Electric Shock, Fibromyalgia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDirect Stimulation Prefrontal Cortex
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.
DEVICEShame cortex stimulation
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.
DEVICEDirect Stimulation to Motor Cortex
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.
BEHAVIORALerobic physical activity
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),
Sponsors
Technion, Israel Institute of Technology
Rambam Health Care Campus
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed Fibromyalgia * Pain scale level of 4 or higher * Fail to achieve adequate pain relief with Fibromyalgia treatments * stable Fibromyalgia treatment for at least 4 weeks. * Ability to perform aerobic exercise
Exclusion criteria
* Other Causes of pain * Psychotic disorder * Severe Depression * Cognitive disorder * Drug or alcohol abuse in the last 6 months * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas Numeric pain rating scale. | 3 months | Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation to blood stimulation. Based on: Numeric pain rating scale (score range from 1 to 10) |
| Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation Adult sensory profile test Raw score. | 3 months | Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation to blood stimulation. Based on: Adult sensory profile test Raw score |
| Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to The Montreal Cognitive Assessment (MoCA) score. | 3 months | Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation to The Montreal Cognitive Assessment (MoCA) score. Based on: The Montreal Cognitive Assessment (MoCA) score |
| Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to Generalized Anxiety Disorder 7-Item Scale | 3 months | Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation to blood stimulation. Based on: The Generalized Anxiety Disorder 7-Item Scale |
Contacts
Primary ContactShahak Yariv
Outcome results
None listed