Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Fibromyalgia

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

March 31, 2020

Primary Completion Date

October 30, 2020

Study Completion Date

October 30, 2020

Conditions
Fibromyalgia
Interventions
DEVICE

Active PBMT

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.

DEVICE

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).

Trial Locations (1)

01504-001

Laboratory of Phototherapy and Innovative Technologies in Health, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Multi Radiance Medical

INDUSTRY

lead

University of Nove de Julho

OTHER