Neuromodulation's effect on pain and function in fibromyalgia patients
Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
NA · AlRyada University for Science & Technology · NCT06539793
This study is testing if adding a new treatment called neuromodulation to regular exercises can help people with fibromyalgia feel less pain and improve their daily activities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 25 Years to 35 Years |
| Sex | All |
| Sponsor | AlRyada University for Science & Technology (other) |
| Locations | 1 site (Sadat, Menoufia) |
| Trial ID | NCT06539793 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of neuromodulation on pain biomarkers and functional outcomes in patients diagnosed with fibromyalgia syndrome. Participants will be divided into two groups: one receiving standard exercises and sham neuromodulation, while the other will receive the same exercises along with active neuromodulation. Both groups will undergo treatment three times a week for four weeks. The aim is to assess whether the addition of neuromodulation can enhance pain relief and improve functional capabilities in these patients.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 25-35 with a diagnosis of fibromyalgia lasting more than six months.
Not a fit: Patients with neurological diseases, severe psychiatric disorders, or unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and quality of life for patients with fibromyalgia.
How similar studies have performed: While there is ongoing research in neuromodulation for pain management, this specific approach in fibromyalgia is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients fibromyalgia from both genders. 2. 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. 3. Their ages will be ranged from 25-35 years old. 4. 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 Criteria: 1. Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease 2. Pacemaker 3. Spinal fusion-cervical or lumbar 4. Metal implants in the spine 5. Pregnancy 6. Epilepsy 7. Severe psychiatric disorder or alcohol and drug abuse. 8. Unstable medical condition which could compromise the participant's welfare or confound the study results. 9. Uncontrolled blood pressure or diabetes 10. Visual or auditory problems. 11. Active inflammatory conditions
Where this trial is running
Sadat, Menoufia
- Al Ryada University for Science and Technology — Sadat, Menoufia, Egypt (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia Syndrome, Fibromyalgia, NEUROMODULATION, Centralization, PAIN BIOMARKERS, FUNCTIONAL OUTCOME