Analysis of low level laser therapy in the treatment of patients with fibromyalgia

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-63xvgf
• Date of registration: 10/05/2012
• Primary sponsor: Universidade Estadual do Oeste do Paraná - UNIOESTE - Cascavel, PR, Brazil
• Public title: Analysis of low level laser therapy in the treatment of patients with fibromyalgia
• Scientific title: Analysis of low level laser therapy in the treatment of patients with fibromyalgia
• Date of first enrolment: 10/01/2011
• Target sample size: 20
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-63xvgf/
• Study design: Therapeutic, parallel, 2-arms, single-blinded, randomized clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: João Ruaro
• Affiliation: Universidade Federal do Rio Grande do Norte

• Name: João Ruaro
• Affiliation: Universidade Federal do Rio Grande do Norte

Key inclusion & exclusion criteria

Inclusion criteria: Clinical diagnosis of fibromyalgia;
Age between 20 and 80 years;
Signing the consent form;
Exclusion criteria: Don´t have

Age minimum: 20Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

Fibromyalgia and Quality of life
C05.651.324
I01.800
C10.597.617

Intervention(s)

Twenty patients divided into treatment group (TG, n=10) and placebo group (PG, n=10). The TG was submitted to low level laser GaAlAs (Gallium Arsenide and Aluminum) 670 nm, 4 J/cm2 in the 18 predetermined anatomical sites, called tender points, 3 times a week for 4 weeks. The evaluation was made by specific form, Fibromyalgia Impact Questionnaire (FIQ), Medical Outcome Survey Short-Form 36 (SF-36), McGill Pain Questionnaire and Visual Analogue Scale (VAS) of pain.

Primary Outcome(s)

Possible improvement in the symptom of pain in patients with fibromyalgia, as measured by the McGill Pain Questionnaire and the visual analog scale. The McGill Pain Questionnaire consists of 78 words used to describe pain, qualitatively similar, grouped into four categories: sensory-discrimativo, sensory, affective, cognitive and miscellaneous. It is expected to reduce the contents of this questionnaire. The visual analog scale of pain consists of a line of 10 cm, where 0 represents no pain and 10 representing the worst pain imaginable, and is recommended for adults. It is expected that the reduction in the scale. Moreover, it is expected to reduce the number of tender points, measured between the initial and final assessment.

Secondary Outcome(s)

Increase the quality of life as measured by the SF-36 and FIQ. The SF-36 includes eight scales: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Shows a final score of 0-100, where "0" is the worst overall health status and "100" the best general health. It is expected an increase in the score of the questionnaire. The FIQ evaluates 10 domains: physical functioning, wellness, work absenteeism, difficulties at work, pain, fatigue, stiffness, sleep disturbances, anxiety and depression. There are 11 items ranked by the Likert scale, which involves values from 0 (always) to 3 (never). It is expected to decrease the score of the questionnaire.

Secondary ID(s)

Protocolo 015915/2005

Source(s) of Monetary Support

Universidade Estadual do Oeste do Paraná - UNIOESTE - Cascavel, PR, Brazil

Secondary Sponsor(s)

Universidade do Vale do Paraíba - UNIVAP - São José dos Campos, SP, Brazil