Status:
RECRUITING
Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
Lead Sponsor:
Ahmed Alshimy
Conditions:
Fibromyalgia Syndrome
Eligibility:
All Genders
25-35 years
Phase:
NA
Brief Summary
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; ...
Detailed Description
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 rece...
Eligibility Criteria
Inclusion
- Patients fibromyalgia from both genders.
- The duration of fibromyalgia is more than 6 month (all patients with history of cervical or lumbar pain) and following diagnosis of FM using the 2016 revised FM criteria, on the basis of the ACR-2010 criteria.
- Their ages will be ranged from 25-35 years old.
- They will be medically stable and have sufficient cognitive abilities that enable them to understand and follow instruction according to Montreal Cognitive Assessment (MoCA) \>26.
Exclusion
- Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease
- Pacemaker
- Spinal fusion-cervical or lumbar
- Metal implants in the spine
- Pregnancy
- Epilepsy
- Severe psychiatric disorder or alcohol and drug abuse.
- Unstable medical condition which could compromise the participant's welfare or confound the study results.
- Uncontrolled blood pressure or diabetes
- Visual or auditory problems.
- Active inflammatory conditions
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 3 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06539793
Start Date
September 1 2024
End Date
July 3 2025
Last Update
August 6 2024
Active Locations (1)
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1
Al Ryada University for Science and Technology
Sadat, Menoufia, Egypt