Assessment of the Effectiveness of Low-Level Laser Therapy on the Hands of Patients With Rheumatoid Arthritis
|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|
- pain [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- function [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2004|
|Study Completion Date:||December 2005|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
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
Other: phototherapy placebo
disconnected laser (same device - experimental group)
Other Name: soft laser placebo therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632710
|Federal University of Sao Paulo|
|Sao Paulo, SP, Brazil, 04023-900|
|Principal Investigator:||Sandra M Meireles, Physiother.||Federal University of São Paulo|