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Trial record 24 of 277 for:    quality | "Fibromyalgia"

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

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ClinicalTrials.gov Identifier: NCT03017339
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Wouber Hérickson de Brito Vieira, Universidade Federal do Rio Grande do Norte

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Functional Exercise Radiation: Low Level Laser Therapy Radiation: Placebo Low Level Laser Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017339


Locations
Brazil
Federal University of Rio Grande do Norte
Natal, RN, Brazil, 59072-970
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte

Responsible Party: Wouber Hérickson de Brito Vieira, PhD, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT03017339     History of Changes
Other Study ID Numbers: 1.442.759
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Keywords provided by Wouber Hérickson de Brito Vieira, Universidade Federal do Rio Grande do Norte:
Low Lever Laser Therapy
Exercise Therapy
Chronic Pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases