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Completed

NCT Number: NCT04836325

Effect of Transcranial Static Magnetic Field Stimulation in Fibromyalgia Syndrome

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla

Seville, 41009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transcranial static magnetic field stimulation (tSMS)

Procedure

The intervention group will receive a treatment of tSMS in the primary motor cortex.

Sham transcranial static magnetic field stimulation

Procedure

The placebo group will receive a dummy treatment

Primary outcomes

  1. Change from Self-reported pain intensity

    Time frame: 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)

    Self-reported pain intensity evaluated by the Visual Analogue Scale (VAS).

  2. Change from Self-reported quality of life

    Time frame: 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)

    Self-reported quality of life evaluated by the Fibromyalgia Impact Questionnaire (FIQ).

Secondary outcomes

  1. Change from Self-reported catastrophizing

    Time frame: 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)

    Self-reported catastrophizing evaluated by the Pain Catastrophizing Scale: 13 items, using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), the worse the result the higher the score.

  2. Change from Confidence in the treatment

    Time frame: 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)

    Confidence in the treatment evaluated by the Patient Global Impression of Change.

  3. Change from Global health

    Time frame: 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)

    Self-reported Global health evaluated by the Short form-36 (SF-36).

  4. Change from Cognitive impairment

    Time frame: 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)

    Cognitive impairment evaluated by the Multidimensional Inventory of Subjective Cognitive Impairment.

  5. Change from Depression

    Time frame: 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)

    Depression Evaluated by the Hospital Anxiety and Depression Scale: 14 items, 7 for depression and 7 for anxiety. Each item had been answered by the patient on a four-point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression, the worse the result the higher the score.

  6. Change from Sleep

    Time frame: 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)

    Change from Sleep evaluated by the Medical Outcomes Study Sleep Scale:12 Likert-type items with 6 degrees of response (from 1-always to 6-never). For its interpretation, a gross estimate of the amount of sleep is obtained (item 2) and scores in the different subscales. The direct scores are transformed into a scale from 0 to 100, with no cut-off points; the higher the score, the greater the intensity of the concept evaluated.

  7. Change from Physical activity

    Time frame: 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)

    Change from Physical activity evaluated by the International Physical Activity Questionnaire.

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Effect of Transcranial Static Magnetic Field Stimulation Over the Primary Motor Cortex in Fibromyalgia Syndrome: A Randomized Controlled Pilot Study

Acronym: TSMFS-FMS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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