An interventional study of Anodal tDCS over M1 and Anodal tDCS over DLPFC in Fibromyalgia Syndrome, sponsored by University of Valladolid. Not yet recruiting. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by University of Valladolid · Not applicable, Interventional, and Treatment
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:
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →University of Valladolid is the lead sponsor of 34 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Anodal tDCS over M1 · Behavioral: Exercise 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.
Device: Anodal tDCS over DLPFC · Behavioral: Exercise 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.
Behavioral: Exercise telerehabilitation
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.
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.
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.
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.
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.
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.
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.
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.
Isometric Strength
Maximum isometric muscle strength will be measured for elbow flexors and knee extensors by hand-held dynamometry.
Time frame: At pre-intervention, at weeks 12 and 24.
Exercise Adherence
Exercise adherence will be estimated as the percentage of completed sessions out of the 24 scheduled sessions. This will be tracked weekly using Google Forms to record the number of sessions completed.
Time frame: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12.
6-Minute Walk Test
In this test, the distance in meters that the participant can walk at a fast but comfortable pace, without running, within 6 minutes will be measured. Two cones will be placed 20 meters apart in an unobstructed hallway.
Time frame: At pre-intervention, at 12 and 24 weeks.
30-second Chair Stand Test
This test consists of measuring the number of times the participant can stand up and sit down again in a chair without armrests within 30 seconds.
Time frame: At pre-intervention, at weeks 12 and 24.
Fibromyalgia Impact
Fibromyalgia Impact: The impact of fibromyalgia will be measured using the Spanish version of the Revised Fibromyalgia Impact Questionnaire (FIQ-R). The scale ranges from 0 to 100 points, where higher scores indicate a greater impact of fibromyalgia.
Time frame: At pre-intervention, at weeks 12 and 24.
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.
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.
No study locations are listed for this record.
Plan to share: No
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University of Valladolid