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

NCT04322812 | Completed FDA Device

• 1 other identifier: 2.732.062
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

Photobiomodulation Therapy; Low-level Laser Therapy; Fibromyalgia; Pain intensity

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Pain intensity - VAS

  3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.

• Patient satisfaction - Likert Scale

  3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.

• Adverse events

  3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.

Study Arms (2)

Active PBMT

ACTIVE COMPARATOR

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

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.

Device: Placebo PBMT

Interventions

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.

Active PBMT

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).

Placebo PBMT

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Multi Radiance Medical: collaborator

Study Sites (1)

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ernesto Cesar Pinto Leal Junior, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: March 31, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

BR (1)