NCT Number: NCT06263972
The goal of this study is to demonstrate the effectiveness of treating fibromyalgia using combination of electrical stimulation with aerobic activity.
Participants will be randomly assigned to stimulation in a ratio of 1:1:1. 120 participants (40 in each group). The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation for 3 weeks.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Fibromyalgia is a disorder of unknown origin that causes widespread pain, fatigue, sleep disorders, cognitive disorders, depression and anxiety. Today, the treatments for fibromyalgia are limited in their effectiveness in most cases. Previous works have demonstrated that the self-regulation ability among those dealing with fibromyalgia is impaired, and their quality of life is poor.
Therapy using low current electrical stimulation is considered an effective, safe and non-invasive means of treating various disorders including treatment of depression, neurological rehabilitation and various pain syndromes.
A number of works have demonstrated the effectiveness of treating fibromyalgia using stimulation using low electrical current , and it has also been demonstrated that a combination of electrical stimulation with aerobic activity improved the results, together with each of the treatments separately. There are several areas that can be stimulated including the primary motor area (M1) and the prefrontal area , however, the studies performed were limited to a relatively small number of subjects, and no direct comparison was made between the different stimulation locations.
For the study, male and female patients dealing with fibromyalgia will be recruited from the hospital clinics or those who will be referred by the attending physician, or will respond to recruitment notices, in total we intend to recruit 120 participants (40 in each group). The patients will be randomly assigned to real stimulation for each of the areas or to blood stimulation in a ratio of 1:1:1. The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation for 3 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation to prefrontal cortex for 3 weeks.
The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with shame low current electrical stimulation to cortex for 3 weeks.
The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation to Motor cortex for 3 weeks.
Aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment),
Time frame: 3 months
Study objectives:
Based on:
Numeric pain rating scale (score range from 1 to 10)
Time frame: 3 months
Study objectives:
Based on:
Adult sensory profile test Raw score
Time frame: 3 months
Study objectives:
Based on:
The Montreal Cognitive Assessment (MoCA) score
Time frame: 3 months
Study objectives:
Based on:
The Generalized Anxiety Disorder 7-Item Scale
Contact information is provided by the study sponsor or research team.
HaEmek Medical Center, Israel
Other
Comparison of the Efficacy of Transcranial Direct Current Stimulation (tDCS) of the Primary Motor Cortex (M1) or the Prefrontal Cortex Combined With Aerobic Activity for Alleviation of Fibromyalgia Symptoms and on Improving Self-Regulation and Quality of Life- a Randomized, Double Blinded Controlled Prospective Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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