FibromyalgiaNCT04322812
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Fibromyalgia
A study testing Active PBMT in people with Fibromyalgia, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Fibromyalgia (FM) syndrome is defined by the American College of Rheumatology (ACR), as a chronic widespread pain and tenderness in at least eleven of eighteen specific tender points. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Active PBMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Mar 2020to 30 Oct 2020
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- being female;
- age between 30 and 55 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 > or = to 18.5 kg/ m2;
- present a diagnosis of fibromyalgia and meet the current criteria of the American College of Rheumatology;
- had symptoms of fibromyalgia greater than 3 months;
Show all 14Show fewer
- Widespread Pain Index (WPI) score > or = to 9, Visual Analogue Scale score > or = to 50 Fibromyalgia Impact Questionnaire score > or = to 50
- is not pregnant;
- not having diabetes mellitus and uncontrolled blood pressure;
- not having psychiatric illness or having malignant tumors;
- did not present dengue, Zika or Chikungunya in the last year;
- not to be hypersensitive to light;
- cognitive level enough to understand the procedures and follow the guidelines;
- consent to participate in the study and sign the consent form.
Who cannot join
- arthritis, chronic fatigue syndrome, lupus, auto-immune diseases;
- cognitive changes;
- people who perform some exercise;
- having a pacemaker;
- people under the age of 30 and more than 55 years;
- injuries in the last 6 months;
- not attend for more than two consecutive sessions;
- at any time and for any reason expressing an intention to leave the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, 01504-001
About this study
Official title: Evaluation of the Effects of Photobiomodulation Therapy (PBMT) Combined With Static Magnetic Field (sMF) on Temporary Pain Relief in Fibromyalgia Patients: a Randomized Placebo-controlled Trial
Fibromyalgia (FM) syndrome is defined by the American College of Rheumatology (ACR), as a chronic widespread pain and tenderness in at least eleven of eighteen specific tender points. Despite the increased understanding about FM, there is currently no cure for this syndrome and the treatment aims to provide symptomatic relief and improvement of physical capacities to perform daily tasks and quality of life. Evidence has suggest that photobiomodulation therapy (PBMT) can be used as monotherapy or as a supplementary treatment to other therapeutic procedures in patients with FM. However, the lack of consensus regarding therapeutic protocols hinders multicenter comparisons of the many clinical trials published. Further studies are needed to establish ideal parameters of PBMT to be used as a therapeutic tool in the management of fibromyalgia. Therefore, the aim of this project is to investigate the effectiveness of PBMT combined with static magnetic fields (sMF) in pain relief in patients with fibromyalgia.
Read the detailed description
To achieve the proposed objectives it will be performed a randomized, triple-blind, placebo-controlled trial, with voluntary patients with fibromyalgia. Ninety patients will be randomly allocated to two treatment groups: 1. Active PBMT (MR5™ ACTIV PRO LaserShower) or Placebo PBMT (MR5™ ACTIV PRO LaserShower). The patients will be treated by a blinded therapist.
The patients randomly allocated to the different groups will be subjected to treatment 3 times a week, total of 9 sessions (with approximately 48 hours between each session), a total of 3 weeks of treatment.
The clinical outcomes will be obtained at the stabilization phase, baseline, end of treatment and 30 days after the conclusion of treatment.
The data will be collected by a blinded assessor.
Statistical analyzis:
- The primary statistical method to analyze the primary endpoint will be Fisher's Exact Test to compare the proportion of success between the test (Active PBMT) and the control procedure (Placebo PBMT) groups, considering that randomization has been diligently conducted and important covariates between the two groups are well balanced. Statistical significance is set at p < 0.05.
- Unpaired T test will be applied to analyze pain intensity through EVA. Mean and individual subject changes in VAS ratings across and between all study evaluation time-points, within and between procedure groups considering that randomization has been diligently conducted and important covariates between the two groups are well balanced. Statistical significance is set at p<0.05.
- For patient satisfaction, measured through a Likert Scale, the data will be reduced to the nominal level by combining all agree and disagree responses into two categories of "accept" and "reject". Differences in satisfaction with Study Outcome Ratings between procedure groups at both evaluated time-points, and any change between. The chi-square, will be used after this transformation. Statistical significance is set at p<0.05.
