UHCDS a-tDCS + TE in Fibromyalgia Patients

NCT06169748 | Completed

• 1 other identifier: UHCDS a-tDCS+ TE FM Pain
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to investigate the effect of a Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise on pain in subjects with FM.

Conditions

Fibromyalgia

Keywords

Neuromodulation; Therapeutic exercise; Pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity.

  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; inmediately after intervention; 3-months after intervention.

• Referred pain area after suprathreshold pressure stimulation.

  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.

  Baseline; inmediately after intervention; 3-months after intervention.

Secondary Outcomes (3)

• Anxiety.

  Baseline; inmediately after intervention; 3-months after intervention.

• Pain catastrophizing.

  Baseline; inmediately after intervention; 3-months after intervention.

• Depression.

  Baseline; inmediately after intervention; 3-months after intervention.

Study Arms (3)

Real UHCDS a-TDCS + Therapeutic Exercise

EXPERIMENTAL

Real unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise.

Device: Real UHCDS a-tDCS; Device: Therapeutic exercise

Sham UHCDS a-TDCS + Therapeutic Exercise

SHAM COMPARATOR

Sham unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise.

Device: Sham UHCDS a-tDCS; Device: Therapeutic exercise

Therapeutic Exercise

ACTIVE COMPARATOR

Therapeutic Exercise.

Device: Therapeutic exercise

Interventions

Real UHCDS a-tDCS DEVICE

Real UHCDS a-tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for ten sessions (three sessions per week in weeks 1 and 2; and one session per week in weeks 3, 4, 5 and 6). UHCDS a-tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps.

Real UHCDS a-TDCS + Therapeutic Exercise

Sham UHCDS a-tDCS DEVICE

Sham UHCDS a-tDCS (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for ten sessions (three sessions per week in weeks 1 and 2; and one session per week in weeks 3, 4, 5 and 6). Sham tDCS will be applied for the same time than real UHCDS a-tDCS.

Sham UHCDS a-TDCS + Therapeutic Exercise

Therapeutic exercise DEVICE

The therapeutic exercise program will include aerobic exercise and muscle strengthening in the same days as UHCDS a-tDCS. The program will last 30-45 minutes.

Real UHCDS a-TDCS + Therapeutic Exercise; Sham UHCDS a-TDCS + Therapeutic Exercise; Therapeutic Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years.
• Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
• Usual pain intensity of 4 or more points on a visual analogue scale.
• Able to participated in a therapeutic exercise program.
• Understanding of spoken and written Spanish.

You may not qualify if:

• 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.
• Diagnosed psychiatric pathology.
• Rheumatic pathology not medically controlled.
• Coexisting autoimmune pathology.
• Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

Hospital General Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Rubén Arroyo Fernández, PhD

  University of Castilla-La Mancha

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: January 8, 2024
• Primary Completion: July 4, 2024
• Study Completion: August 12, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Locations

ES (1)