Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

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.
      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
    

Intervention name(s): Active PBMT; Placebo PBMT
Intervention type(s): Device; Device
Intervention description(s): 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.; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Photobiomodulation Therapy; Low-level Laser Therapy; Fibromyalgia; Pain intensity