Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Fibromyalgia

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of a functional exercise program associated with Low Level Laser Therapy (LLLT) on pain, functional capacity and quality of life of individuals with fibromyalgia. Half of participants will receive functional exercise and LLLT, while the other half will receive functional exercise and placebo LLLT.

Official Title
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Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Pain, Functional Capacity and Quality of Life in Individuals With Fibromyalgia: A Double-blind Randomized Clinical Trial

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Functional Exercise
* Radiation: Low Level Laser Therapy
* Radiation: Placebo Low Level Laser Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being female; age between 30 and 50 years; have an ovulatory cycle; height between 1.50m and 1.80m, body mass between 50 and 80 kg and BMI in the range of 18.5 to 29.9 kg / m2; present a clinical diagnosis of fibromyalgia, signed by a rheumatologist according to the current criteria of the American College of Rheumatology; is at least 6 months without any physical exercise; do not present musculoskeletal conditions that prevent them from performing the evaluation and proposed physical activity, except FM; not having diabetes mellitus and uncontrolled blood pressure; they do not present an inflammatory rheumatic condition or serious cardiovascular and / or pulmonary disease that prevents them from performing the evaluation and the proposed physical activity; Not having psychiatric illness or having malignant tumors; is not pregnant did not present dengue, zika or chikungunya in the last year; and finally not to be hypersensitive to light. Exclusion Criteria: not attend for more than two consecutive exercise sessions at any time and for any reason expressing an intention to leave the study present a health problem that prevents them from continuing to carry out the proposed exercises

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Group<br>The subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural | Other: Functional Exercise<br> <br> Radiation: Low Level Laser Therapy<br> <br> |
| Placebo Comparator: Placebo Group<br>The subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural | Other: Functional Exercise<br> <br> Radiation: Placebo Low Level Laser Therapy<br>* Low Level Laser Therapy with the device off<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed by Visual Analogue Scale | Assessed by Visual Analogue Scale | Pain assessment two months after the intervention | 
| Pain assessed by Widespread Pain Index | Assessed by Widespread Pain Index | Pain assessment two months after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Lever Laser Therapy, Exercise Therapy, Chronic Pain