Clinical trial NCT04050254: tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
Official title: Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Fibromyalgia Patients. A Triple-blinded, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: tDCS
Therapeutic exercise
Referred pain
Central sensitization
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in referred pain area after suprathreshold pressure stimulation from baseline to post-treatment
timeFrame: Baseline; immediately after intervention; 1-month after intervention
measure: Change in pain intensity from baseline to post-treatment
timeFrame: Baseline; immediately after intervention; 1-month after intervention
Secondary outcomes:
measure: Fibromyalgia Impact Quality-of-Life
timeFrame: Baseline; immediately after intervention; 1-month after intervention
measure: Anxiety
timeFrame: Baseline; immediately after intervention; 1-month after intervention
measure: Pain catastrophizing
timeFrame: Baseline; immediately after intervention; 1-month after intervention
measure: Depression
timeFrame: Baseline; immediately after intervention; 1-month after intervention
Other outcomes:
measure: Blinding
timeFrame: Immediately after intervention
Locations:
city: Talavera De La Reina
country: Spain
facility: Hospital General Nuestra Señora del Prado
state: Toledo
Study officials:
References:
citation: 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.