Study NCT04322812
Effects of Photobiomodulation Therapy in Patients With Fibromyalgia
Submitted Date:  August 4, 2021 (v9)
Quality Control Review Has Not Concluded

Note: The results information displayed below has not completed the quality control (QC) review process. ClinicalTrials.gov must post results information for applicable clinical trials (ACTs) within 30 days of submission, even if the submission has not completed the QC review process. The study sponsor or investigator is responsible for ensuring the results information meets the QC review criteria.

This submission includes brief standardized QC review comments added by the National Library of Medicine (NLM). These comments indicate the location of apparent errors, deficiencies, or inconsistencies. For more information, see the Final Rule (42 CFR Part 11) Information page.


Open or close this module Study Identification
Unique Protocol ID: 2.732.062
Brief Title: Effects of Photobiomodulation Therapy in Patients With Fibromyalgia
Official Title: A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the MR5™ ACTIV PRO LaserShower for the Temporary Relief of Pain Associated With Fibromyalgia
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2021
Overall Status: Completed
Study Start: March 31, 2020
Primary Completion: October 30, 2020 [Actual]
Study Completion: October 30, 2020 [Actual]
First Submitted: March 24, 2020
First Submitted that
Met QC Criteria:
March 24, 2020
First Posted: March 26, 2020 [Actual]
Results First Submitted: August 4, 2021
Results First Submitted that
Met QC Criteria:
Results First Posted: August 31, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: August 31, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Nove de Julho
Responsible Party: Principal Investigator
Investigator: Ernesto Cesar Pinto Leal Junior
Official Title: Full professor
Affiliation: University of Nove de Julho
Collaborators: Multi Radiance Medical
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this clinical study is to determine whether the Multi Radiance® Medical MR5™ ACTIV PRO LaserShower is effective in temporarily relieving pain associated with fibromyalgia.
Detailed Description:

Photobiomodulation (PBM) is rapidly growing as a modality used in physical therapy, chiropractic, sports medicine and increasingly in mainstream medicine to decrease pain, accelerate healing of injuries and wounds and to improve athletic performance and metabolic recovery following exercise. PBM devices have been previously cleared by the Food and Drug Administration (FDA) to treat a wide array of musculoskeletal pain disorders.

Fibromyalgia (FM) syndrome is defined by the American College of Rheumatology (ACR), as chronic widespread pain and tenderness in at least eleven of eighteen specific tender points.

It affects approximately 2-8% of the general population and presents more frequently in females. Some evidence shows that patients with FM experience pain differently from the general population due to dysfunctional pain processing in the central nervous system. Despite increased knowledge about FM, there is currently no cure.

The absence of any definitive treatment has led to a variety of pharmacological and non-pharmacological treatments including medication, exercise, psychotherapy, and physiotherapeutic resources. However, these have typically been of limited success.

Photobiomodulation therapy (PBMT) offers a simple, pain-free, risk-free alternative treatment for FM. PBMT uses light in the wavelength range of 620-1100 nm to stimulate physiological cellular function to reduce pain and inflammation and promote tissue repair. PBMT acts on peripheral neural stimulation and the regulation of microcirculation, interrupting pain mechanisms and promoting analgesia.

Several previous studies have demonstrated the remission of symptoms in patients with FM through use of PBMT, with positive results reported with respect to reduction in pain, muscle spasms, morning stiffness, and total tender point count, with results often demonstrating enduring effects.

It is the goal of this study to conduct a randomized placebo-controlled double-blinded evaluation of the effect on PMBT using the Multi Radiance® Medical MR5™ ACTIV PRO LaserShower to the reduction of pain associated with fibromyalgia.

