Skip to main content
OpenTrials
Completed

NCT Number: NCT03017339

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio Grande do Norte

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Exercise

Other

Low level laser therapy

Radiation

Placebo Low Level Laser Therapy

Radiation

Low Level Laser Therapy with the device off

Primary outcomes

  1. Pain assessed by Visual Analogue Scale

    Time frame: Pain assessment two months after the intervention

    Assessed by Visual Analogue Scale

  2. Pain assessed by Widespread Pain Index

    Time frame: Pain assessment two months after the intervention

    Assessed by Widespread Pain Index

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2017
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.