Action of low power laser on pain and quality of life and sleep in patients with fibromyalgia

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-42gkzt
• Date of registration: 14/02/2012
• Primary sponsor: Universidade Nove de Julho - São Paulo, SP, Brazil
• Public title: Action of low power laser on pain and quality of life and sleep in patients with fibromyalgia
• Scientific title: Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia
• Date of first enrolment: 01/03/2011
• Target sample size: 36
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-42gkzt/
• Study design: Therapeutic, parallel, two arms, double-blind, randomized clinical trial

Countries of recruitment

Brazil

Contacts

• Name: Paulo de Tarso de Carvalho
• Affiliation: Universidade Nove de Julho

• Name: Paulo de Tarso de Carvalho
• Affiliation: Universidade Nove de Julho

Key inclusion & exclusion criteria

Inclusion criteria: A clinical diagnosis of fibromyalgia based on American College of Rheumatology criteria;
Cognitive level sufficient for understanding the procedures and following the instructions;
Agreement to participate in the study and the signing of a statement of informed consent after receiving clarifications regarding the objectives of the study.

Exclusion criteria: Psychiatric disorders, history of drug abuse or other behaviors that require intervention psychiatric medication;
Development of uncontrolled clinical situations that prevent participation in aerobic activities, for efforts or group activities;
History of epilepsy, seizures, heart disease and arrhythmias;
A pacemaker;
Presence of undiagnosed pain;
Pregnant women;
Patients with malignant tumors.

Age minimum: 0
Age maximum: 0Y
Gender: F

Health Condition(s) or Problem(s) studied

Fibromyalgia, Sleep Disorders, Pain, Quality of Life
C05.651.324
C10.886
I01.800
C10.597.617

Intervention(s)

In the 36 study participants, will be applied to laser therapy low power (TLBP) on an automated laser (Twin Laser - MM Optics, São Paulo) who possessed two identical points of application provided by the manufacturer, with an active tip (TLBP group) and the other placebo, which does not emit energy (control group), but both possess the buzzer and the light guide. The two groups with 18 patients in each will receive four times applications per week for a period of three weeks a total of twelve sections. Applications shall be made in a timely and direct contact between the tip and the patient's skin. However, only the group patients will receive an effective radiation energy density of 6 Jcm ². Both groups held after the applications an exercise program lasting 50 minutes, which will include a 10 minute warm up and stretching, 30 minutes of aerobic exercise on treadmill and 10 minutes of relaxation exercises and stretching three times a week, during the four weeks of the study. "

Primary Outcome(s)

Improvement in pain, assessed using the following instruments: visual analogue pain scale, McGill Pain Questionnaire and pressure algometry. It is expected that the group treated with low power laser presents significant reduction of pain intensity scale analogic visual and increased pain threshold force to the pressure in algometry and the lower frequency in the selection of pain descriptors in categories affective and sensory and psycho-emotional component in the responses obtained in the McGill Pain questionnaire

Secondary Outcome(s)

Improving quality of life and sleep, as assessed through the following instruments: test generic Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the specific Fibromyalgia Impact Questionnaire (FIQ), polysomnography, and questionnaire Berlin Epworth sleepiness scale.It is expected that the group treated with low-power laser shows improvement in overall quality of life as assessed by testing generic Medical Outcomes Study 36-Item and Short-Form Health Survey (SF-36) mainly in the items, which include scales related to functional capacity, physical, bodily pain, general health and vitality. In the questionnaire Fibromyalgia Impact Questionnaire (FIQ), is expected to improve the quality of life issues related to the functional capacity, employment status, psychological distress and physical symptoms. In the items related to sleep quality as polysomnography, the Berlin questionnaire and Epworth sleepiness scale is expected to improve the quality of sleep.

Secondary ID(s)

0421.0.241.000-11

474921

Source(s) of Monetary Support

CNPQ - Brazil

Secondary Sponsor(s)

Universidade Nove de Julho - São Paulo, SP, Brazil