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tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Real tDCS
Sham tDCS
Therapeutic exercise
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring tDCS, Therapeutic exercise, Referred pain, Central sensitization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Hospital General Nuestra Señora del Prado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Real tDCS + exercise

Sham tDCS + exercise

Control

Arm Description

Transcranial direct current stimulation combined with therapeutic exercise

Sham transcranial direct current stimulation combined with therapeutic exercise

No treatment.

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 14, 2019
Last Updated
June 10, 2021
Sponsor
University of Castilla-La Mancha
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1. Study Identification

Unique Protocol Identification Number
NCT04050254
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
March 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
tDCS, Therapeutic exercise, Referred pain, Central sensitization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real tDCS + exercise
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation combined with therapeutic exercise
Arm Title
Sham tDCS + exercise
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation combined with therapeutic exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment.
Intervention Type
Device
Intervention Name(s)
Real tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Therapeutic exercise
Intervention Description
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 Outcome Measure Information:
Title
Change in referred pain area after suprathreshold pressure stimulation from baseline to post-treatment
Description
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).
Time Frame
Baseline; immediately after intervention; 1-month after intervention
Title
Change in pain intensity from baseline to post-treatment
Description
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
Time Frame
Baseline; immediately after intervention; 1-month after intervention
Secondary Outcome Measure Information:
Title
Fibromyalgia Impact Quality-of-Life
Description
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.
Time Frame
Baseline; immediately after intervention; 1-month after intervention
Title
Anxiety
Description
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.
Time Frame
Baseline; immediately after intervention; 1-month after intervention
Title
Pain catastrophizing
Description
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.
Time Frame
Baseline; immediately after intervention; 1-month after intervention
Title
Depression
Description
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.
Time Frame
Baseline; immediately after intervention; 1-month after intervention
Other Pre-specified Outcome Measures:
Title
Blinding
Description
Blinding of subjects and researchers will be assessed using the James Index.
Time Frame
Immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Hospital General Nuestra Señora del Prado
City
Talavera De La Reina
State/Province
Toledo
ZIP/Postal Code
45600
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35331718
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.
Results Reference
derived

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tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients

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