The investigators will analyze: degree of pain rating (tender point count), pain intensity, patient satisfaction and adverse events
- Conditions
- Fibromyalgia
- Being tested
- Active PBMT, Placebo PBMT
- Keywords
- Photobiomodulation Therapy, Low-level Laser Therapy, Fibromyalgia, Pain intensity
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PBMTDevice
The Active PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA) will be used. The ACTIV PRO emits 30mW of 905nm, 300mW of 850nm, 200mW of 660nm and 0mW of 455nm light via an electric diode energy source. PBMT will be applied using the direct contact method with light pressure on the skin. The PBMT application time will be 120 seconds per region and the total time will vary according to the number of regions to be treated. Only the painful regions on that day will be treated (according widespread pain index [WPI] ), which can comprise a minimum of 3 and a maximum of 18 regions in total. The dose used for applications during the treatment will be 60 Joules (J) per region. The total dose might vary between patients and each session.
Placebo PBMTDevice
The placebo PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA). The ACTIV PRO emits 905nm, and 850nm via an electric diode energy source with outputs to 0%. The 660nm light via an electric diode energy source with outputs to >1% to appear like the active comparator. PBMT will be applied using the direct contact method with light pressure on the skin. The placebo PBMT application time will be 115 seconds per region and the total time will vary according to the number of regions to be treated. Only the painful regions on that day will be treated (according WPI), which can comprise a minimum of 3 and a maximum of 18 regions in total. The dose used for applications during the treatment will be 0 Joules (J) per region. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).
| Study group | Role | What they receive |
|---|---|---|
| Active PBMT | Active comparator | Active PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions. Receives: Device: Active PBMT |
| Placebo PBMT | Placebo comparator | Placebo PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions. Receives: Device: Placebo PBMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain rating - change of TCP (tender point count)
Reduction of the tender point count (TCP) where they have experienced pain as reported on Fibromyalgia Impact Questionnaire (FIQ).
Measured: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Secondary outcomes (3)
Pain intensity - VAS
Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).
Measured: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Patient satisfaction - Likert Scale
Patient satisfaction will be measured by 1-item Likert Scale. The scale uses the following responses: very satisfied = 4; somewhat satisfied = 3; not very satisfied = 2; not at all satisfied =1. Highest scores indicates better satisfaction.
Measured: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Adverse events
Adverse events will be measured by report.
Measured: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start31 Mar 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Multi Radiance Medical
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
- Investigators
- Ernesto Cesar Pinto Leal Junior, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322812
- Sponsor's protocol ID
- 2.732.062
- Status last verified
- Jun 2021
- First submitted
- 24 Mar 2020
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Photobiomodulation Therapy (PBMT) Combined With Static Magnetic Field (sMF) on Temporary Pain Relief in Fibromyalgia Patients: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04322812
- Acronym / sponsor ID
- 2.732.062
- Conditions
- Fibromyalgia
- Keywords
- Photobiomodulation Therapy, Low-level Laser Therapy, Fibromyalgia, Pain intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Multi Radiance Medical
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 26 Mar 2020 (actual)
- 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.
Fibromyalgia (FM) syndrome is defined by the American College of Rheumatology (ACR), as a chronic widespread pain and tenderness in at least eleven of eighteen specific tender points. Despite the increased understanding about FM, there is currently no cure for this syndrome and the treatment aims to provide symptomatic relief and improvement of physical capacities to perform daily tasks and quality of life. Evidence has suggest that photobiomodulation therapy (PBMT) can be used as monotherapy or as a supplementary treatment to other therapeutic procedures in patients with FM. However, the lack of consensus regarding therapeutic protocols hinders multicenter comparisons of the many clinical trials published. Further studies are needed to establish ideal parameters of PBMT to be used as a therapeutic tool in the management of fibromyalgia. Therefore, the aim of this project is to investigate the effectiveness of PBMT combined with static magnetic fields (sMF) in pain relief in patients with fibromyalgia.
