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Clinical Trials/NCT03017339
NCT03017339
Completed
N/A

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

Universidade Federal do Rio Grande do Norte1 site in 1 country22 target enrollmentFebruary 2016
ConditionsFibromyalgia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Universidade Federal do Rio Grande do Norte
Enrollment
22
Locations
1
Primary Endpoint
Pain assessed by Visual Analogue Scale
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wouber Hérickson de Brito Vieira

PhD

Universidade Federal do Rio Grande do Norte

Eligibility Criteria

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;

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

Outcomes

Primary Outcomes

Pain assessed by Visual Analogue Scale

Time Frame: Pain assessment two months after the intervention

Assessed by Visual Analogue Scale

Pain assessed by Widespread Pain Index

Time Frame: Pain assessment two months after the intervention

Assessed by Widespread Pain Index

Study Sites (1)

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