tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050254
• Other study ID #: tDCS+ET-Fibromyalgia
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: March 27, 2020

Study information

• Verified date: June 2021
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 27, 2020
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital General Nuestra Señora del Prado	Talavera De La Reina	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blinding	Blinding of subjects and researchers will be assessed using the James Index.	Immediately after intervention
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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