tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients

University of Castilla-La Mancha

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Therapeutic exercise; Device: Sham tDCS; Device: Real tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04050254

tDCS+ET-Fibromyalgia

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Real tDCS + exercise

Experimental group

Description:

Transcranial direct current stimulation combined with therapeutic exercise

Treatment:

Device: Therapeutic exercise

Device: Real tDCS

Sham tDCS + exercise

Sham Comparator group

Description:

Sham transcranial direct current stimulation combined with therapeutic exercise

Treatment:

Device: Therapeutic exercise

Device: Sham tDCS

Control

No Intervention group

Description:

No treatment.