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Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
Led by Ahmed Alshimy · Updated on 2024-08-06
40
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Fibromyalgia Syndrome is a common musculoskeletal condition affecting mostly adults aged 40-60, with a higher occurrence in women. Researchers are studying how non-invasive neuromodulation combined with exercises impacts pain biomarkers and functional outcomes in patients aged 25 to 35 with fibromyalgia. The goal is to understand the effects of this treatment approach on pain and overall function. Participants are randomly assigned to one of two groups. One group receives aerobic exercises along with sham non-invasive neuromodulation, while the other group performs the same exercises combined with active non-invasive neuromodulation. Treatments are given three times per week for one hour each session over four weeks. The neuromodulation involves transcutaneous electrical nerve stimulation applied for 30 minutes per session. During the study, participants will undergo assessments including the Numeric Pain Rating Scale, biochemical analysis, the Fibromyalgia Impact Questionnaire, and pressure pain thresholds, all measured after four weeks. These evaluations help track changes in pain and function. The study is double-blinded, and participation includes close monitoring during the treatment period to ensure safety and adherence.
CONDITIONS
Brief Title
Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with fibromyalgia from both genders
- Fibromyalgia duration of more than 6 months
- Age between 25 and 35 years old
- Medically stable with cognitive ability to understand and follow instructions (Montreal Cognitive Assessment score >26)
You will not qualify if you...
- Other neurological diseases such as stroke, multiple sclerosis, Parkinson's disease, or motor neuron disease
- Having a pacemaker
- Spinal fusion in cervical or lumbar regions
- Metal implants in the spine
- Pregnancy
- Epilepsy
- Severe psychiatric disorders or history of alcohol and drug abuse
- Unstable medical conditions affecting welfare or study results
- Uncontrolled blood pressure or diabetes
- Visual or auditory problems
- Active inflammatory conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive aerobic exercises and either sham or active non-invasive neuromodulation three times per week for 4 weeks.
3 sessions per week (each one hour)
Trial Site Locations
Total: 1 location
1
Al Ryada University for Science and Technology
Sadat, Menoufia, Egypt
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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