NCT06539793

Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ahmed Alshimy · Academic / Other
• Sex: All
• Age: 25 Years – 35 Years
• Healthy volunteers: Not accepted

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; the prevalence is highest in age the range of 40-60 years.

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 receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks.

Conditions

• Fibromyalgia Syndrome

Interventions

Type	Name	Description
OTHER	Aerobic Exercises	Treadmill 20 minutes including 5 minutes warm up and 5 minutes cool.
OTHER	Transcutaneous electrical nerve stimulation	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

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-04-04
• Completion: 2025-07-03
• First posted: 2024-08-06
• Last updated: 2024-08-06

Locations

1 site across 1 country: Egypt