Clinical trial NCT04836325: Effect of Transcranial Static Magnetic Field Stimulation in Fibromyalgia Syndrome
Official title: Effect of Transcranial Static Magnetic Field Stimulation Over the Primary Motor Cortex in Fibromyalgia Syndrome: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: transcranial static magnetic field stimulation
fibromyalgia
pain
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to know if the transcranial static magnetic field stimulation (tSMS) reduces the perception of pain in patients with fibromyalgia and its effect on health-related quality of life. In addition, it will seek to limit the parameters necessary to achieve efficiency with the technique.

Detailed description: Background:

Various non-invasive brain stimulation techniques have been successfully tested in fibromyalgia syndrome (FMS). Transcranial static magnetic field stimulation (tSMS) is a new, portable and inexpensive non invasive brain stimulation (NIBS) technique that has shown security, biological effects, and therapeutical effects in some pathologies. Some studies have studied its effect in pain central processing, our aim is to study its effect on FMS. The safety that tSMS has demonstrated in several clinical trials opens doors to future clinical trials that will extend its clinical utility.

Objectives:

To investigate the effect of tSMS on pain in patients with FMS, using subjective and objective assessment measures. Identify dose response to the treatment to limit the parameters required to achieve effectiveness with the technique.

Eligibility criteria: Inclusion Criteria:

* Formal diagnosis of fibromyalgia syndrome (FMS).
* No change in the last 4 weeks on their standard treatment.
* They must have pain for more than 6 months (at least 4 on the VAS scale).
* Score on the fibromyalgia impact questionnaire (FIQ) greater than 39.

Exclusion Criteria:

* Presence of concomitant autoimmune or hematologic diseases.
* Neuropsychiatric disorders.
* Pacemakers or neurostimulators implants.
* Substance abuse or other pathologies that can explain chronic pain.
* Pregnant or lactating women.
* Those who are receiving any other type of physiotherapy treatment.

Primary outcomes:
measure: Change from Self-reported pain intensity
timeFrame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week) and 3 months from the last session (16th week)
measure: Change from Self-reported quality of life
timeFrame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
Secondary outcomes:
measure: Change from Self-reported catastrophizing
timeFrame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
measure: Change from Confidence in the treatment
timeFrame: After the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
measure: Change from Global health
timeFrame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
measure: Change from Cognitive impairment
timeFrame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
measure: Change from Depression
timeFrame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
measure: Change from Sleep
timeFrame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
measure: Change from Physical activity
timeFrame: After the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week) and 3 months from the last session (16th week)
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
Study officials:
affiliation: University of Seville
name: JOSE-JESUS JIMENEZ-REJANO, PhD
role: STUDY_DIRECTOR
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