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Completed

NCT Number: NCT04050254

tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in referred pain area after suprathreshold pressure stimulation from baseline to post-treatment

    Time frame: Baseline; immediately after intervention; 1-month 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.

    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).

  2. Change in pain intensity from baseline to post-treatment

    Time frame: Baseline; immediately after intervention; 1-month 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

Secondary outcomes

  1. Fibromyalgia Impact Quality-of-Life

    Time frame: Baseline; immediately after intervention; 1-month after intervention

    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.

  2. Anxiety

    Time frame: Baseline; immediately after intervention; 1-month after intervention

    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.

  3. Pain catastrophizing

    Time frame: Baseline; immediately after intervention; 1-month after intervention

    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.

  4. Depression

    Time frame: Baseline; immediately after intervention; 1-month after intervention

    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.

Other outcomes

  1. Blinding

    Time frame: Immediately after intervention

    Blinding of subjects and researchers will be assessed using the James Index.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2019
Registry last updated
Jun 11, 2021

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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