Open or close this module Conditions
Conditions: Fibromyalgia
Keywords: Photobiomodulation Therapy
Low-level Laser Therapy
Fibromyalgia
Pain intensity
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 90 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Active PBMT
Active PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.
Device: Active PBMT
The Active PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, Ohio, USA). The ACTIV PRO emits 30 mW (milliWatts) of 905 nm (nanometers), 300 mW of 850 nm, 200 mW of 660 nm and 0 mW of 455 nm 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 to the 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 Comparator: Placebo PBMT
Placebo PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.
Device: Placebo PBMT
The placebo PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, Ohio, USA). The ACTIV PRO emits 905 nm, and 850 nm via an electric diode energy source with outputs to 0%. The 660 nm 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 to 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).
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Percentage of Participants Whose Change in Tender Point Count (TPC) Met the Individual Subject Success Criteria
[ Time Frame: Baseline and 3 weeks ]

The subject rates on a 0-10 visual analog scale (VAS) any pain experienced at each of 18 tender points indicated on a diagram of the body. A lower score on the VAS indicates less pain and a higher score indicates greater pain. The total number of tender points with a VAS rating of 3 or above is the Tender Point Count (TPC). The higher the TPC, the more widely dispersed is the pain, and the lower the TPC, the less dispersed is the pain.

Primary outcome is the difference in the proportion of individual subject successes between the active and control group, with individual subject success predefined as an individual decrease in TPC of 20% or greater at study endpoint (3 weeks) relative to baseline. Overall study success was predefined as at least a 30% difference in the proportion of individual subject successes between procedure groups, anticipating about 60% of subjects in the test group and 30% of subjects in the placebo group meeting the individual success criteria.

Secondary Outcome Measures:
1. Change in Pain Rating on the 0-100 Visual Analog Scale (VAS)
[ Time Frame: Baseline and 3 weeks ]

The Visual Analog Scale (VAS) assesses level or degree of pain. It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'. The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time. This marking is measured with a 0 to 100 mm ruler and the number recorded. A negative (-) number change from one evaluation time to the next indicates a decrease in pain level and is positive for the individual and the study. A positive (+) number change indicates an increase in pain level and is negative for the individual and the study.
2. Change in Total Score on the FIbromyalgia Impact Questionnaire (FIQ)
[ Time Frame: Baseline and 3 Weeks ]

The Fibromyalgia Impact Questionnaire (FIQ) is composed of 10 items that assess the impact of fibromyalgia symptoms on an individual's everyday physical functioning such as with respect to work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. Each of the 10 items has a maximum possible score of 10, for a total maximum possible score of 100. Higher scores indicate that the subject's fibromyalgia symptoms have a greater impact on their daily life while lower scores indicate that the subject's fibromyalgia symptoms have a lesser impact on their daily life. The average FM patient scores about 50 on the FIQ, and severely afflicted patients typically score 70 or greater.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
Open or close this module Eligibility
Minimum Age: 30 Years
Maximum Age: 60 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • being female;
  • age between 30 and 60 years;
  • have an ovulatory cycle;
  • height between 1.50 meters (m) and 1.80m, body mass between 50 and 80 kilograms (kg) and body mass index (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 (ACR);
  • had symptoms of fibromyalgia greater than 3 months;
  • Widespread Pain Index (WPI) score > or = to 9, Visual Analogue Scale (VAS) score > or = to 50 Fibromyalgia Impact Questionnaire (FIQ) 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.

Exclusion Criteria:

  • 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.
Open or close this module Contacts/Locations
Study Officials: Ernesto Cesar Pinto Leal Junior, PhD
Principal Investigator
University of Nove de Julho
Locations: Brazil
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, Brazil, 01504-001
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol and Statistical Analysis Plan: Protocol and Statistical Analysis Plan
Document Date: May 30, 2018
Uploaded: 08/04/2021 17:18
File Name: Prot_SAP_000.pdf
Statistical Analysis Plan: Results Report
Document Date: August 9, 2020
Uploaded: 08/04/2021 17:24
File Name: SAP_001.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details
 
Arm/Group Title Active Photobiomodulation Therapy (PBMT) Placebo Photobiomoduation Therapy (PBMT)
Arm/Group Description

Active Photobiomodulation Therapy (PBMT) applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Active PBMT: The Active PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, Ohio, USA). The ACTIV PRO emits 30 mW (milliWatts) of 905 nm (nanometers), 300 mW of 850 nm, 200 mW of 660 nm and 0 mW of 455 nm 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 to the 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 Photobiomodulation Therapy (PBMT) applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Placebo PBMT: The placebo PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, Ohio, USA). The ACTIV PRO emits 905 nm (nanometers), and 850 nm via an electric diode energy source with outputs to 0%. The 660 nm 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 to 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).

