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CompletedNCT03017339Updated Jan 11, 2017

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

An interventional study of Functional Exercise and Low Level Laser Therapy in Fibromyalgia, sponsored by Universidade Federal do Rio Grande do Norte. Completed at 1 site in Brazil. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-01-11.

Sponsored by Universidade Federal do Rio Grande do Norte · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Fibromyalgia

Keywords

  • Low Lever Laser Therapy
  • Exercise Therapy
  • Chronic Pain
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 22 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Universidade Federal do Rio Grande do Norte is the lead sponsor of 84 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (actual)

Study arms

  • 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

Interventions

  • OtherFunctional Exercise
  • RadiationLow Level Laser Therapy
  • RadiationPlacebo Low Level Laser Therapy

    Low Level Laser Therapy with the device off

06

What researchers measure

Primary outcomes

  1. Pain assessed by Visual Analogue Scale

    Assessed by Visual Analogue Scale

    Time frame: Pain assessment two months after the intervention

  2. Pain assessed by Widespread Pain Index

    Assessed by Widespread Pain Index

    Time frame: Pain assessment two months after the intervention

07

Study locations

1 site
  • Federal University of Rio Grande do Norte
    Natal, RN 59072-970, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03017339
Lead sponsor
Universidade Federal do Rio Grande do Norte
Responsible party
Wouber Hérickson de Brito Vieira (PhD, Universidade Federal do Rio Grande do Norte) — Principal investigator
First posted
Jan 11, 2017
Start date
Feb 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 11, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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