Assessment of the Effectiveness of Low-Level Laser Therapy on the Hands of Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
phototherapy
phototherapy placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, hands, randomized controlled, low level laser
Eligibility 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.
Sites / Locations
- Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
b
a
Arm Description
laser
laser placebo
Outcomes
Primary Outcome Measures
pain
Secondary Outcome Measures
function
Full Information
NCT ID
NCT00632710
First Posted
February 7, 2008
Last Updated
March 4, 2008
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00632710
Brief Title
Assessment of the Effectiveness of Low-Level Laser Therapy on the Hands of Patients With Rheumatoid Arthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, hands, randomized controlled, low level laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
b
Arm Type
Experimental
Arm Description
laser
Arm Title
a
Arm Type
Placebo Comparator
Arm Description
laser placebo
Intervention Type
Other
Intervention Name(s)
phototherapy
Other Intervention Name(s)
soft laser therapy
Intervention Description
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
Intervention Name(s)
phototherapy placebo
Other Intervention Name(s)
soft laser placebo therapy
Intervention Description
disconnected laser (same device - experimental group)
Primary Outcome Measure Information:
Title
pain
Time Frame
2 months
Secondary Outcome Measure Information:
Title
function
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra M Meireles, Physiother.
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil
12. IPD Sharing Statement
Links:
URL
http://www.unifesp.br
Description
Federal University of Sao Paulo
URL
http://www.capes.gov.br
Description
Brazilian Coordination of Upper Education Personal Improvement
URL
http://www.fapesp.br
Description
Sao Paulo State Research Assistance Foundation
Learn more about this trial
Assessment of the Effectiveness of Low-Level Laser Therapy on the Hands of Patients With Rheumatoid Arthritis
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