Period Title: Overall Study
Started 45 45
Completed 45 45
Not Completed 0 0
Open or close this module Baseline Characteristics
Arm/Group TitleActive PBMTPlacebo PBMTTotal
Arm/Group Description

Active PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Active PBMT: The Active PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA). The ACTIV PRO emits 30mW (milliWatts) of 905nm (nanometers), 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 to the 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 PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Placebo PBMT: 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).

Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Baseline Analysis Population Description [Not Specified]
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed45 Participants45 Participants90 Participants
45.53(7.95)46.96(8.11)46.24(8.04)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed45 Participants45 Participants90 Participants
Female
45
100%
45
100%
90
100%
Male
0
0%
0
0%
0
0%
Race (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed45 Participants45 Participants90 Participants
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
1
2.22%
1
1.11%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
8
17.78%
2
4.44%
10
11.11%
White
37
82.22%
42
93.33%
79
87.78%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed45 Participants45 Participants90 Participants
Brazil
454590
Average Tender Point Count (TPC)
Mean (Standard Deviation)
Unit of measure: tender points
Number Analyzed45 Participants45 Participants90 Participants
15.29(3.08)15.20(2.69)15.25(2.90)
Average Visual Analog Scale (VAS) Pain Rating
Mean (Standard Deviation)
Unit of measure: units on a scale
Number Analyzed45 Participants45 Participants90 Participants
80.64(13.99)74.89(13.54)77.62(13.72)
Average Fibromyalgia Impact Questionnaire (FIQ) score
Mean (Standard Deviation)
Unit of measure: units on a scale
Number Analyzed45 Participants45 Participants90 Participants
79.68(11.05)77.54(11.57)78.61(11.32)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
Open or close this module Outcome Measures
1. Primary Outcome:
Title Percentage of Participants Whose Change in Tender Point Count (TPC) Met the Individual Subject Success Criteria
Description

The subject rates on a 0-10 visual analog scale (VAS) any pain experienced at each of 18 tender points indicated on a diagram of the body. A lower score on the VAS indicates less pain and a higher score indicates greater pain. The total number of tender points with a VAS rating of 3 or above is the Tender Point Count (TPC). The higher the TPC, the more widely dispersed is the pain, and the lower the TPC, the less dispersed is the pain.

Primary outcome is the difference in the proportion of individual subject successes between the active and control group, with individual subject success predefined as an individual decrease in TPC of 20% or greater at study endpoint (3 weeks) relative to baseline. Overall study success was predefined as at least a 30% difference in the proportion of individual subject successes between procedure groups, anticipating about 60% of subjects in the test group and 30% of subjects in the placebo group meeting the individual success criteria.

Time Frame Baseline and 3 weeks
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleActive PBMTPlacebo PBMT
Arm/Group Description

Active PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Active PBMT: The Active PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA). The ACTIV PRO emits 30mW (milliWatts) of 905nm (nanometers), 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 to the 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 PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Placebo PBMT: 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).

