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

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Functional Exercise; Radiation: Low Level Laser Therapy; Radiation: Placebo Low Level Laser Therapy

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RN
    • Natal, RN, Brazil, 59072-970
      • Federal University of Rio Grande do Norte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Group; 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; Radiation: Low Level Laser Therapy
Placebo Comparator: Placebo Group; 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; Radiation: Placebo Low Level Laser Therapy; Low Level Laser Therapy with the device off

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Pain; Low Lever Laser Therapy; Exercise Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 1.442.759

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No