tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients

NCT04050254 | Completed

• 1 other identifier: tDCS+ET-Fibromyalgia
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia

Keywords

tDCS; Therapeutic exercise; Referred pain; Central sensitization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Fibromyalgia Impact Quality-of-Life

  Baseline; immediately after intervention; 1-month after intervention

• Anxiety

  Baseline; immediately after intervention; 1-month after intervention

• Pain catastrophizing

  Baseline; immediately after intervention; 1-month after intervention

• Depression

  Baseline; immediately after intervention; 1-month after intervention

Other Outcomes (1)

• Blinding

  Immediately after intervention

Study Arms (3)

Real tDCS + exercise

EXPERIMENTAL

Transcranial direct current stimulation combined with therapeutic exercise

Device: Real tDCS; Device: Therapeutic exercise

Sham tDCS + exercise

SHAM COMPARATOR

Sham transcranial direct current stimulation combined with therapeutic exercise

Device: Sham tDCS; Device: Therapeutic exercise

Control

NO INTERVENTION

No treatment.

Interventions

Real tDCS DEVICE

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.

Real tDCS + exercise

Sham tDCS DEVICE

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.

Sham tDCS + exercise

Therapeutic exercise DEVICE

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.

Real tDCS + exercise; Sham tDCS + exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

Hospital General Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

Location

Related Publications (1)

• 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.

  PMID: 35331718 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain, Referred

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: August 8, 2019
• Study Start: September 2, 2019
• Primary Completion: March 27, 2020
• Study Completion: March 27, 2020
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

ES (1)