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Fibromyalgia is the third most common musculoskeletal condition in terms of prevalence, after lumbar pain and osteoarthritis. Its prevalence is around 2-4 % and is more frequent in women than in men; the prevalence is highest in age the range of 40-60 years.
Group A (Control Group): Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.
Group B (Study Group): Patients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group (A) | Experimental | Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks. |
|
| Control group (B) | Experimental | Patients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercises | Other | Treadmill 20 minutes including 5 minutes warm up and 5 minutes cool. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Numeric Pain Rating Scale | Assessment of pain intensity (0-no pain, 10-most intense pain) | 4 weeks |
| Biochemical analysis | Assessment of pain intensity through the change of blood cortisol level, plasma cytokine level, antinuclear antibody (ANA) level. Blood samples will be taken between the hours of 08:00-09:00 in the morning. Two blood samples will be taken from the patients before and after treatment. | 4 weeks |
| Fibromyalgia Impact Questionnaire | Assess functional outcome | 4 weeks |
| Pressure Pain Thresholds | Assess pain sensitivity through pressure algometer | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Ryada University for Science and Technology | Recruiting | Sadat | Menoufia | Egypt |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Transcutaneous electrical nerve stimulation | Other | will be applied for all patients, which uses an asymmetrical biphasic alternating current in the continuous mode (pulse duration 100 µs, low frequency). TENS intensity will increase slowly, and patients will be instructed to indicate sensory threshold (ST); then, the intensity are going to increase until the sensation perceived as "strong but comfortable" (SC1). The duration will be for 30 minutes, 3times/ week for 4 weeks |
|
| D009422 |
| Nervous System Diseases |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |