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TDCS and Tele-rehabilitation Exercise in Fibromyalgia

ConditionFibromyalgia Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorUniversity of Valladolid

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Severe psychiatric disorders.

Uncontrolled cardiovascular, respiratory, metabolic, neurological, rheumatic, or hepatic diseases.

Concurrent chronic inflammatory or autoimmune disease.

Contraindications to physical activity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anodal tDCS over M1

    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.

  • Anodal tDCS over DLPFC

    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

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Anodal tDCS over M1 + telerehabilitationExperimental treatment 2 interventions
Group B: Anodal tDCS over DLPFC + telerehabilitationExperimental treatment 2 interventions
Group C: sham-tDCS + telerehabilitationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will indicate their pain intensity by placing a perpendicular mark on a 100 mm straight line, where the left end represents \'no pain\'; and the right end represents \'the worst imaginable pain\'. Pain intensity is quantified by measuring the distance in mm from the left end of the line using a ruler.

Time frame
At pre-intervention, at weeks 12 and 24.

Secondary outcomes

1

Pain mechanosensitivity

Pain mechanosensitivity will be assessed by summing the pressure pain thresholds at the 18 tender points described by the ACR in 1990 for the diagnosis of fibromyalgia. The pressure pain threshold is defined as the minimum pressure required to elicit pain. An algometer will be used for measurement. Incremental pressure will be applied at a rate of 1 kg/s at each point until the participant reports the onset of minimal pain. Three measurements will be taken at each point, with a 30-second interval between each. The average of the three measurements will be used to calculate the total sum. The order of measurement for each tender point will be consistent across all participants.

Time frame
At pre-intervention, at weeks 12 and 24.
2

Fatigue

Fatigue will be measured using the Spanish version of the Multidimensional Fatigue Inventory. This scale includes five dimensions: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Each dimension provides a score from 4 to 20, where higher scores indicate greater fatigue.

Time frame
At pre-intervention, at weeks 12 and 24.
3

Sleep Quality

Sleep Quality: Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The minimum score is 0 and the maximum is 21 points, with higher scores indicating poorer sleep quality

Time frame
At pre-intervention, at weeks 12 and 24.
4

Pain Catastrophizing

Pain Catastrophizing: Pain catastrophizing will be assessed using the Spanish version of the Pain Catastrophizing Scale. It has a minimum score of 0 and a maximum score of 52 points, with higher scores indicating greater catastrophizing thoughts about pain.

Time frame
At pre-intervention, at weeks 12 and 24.

Other outcomes

1

Exercise intensity

Exercise intensity will be recorded after each session by Google Forms.

Time frame
At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12.
2

Adverse events

Adverse events will be recorded after each session through Google Forms.

Time frame
At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Valladolid

Lead sponsor

Source ClinicalTrials.gov

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