TDCS and Tele-rehabilitation Exercise in Fibromyalgia

NCT ID: NCT06616181

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-12-01

Brief Summary

This randomized controlled trial aims to analyze the effects of anodal tDCS applied over the primary motor cortex and dorsolateral prefrontal cortex combined with a tele-rehabilitation exercise program in patients with fibromyalgia. The study will compare these effects with each other and with placebo tDCS on the following variables: pain intensity, pain mechanosensitivity, quality of life, fatigue, anxiety, depression, sleep quality, pain catastrophizing, functional capacity, isometric strength, and exercise adherence.

Secondary objectives include:

• Describing the sociodemographic, clinical, and functional characteristics of fibromyalgia patients.
• Comparing exercise intensity levels between patients receiving tDCS on M1, DLPFC, and placebo stimulation.
• Reporting any adverse effects of the intervention. Adult participants with fibromyalgia will be randomized into three groups: a) anodal tDCS over M1 + telerehabilitation, b) anodal tDCS over DLPFC + telerehabilitation, and c) sham-tDCS + telerehabilitation. The intervention will last for 12 weeks. The telerehabilitation exercise program will include an aerobic phase and a resistance phase, with four intensity levels regulated based on the Borg Rating of Perceived Exertion (0-10). The program will be conducted remotely through phone contact, with materials and videos provided to guide exercise execution. tDCS will be applied once per week for 20 minutes at 2 mA, either over M1 or DLPFC.

The dependent variables-pain intensity, fibromyalgia impact, fatigue, anxiety and depression levels, pain catastrophizing, sleep quality, functional capacity, and isometric muscle strength-will be collected in the week prior to the intervention, the week following the intervention, and 12 weeks after its completion. Additionally, pain intensity, fibromyalgia impact, fatigue severity, anxiety and depression levels, pain catastrophizing, and sleep quality will be evaluated during the 6th week of the intervention.

Exercise intensity, exercise adherence, and any adverse effects related to the intervention will be recorded weekly.

Conditions

Fibromyalgia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Anodal tDCS over M1 + telerehabilitation

tDCS over M1: The anode will be placed over the left M1 (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.

Telerehabilitation Exercise: Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance exercise will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact.

Group Type: EXPERIMENTAL

Anodal tDCS over M1

Intervention Type: DEVICE

The anode will be placed over the left M1 (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.

Exercise telerehabilitation

Intervention Type: BEHAVIORAL

Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance training will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact.

Anodal tDCS over DLPFC + telerehabilitation

tDCS over DLPFC: The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (F3), and the cathode will be positioned over the contralateral supraorbital area (F8). Once the electrodes are positioned, active tDCS will be applied at 2mA for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.

Tele-rehabilitation Exercise: Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance exercise will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact.

Group Type: EXPERIMENTAL

Anodal tDCS over DLPFC

Intervention Type: DEVICE

The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.

Exercise telerehabilitation

Intervention Type: BEHAVIORAL

Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance training will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact.

sham-tDCS + telerehabilitation

Sham tDCS: The same electrode placement protocol used for the active tDCS M1 group will be followed in this group. Stimulation will begin with a 30-second ramp-up to reach an intensity of 2 mA, immediately followed by a 30-second ramp-down to 0 mA. This stimulation will be repeated at the beginning and end of the session. Similar to the active tDCS groups, each session will last 20 minutes.

Telerehabilitation Exercise: Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance exercise will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact.

Group Type: PLACEBO_COMPARATOR

Exercise telerehabilitation

Intervention Type: BEHAVIORAL

Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance training will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact.

Interventions

Anodal tDCS over M1

The anode will be placed over the left M1 (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.

Intervention Type: DEVICE

Anodal tDCS over DLPFC

The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.

Intervention Type: DEVICE

Exercise telerehabilitation

Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance training will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age between 30 and 70 years.
• Medical diagnosis of fibromyalgia.Compliance with the latest diagnostic criteria from the American College of Rheumatology.
• Stable medication for at least 12 weeks prior to the start of the study.
• Ability to use communication technologies, such as smartphones and computers.
• Capacity to participate in an aerobic exercise program.
• Access to the internet.
• Proficiency in oral and written Spanish.
• Signed informed consent

Exclusion Criteria

• Severe psychiatric disorders.
• Uncontrolled cardiovascular, respiratory, metabolic, neurological, rheumatic, or hepatic diseases.
• Concurrent chronic inflammatory or autoimmune disease.
• Contraindications to physical activity.
• Metal implants in the head.
• History of cancer, brain tumor, epileptic episodes, stroke, severe head trauma, or brain surgery.
• Pregnancy or lactation.
• Use of carbamazepine in the past 6 months.
• Changes in medication during the study.
• Participation in other non-pharmacological conservative therapies (e.g., hydrotherapy, electrotherapy, manual therapy, exercise, dry needling) during the study.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valladolid

OTHER

Sponsor Role: lead

Responsible Party

Ignacio Hernando Garijo

PhD physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ignacio Hernando Garijo

Role: CONTACT

ignacio.hernando@uva.es

975129145

Other Identifiers

UValladolid02

Identifier Type: -

Identifier Source: org_study_id