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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Functional Exercise; Radiation: Low Level Laser Therapy; Radiation: Placebo Low Level Laser Therapy

• Registration Number: NCT03017339
• Lead Sponsor: Universidade Federal do Rio Grande do Norte

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-10
• Last Update Submitted: 2017-01-10
• Study First Posted: 2017-01-11
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Functional Exercise	The subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural
Laser Group	Low Level Laser Therapy	The subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural
Laser Group	Functional Exercise	The subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural
Placebo Group	Placebo Low Level Laser Therapy	The subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural

Primary Outcome Measures

Name	Time	Method
Pain assessed by Visual Analogue Scale	Pain assessment two months after the intervention	Assessed by Visual Analogue Scale
Pain assessed by Widespread Pain Index	Pain assessment two months after the intervention	Assessed by Widespread Pain Index

Trial Locations

Locations (1)

Federal University of Rio Grande do Norte; 🇧🇷 Natal, RN, Brazil