UHCDS a-tDCS + TE in Fibromyalgia Patients

December 13, 2023 updated by: University of Castilla-La Mancha

Efficacy of Unihemispheric Concurrent Dual-Site Anodal Transcranial Direct Current Stimulation Combined With Therapeutic Exercise on Pain in Fibromyalgia

The present study aims to investigate the effect of a Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise on pain in subjects with FM.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Fibromyalgia (FM) syndrome is characterized as a cardinal symptom of chronic pain. It is one of the rheumatic diseases with the greatest impact on quality of life.

Although the etiology and pathophysiology are not yet completely clear, FM is related to specific changes in brain activity, such as a decrease in blood flow in the thalamus, caudate nucleus and pons tegmentum. This could be related to the appearance of a disorder in pain regulation, characterized by an alteration of the sensory and pain process in the central nervous system, due to neuroplastic changes in the neural circuits related to pain. Imaging studies have shown that FM could be associated with functional changes in the brain, such as a reduction in connectivity in efferent pain inhibitory pathways and central sensitization in afferent pain pathways, resulting in an increase in pain perception.

The most common FM treatment guidelines recommend aerobic exercise as the only non-pharmacological therapy with level A recommendation in the treatment of FM. In the same way, it concludes that it is more than recommended to combine therapies assuming synergistic effects between them.

Neuromodulation treatments with transcranial direct current stimulation (tDCS) have been shown to induce significant analgesia in FM through the modification of sensory processing of pain by thalamic inhibitory circuits. To date, the few studies that have combined tDCS and therapeutic exercise in FM have applied tDCS to the primary motor cortex (M1) in isolation. Currently, several studies conclude that Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation (UHCDS a-tDCS) on the dorsolateral prefrontal cortex (DLPFC) and M1 produces a 50% greater modulation of corticospinal excitability in healthy subjects. To date, there is no study that has evaluated the effectiveness of this novel application of tDCS in subjects with FM on pain.

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Toledo
      • Talavera De La Reina, Toledo, Spain, 45600
        • Hospital General Nuestra Señora del Prado
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 65 years.
  • Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
  • Usual pain intensity of 4 or more points on a visual analogue scale.
  • Able to participated in a therapeutic exercise program.
  • Understanding of spoken and written Spanish.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Metallic implants in the head.
  • Tumor, trauma or surgery in the brain.
  • Epilepsy or stroke.
  • History of substance abuse in the last 6 months.
  • Use of carbamazepine in the last 6 months.
  • Diagnosed psychiatric pathology.
  • Rheumatic pathology not medically controlled.
  • Coexisting autoimmune pathology.
  • Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real UHCDS a-TDCS + Therapeutic Exercise
Real unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise.
Device: Real UHCDS a-tDCS
Real UHCDS a-tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for ten sessions (three sessions per week in weeks 1 and 2; and one session per week in weeks 3, 4, 5 and 6). UHCDS a-tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps.
Device: Therapeutic exercise
The therapeutic exercise program will include aerobic exercise and muscle strengthening in the same days as UHCDS a-tDCS. The program will last 30-45 minutes.
Sham Comparator: Sham UHCDS a-TDCS + Therapeutic Exercise
Sham unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise.
Device: Therapeutic exercise
The therapeutic exercise program will include aerobic exercise and muscle strengthening in the same days as UHCDS a-tDCS. The program will last 30-45 minutes.
Device: Sham UHCDS a-tDCS
Sham UHCDS a-tDCS (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for ten sessions (three sessions per week in weeks 1 and 2; and one session per week in weeks 3, 4, 5 and 6). Sham tDCS will be applied for the same time than real UHCDS a-tDCS.
Active Comparator: Therapeutic Exercise
Therapeutic Exercise.
Device: Therapeutic exercise
The therapeutic exercise program will include aerobic exercise and muscle strengthening in the same days as UHCDS a-tDCS. The program will last 30-45 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity.
Time Frame: Baseline; inmediately after intervention; 3-months after intervention.
It will be measured with a visual analog scale (VAS) of 100 millimeters in length. The subject has to indicate the level of pain he feels, being 0 the absence of pain and 100 the maximum imaginable.
Baseline; inmediately after intervention; 3-months after intervention.
Referred pain area after suprathreshold pressure stimulation.
Time Frame: Baseline; inmediately after intervention; 3-months after intervention.
A pressure algometer (Force Ten™, Wagner Instruments, USA) will be used. It will be performed on the infraspinatus muscle (point equidistant between the midpoint of the spine of the scapula, the inferior angle of the scapula and the midpoint of the medial border of the scapula) at a constant suprathreshold pressure (20% above the pressure pain threshold) for 60 seconds.
Baseline; inmediately after intervention; 3-months after intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety.
Time Frame: Baseline; inmediately after intervention; 3-months after intervention.
The version adapted to Spanish from the State Scale (STAI-ES) of the State-Trait Anxiety Inventory (STAI) will be used. STAI-ES ranges from 0 to 60 points, with higher values indicating higher levels of anxiety.
Baseline; inmediately after intervention; 3-months after intervention.
Pain catastrophizing.
Time Frame: Baseline; inmediately after intervention; 3-months after intervention.
The Spanish version of the Pain Catastrophizing Scale (PCS) will be used. PCS ranges from 0 to 52 points, with higher values indicating higher levels of catastrophizing.
Baseline; inmediately after intervention; 3-months after intervention.
Depression.
Time Frame: Baseline; inmediately after intervention; 3-months after intervention.
The adaptation to the Spanish of Beck Depression Inventory II (BDI-II) will be used. BDI-II ranges from 0 to 63 points, with higher values indicating higher levels of depression.
Baseline; inmediately after intervention; 3-months after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Investigators

  • Study Director: Rubén Arroyo Fernández, PhD, University of Castilla-La Mancha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 8, 2024

Primary Completion (Estimated)

June 11, 2024

Study Completion (Estimated)

July 9, 2024

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCDS a-tDCS+ TE FM Pain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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