Detailed description
To achieve the proposed objectives it will be performed a randomized, triple-blind, placebo-controlled trial, with voluntary patients with fibromyalgia. Ninety patients will be randomly allocated to two treatment groups: 1. Active PBMT (MR5™ ACTIV PRO LaserShower) or Placebo PBMT (MR5™ ACTIV PRO LaserShower). The patients will be treated by a blinded therapist.
The patients randomly allocated to the different groups will be subjected to treatment 3 times a week, total of 9 sessions (with approximately 48 hours between each session), a total of 3 weeks of treatment.
The clinical outcomes will be obtained at the stabilization phase, baseline, end of treatment and 30 days after the conclusion of treatment.
The data will be collected by a blinded assessor.
Statistical analyzis:
- The primary statistical method to analyze the primary endpoint will be Fisher's Exact Test to compare the proportion of success between the test (Active PBMT) and the control procedure (Placebo PBMT) groups, considering that randomization has been diligently conducted and important covariates between the two groups are well balanced. Statistical significance is set at p < 0.05.
- Unpaired T test will be applied to analyze pain intensity through EVA. Mean and individual subject changes in VAS ratings across and between all study evaluation time-points, within and between procedure groups considering that randomization has been diligently conducted and important covariates between the two groups are well balanced. Statistical significance is set at p<0.05.
- For patient satisfaction, measured through a Likert Scale, the data will be reduced to the nominal level by combining all agree and disagree responses into two categories of "accept" and "reject". Differences in satisfaction with Study Outcome Ratings between procedure groups at both evaluated time-points, and any change between. The chi-square, will be used after this transformation. Statistical significance is set at p<0.05.
The investigators will analyze: degree of pain rating (tender point count), pain intensity, patient satisfaction and adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PBMT | Active comparator | Device: Active PBMTActive PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions. |
| Placebo PBMT | Placebo comparator | Device: Placebo PBMTPlacebo PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- being female;
- age between 30 and 55 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 > or = to 18.5 kg/ m2;
- present a diagnosis of fibromyalgia and meet the current criteria of the American College of Rheumatology;
Key exclusion criteria (8 listed)
- arthritis, chronic fatigue syndrome, lupus, auto-immune diseases;
- cognitive changes;
- people who perform some exercise;
- having a pacemaker;
- people under the age of 30 and more than 55 years;
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 |
|---|---|---|
| Active PBMTThe Active PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA) will be used. The ACTIV PRO emits 30mW of 905nm, 300mW of 850nm, 200mW of 660nm and 0mW of 455nm light via an electric diode energy source. PBMT will be applied using the direct contact method with light pressure on the skin. The PBMT application time will be 120 seconds per region and the total time will vary according to the number of regions to be treated. Only the painful regions on that day will be treated (according widespread pain index [WPI] ), which can comprise a minimum of 3 and a maximum of 18 regions in total. The dose used for applications during the treatment will be 60 Joules (J) per region. The total dose might vary between patients and each session. | Device | Active PBMT |
| Placebo PBMTThe placebo PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA). The ACTIV PRO emits 905nm, and 850nm via an electric diode energy source with outputs to 0%. The 660nm light via an electric diode energy source with outputs to >1% to appear like the active comparator. PBMT will be applied using the direct contact method with light pressure on the skin. The placebo PBMT application time will be 115 seconds per region and the total time will vary according to the number of regions to be treated. Only the painful regions on that day will be treated (according WPI), which can comprise a minimum of 3 and a maximum of 18 regions in total. The dose used for applications during the treatment will be 0 Joules (J) per region. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). | Device | Placebo PBMT |
Primary outcome
Degree of pain rating - change of TCP (tender point count)
Time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Reduction of the tender point count (TCP) where they have experienced pain as reported on Fibromyalgia Impact Questionnaire (FIQ).
3 secondary outcomes
Pain intensity - VAS
Time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Patient satisfaction - Likert Scale
Time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Adverse events
Time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
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 Jun 2021.
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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.
Ernesto Cesar Pinto Leal Junior, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active PBMT in people with Fibromyalgia, run by University of Nove de Julho 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 14 inclusion and 8 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 Jun 2021. 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?
Degree of pain rating - change of TCP (tender point count) (time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.). 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 Jun 2021.