Overall Number of Participants Analyzed45 45
Measure Type: Number
Unit of Measure: percentage of individual subject success
86.67 48.89
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionActive PBMT, Placebo PBMT
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.0005
Comments[Not specified]
MethodFisher Exact
Comments[Not specified]
2. Secondary Outcome:
Title Change in Pain Rating on the 0-100 Visual Analog Scale (VAS)
Description The Visual Analog Scale (VAS) assesses level or degree of pain. It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'. The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time. This marking is measured with a 0 to 100 mm ruler and the number recorded. A negative (-) number change from one evaluation time to the next indicates a decrease in pain level and is positive for the individual and the study. A positive (+) number change indicates an increase in pain level and is negative for the individual and the study.
Time Frame Baseline and 3 weeks
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleActive PBMTPlacebo PBMT
Arm/Group Description

Active PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Active PBMT: The Active PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA). The ACTIV PRO emits 30mW (milliWatts) of 905nm (nanometers), 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 to the 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 PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Placebo PBMT: 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).

Overall Number of Participants Analyzed45 45
Mean (Standard Deviation)
Unit of Measure: score on a scale
-42.84(19.26) -17.98(15.82)
3. Secondary Outcome:
Title Change in Total Score on the FIbromyalgia Impact Questionnaire (FIQ)
Description The Fibromyalgia Impact Questionnaire (FIQ) is composed of 10 items that assess the impact of fibromyalgia symptoms on an individual's everyday physical functioning such as with respect to work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. Each of the 10 items has a maximum possible score of 10, for a total maximum possible score of 100. Higher scores indicate that the subject's fibromyalgia symptoms have a greater impact on their daily life while lower scores indicate that the subject's fibromyalgia symptoms have a lesser impact on their daily life. The average FM patient scores about 50 on the FIQ, and severely afflicted patients typically score 70 or greater.
Time Frame Baseline and 3 Weeks

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleActive PBMTPlacebo PBMT
Arm/Group Description

Active PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Active PBMT: The Active PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA). The ACTIV PRO emits 30mW (milliWatts) of 905nm (nanometers), 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 to the 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 PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Placebo PBMT: 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).

Overall Number of Participants Analyzed45 45
Mean (Standard Deviation)
Unit of Measure: score on a scale
-35.79(16.49) -20.83(14.23)
Open or close this module Adverse Events
 
Time Frame 7 weeks
Adverse Event Reporting Description [Not specified]
 
Arm/Group Title Active PBMT Placebo PBMT
Arm/Group Description

Active PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Active PBMT: The Active PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA). The ACTIV PRO emits 30mW (milliWatts) of 905nm (nanometers), 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 to the 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 PBMT applied three times a week (interval of 48 hours approximately), for three consecutive weeks, totalling nine treatment sessions.

Placebo PBMT: 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).

All-Cause Mortality
  Active PBMTPlacebo PBMT
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 0 / 45 (0%)0 / 45 (0%)
Serious Adverse Events
  Active PBMTPlacebo PBMT
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 0 / 45 (0%)0 / 45 (0%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
  Active PBMTPlacebo PBMT
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 10 / 45 (22.22%)7 / 45 (15.56%)
Eye disorders
blurred vision 1 / 45 (2.22%)10 / 45 (0%)0
General disorders
drowsiness 1 / 45 (2.22%)10 / 45 (0%)0
Metabolism and nutrition disorders
weight loss 0 / 45 (0%)01 / 45 (2.22%)1
Musculoskeletal and connective tissue disorders
spasms 1 / 45 (2.22%)10 / 45 (0%)0
Nervous system disorders
palpations and anxiety 0 / 45 (0%)01 / 45 (2.22%)1
Skin and subcutaneous tissue disorders
increased pain 3 / 45 (6.67%)34 / 45 (8.89%)4
itching 2 / 45 (4.44%)20 / 45 (0%)0
redness/warmth 1 / 45 (2.22%)11 / 45 (2.22%)1
Vascular disorders
headache 1 / 45 (2.22%)10 / 45 (0%)0
Indicates events were collected by systematic assessment.
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact:
Name/Official Title:
Andres Godes, Vice President of Operations and Regulatory Affairs
Organization:
Multi Radiance Medical
Phone:
440-542-0761
Email:
agodes@multiradiance.com

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