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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017339
• Other study ID #: 1.442.759
• Status: Completed
• Phase: N/A
• First received: January 4, 2017
• Last updated: January 10, 2017
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Functional Exercise

Radiation:
• Low Level Laser Therapy

• Placebo Low Level Laser Therapy
Low Level Laser Therapy with the device off

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Norte	Natal	RN

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessed by Visual Analogue Scale	Assessed by Visual Analogue Scale	Pain assessment two months after the intervention	No
Primary	Pain assessed by Widespread Pain Index	Assessed by Widespread Pain Index	Pain assessment two months after the intervention	No