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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Functional Exercise
Low Level Laser Therapy
Placebo Low Level Laser Therapy
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Low Lever Laser Therapy, Exercise Therapy, Chronic Pain

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Rio Grande do Norte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Laser Group

Placebo Group

Arm Description

The subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural

The subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural

Outcomes

Primary Outcome Measures

Pain assessed by Visual Analogue Scale
Assessed by Visual Analogue Scale
Pain assessed by Widespread Pain Index
Assessed by Widespread Pain Index

Secondary Outcome Measures

Full Information

First Posted
January 4, 2017
Last Updated
January 10, 2017
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03017339
Brief Title
Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Fibromyalgia
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Low Lever Laser Therapy, Exercise Therapy, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Group
Arm Type
Experimental
Arm Description
The subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
The subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural
Intervention Type
Other
Intervention Name(s)
Functional Exercise
Intervention Type
Radiation
Intervention Name(s)
Low Level Laser Therapy
Intervention Type
Radiation
Intervention Name(s)
Placebo Low Level Laser Therapy
Intervention Description
Low Level Laser Therapy with the device off
Primary Outcome Measure Information:
Title
Pain assessed by Visual Analogue Scale
Description
Assessed by Visual Analogue Scale
Time Frame
Pain assessment two months after the intervention
Title
Pain assessed by Widespread Pain Index
Description
Assessed by Widespread Pain Index
Time Frame
Pain assessment two months after the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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; 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
Facility Information:
Facility Name
Federal University of Rio Grande do Norte
City
Natal
State/Province
RN
ZIP/Postal Code
59072-970
Country
Brazil

12. IPD Sharing Statement

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

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