FibromyalgiaNCT03017339
Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Fibromyalgia
A study testing Functional Exercise and Low Level Laser Therapy in people with Fibromyalgia, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Functional Exercise and Low Level Laser Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59072-970
About this study
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
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.
- Conditions
- Fibromyalgia
- Being tested
- Functional Exercise, Low Level Laser Therapy, Placebo Low Level Laser Therapy
- Keywords
- Low Lever Laser Therapy, Exercise Therapy, Chronic Pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional ExerciseOther
Low Level Laser TherapyRadiation
Placebo Low Level Laser TherapyRadiation
Low Level Laser Therapy with the device off
| Study group | Role | What they receive |
|---|---|---|
| Laser Group | Experimental | The subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural Receives: Other: Functional Exercise; Radiation: Low Level Laser Therapy |
| Placebo Group | Placebo comparator | The subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural Receives: Other: Functional Exercise; Radiation: Placebo Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by Visual Analogue Scale
Assessed by Visual Analogue Scale
Measured: Pain assessment two months after the intervention
Pain assessed by Widespread Pain Index
Assessed by Widespread Pain Index
Measured: Pain assessment two months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wouber Hérickson de Brito Vieira, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017339
- Sponsor's protocol ID
- 1.442.759
- Status last verified
- Jan 2017
- First submitted
- 4 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03017339
- Acronym / sponsor ID
- 1.442.759
- Conditions
- Fibromyalgia
- Keywords
- Low Lever Laser Therapy, Exercise Therapy, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Group | Experimental | Other: Functional Exercise, Radiation: Low Level Laser TherapyThe subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural |
| Placebo Group | Placebo comparator | Other: Functional Exercise, Radiation: Placebo Low Level Laser TherapyThe subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Exercise | Other | Laser Group, Placebo Group |
| Low Level Laser Therapy | Radiation | Laser Group |
| Placebo Low Level Laser TherapyLow Level Laser Therapy with the device off | Radiation | Placebo Group |
Primary outcome
Pain assessed by Visual Analogue Scale
Time frame: Pain assessment two months after the intervention
Assessed by Visual Analogue Scale
Pain assessed by Widespread Pain Index
Time frame: Pain assessment two months after the intervention
Assessed by Widespread Pain Index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Exercise and Low Level Laser Therapy in people with Fibromyalgia, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by Visual Analogue Scale (time frame: Pain assessment two months after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.