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| Name | Class |
|---|---|
| Multi Radiance Medical | INDUSTRY |
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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.
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 investigators will analyze: degree of pain rating (tender point count), pain intensity, patient satisfaction and adverse events
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active PBMT | Active Comparator | Active PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions. |
|
| Placebo PBMT | Placebo Comparator | Placebo PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active PBMT | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity - VAS | Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS). | 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment. |
| Patient satisfaction - Likert Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernesto Cesar Pinto Leal Junior, PhD | University of Nove de Julho | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Phototherapy and Innovative Technologies in Health | São Paulo | 01504-001 | Brazil |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 4, 2021 | Aug 30, 2021 | 8 |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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A researcher will program the device (placebo or PMBT) and will be instructed not to inform the patients or other researchers as to the type of treatment (PMBT or placebo). Therefore, the researcher responsible for the treatment, the investigator and the outcome assessor will be blinded to the type of treatment being administered to the patients. 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 (placebo or PBMT).
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| Placebo PBMT | Device | 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). |
|
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.
| 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment. |
| Adverse events | Adverse events will be measured by report. | 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment. |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |