laser Therapy on the Hands of Patients With Rheumatoid Arthritis: a Randomized Double-Blind Controlled Trial

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • Other: phototherapy placebo
    disconnected laser (same device - experimental group)
    Other Name: soft laser placebo therapy
  • Experimental: b
    laser
    Intervention: Other: phototherapy
  • Placebo Comparator: a
    laser placebo
    Intervention: Other: phototherapy placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
December 2005
December 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00632710
0829/04, FAPESP 2004/09374-1, CNPQ grant
Yes
Rheumatology Division, Federal University of Sao Paolo
Federal University of São Paulo
Not Provided
Principal Investigator: Sandra M Meireles, Physiother. Federal University of São Paulo
Federal University of São Paulo
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP