tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients

Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Fibromyalgia Patients. A Triple-blinded, Randomized, Placebo-controlled Trial

The purpose of this study is to assess the effects on pain of transcranial direct current stimulation combined with therapeutic exercise in fibromyalgia patients.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Real tDCS; Device: Therapeutic exercise; Device: Sham tDCS

Detailed Description

Fibromyalgia is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated. Perhaps this is why its therapeutic approach is refractory to current treatments.

Based on the theory that fibromyalgia is characterized by a sensitization at the level of the central nervous system that leads to an increase in the perception of pain, any therapeutic approach aimed at modulating the central nervous system may be beneficial. Electrical stimulation with transcranial direct current (tDCS) is among these techniques.

In the same way, therapeutic exercise has shown to have, like the tDCS, a beneficial effect on pain in different chronic pathologies.

The present study aims to investigate the effect on pain of a combination therapy of tDCS and therapeutic exercise in patients with fibromyalgia.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 65 years.
• Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
• Normal pain intensity of 4 or more points on a visual analog 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.
• Severe depression (Beck Depression Index II of 29 or more).
• Diagnosed psychiatric pathology.
• Rheumatic pathology not medically controlled.
• Coexisting autoimmune pathology.
• Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No treatment.
Experimental: Real tDCS + exercise; Transcranial direct current stimulation combined with therapeutic exercise	Device: Real tDCS; Real tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.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 for five sessions on alternate days. The program will include exercises and will last 30-45 minutes.
Sham Comparator: Sham tDCS + exercise; Sham transcranial direct current stimulation combined with therapeutic exercise	Device: Therapeutic exercise; The therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days. The program will include exercises and will last 30-45 minutes.; Device: Sham tDCS; Sham current (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days. Sham tDCS will be applied for the same time than real tDCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in referred pain area after suprathreshold pressure stimulation from baseline to post-treatment	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. After the stimulation, the subject should draw the induced pain area on a digital bodychart using the Navigate Pain application (Navigate Pain, Aalborg University, Denmark).	Baseline; immediately after intervention; 1-month after intervention
Change in pain intensity from baseline to post-treatment	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; immediately after intervention; 1-month after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibromyalgia Impact Quality-of-Life	It will be measured with the version adapted to the Spanish of the Fibromyalgia Impact Questionnaire (FIQ). The scale ranges from 0 to 100. Higher values represent a worse result.	Baseline; immediately after intervention; 1-month after intervention
Anxiety	The version adapted to Spanish from the State Scale (STAI-ES) of the State-Trait Anxiety Inventory (STAI) will be used. The scale ranges from 0 to 60. Higher values represent a worse result.	Baseline; immediately after intervention; 1-month after intervention
Pain catastrophizing	The Spanish version of the Pain Catastrophizing Scale (PCS) will be used. The scale ranges from 0 to 52. Higher values represent a worse result.	Baseline; immediately after intervention; 1-month after intervention
Depression	The adaptation to the Spanish of Beck Depression Inventory II will be used. The scale ranges from 0 to 63. Higher values represent a worse result.	Baseline; immediately after intervention; 1-month after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blinding	Blinding of subjects and researchers will be assessed using the James Index.	Immediately after intervention

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha

Publications and helpful links

General Publications

• Arroyo-Fernandez R, Avendano-Coy J, Velasco-Velasco R, Palomo-Carrion R, Bravo-Esteban E, Ferri-Morales A. Effectiveness of Transcranial Direct Current Stimulation Combined With Exercising in People With Fibromyalgia: A Randomized Sham-Controlled Clinical Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1524-1532. doi: 10.1016/j.apmr.2022.02.020. Epub 2022 Mar 22.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): March 27, 2020
• Study Completion (Actual): March 27, 2020

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: tDCS; Therapeutic exercise; Referred pain; Central sensitization
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: tDCS+ET-Fibromyalgia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No