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

NCT ID: NCT03017339

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laser Group

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

Group Type EXPERIMENTAL

Functional Exercise

Intervention Type OTHER

Low Level Laser Therapy

Intervention Type RADIATION

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

Group Type PLACEBO_COMPARATOR

Functional Exercise

Intervention Type OTHER

Placebo Low Level Laser Therapy

Intervention Type RADIATION

Low Level Laser Therapy with the device off

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Functional Exercise

Intervention Type OTHER

Low Level Laser Therapy

Intervention Type RADIATION

Placebo Low Level Laser Therapy

Low Level Laser Therapy with the device off

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wouber Hérickson de Brito Vieira

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1.442.759

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.