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

NCT03017339 | Completed DMC

• 1 other identifier: 1.442.759
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Low Lever Laser Therapy; Exercise Therapy; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Laser Group

EXPERIMENTAL

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 Group

PLACEBO COMPARATOR

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

Interventions

Functional Exercise OTHER

Laser Group; Placebo Group

Low Level Laser Therapy RADIATION

Laser Group

Placebo Low Level Laser Therapy RADIATION

Low Level Laser Therapy with the device off

Placebo Group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59072-970, Brazil

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 11, 2017
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

BR (1)