Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Technion, Israel Institute of Technology | OTHER |
| Rambam Health Care Campus | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Stimulation of the Primary Motor Cortex (M1) Combined With Aerobic Activity. | Active Comparator | low current electrical stimulation to Motor cortex for 3 weeks. |
|
| Direct Stimulation the Prefrontal Cortex Combined With Aerobic Activity | Active Comparator | with low current electrical stimulation to Prefrontal cortex for 3 weeks. |
|
| Shame Stimulation Combined With Aerobic Activity | Sham Comparator | Shame low current electrical stimulation to cortex for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct Stimulation Prefrontal Cortex | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas Numeric pain rating scale. | 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) | 3 months |
| 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. | 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 | 3 months |
| 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. | 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 | 3 months |
| 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 | 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 | 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahak Yariv | Contact | 972-4-6495590 | yariv_sh@clalit.org.il |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Shame cortex stimulation | Device | 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. |
|
| Direct Stimulation to Motor Cortex | Device | 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. |
|
| erobic physical activity | Behavioral | 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), |
|
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided