Neuromodulation therapy for fibromyalgia pain relief
Effect Of Neuromodulation on Pain and Quality of Life In Patient With Fibromyalgia Syndrome
This study is testing if a special electric therapy can help women aged 20-45 with fibromyalgia feel less pain and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT06799091 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of transcutaneous electric nerve stimulation (TENS) in alleviating symptoms of fibromyalgia syndrome (FMS) in female patients aged 20-45. Forty participants are randomly divided into two groups: one receiving low-frequency TENS therapy and the other receiving placebo treatment alongside physiotherapy. The study measures pain levels, anxiety, and quality of life through cortisol levels and standardized questionnaires over six weeks of treatment. The aim is to provide preliminary evidence on the benefits of neuromodulation for managing fibromyalgia symptoms.
Who should consider this trial
Good fit: Ideal candidates are women aged 20-45 diagnosed with fibromyalgia according to established criteria.
Not a fit: Patients with other autoimmune disorders or those on strong pain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce pain and improve quality of life for fibromyalgia patients.
How similar studies have performed: While neuromodulation approaches have been explored, this specific application of TENS in fibromyalgia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: women between 20-45 years old, (ii) diagnoses according to the 2016 American College of Rheumatology criteria for fibromyalgia \[1\] \- Symptoms have been present at a similar level for at least three months (iii) Absence of other disorders that causes similar symptoms: systemic lupus erethromatosis (SLE), rheumatoid arthritis (RA) and Lyme disease based on laboratory investigations (erythrocyte sedimentation rate (ESR), Anti anti-cyclic citrullinated peptide (Anti CCP), antinuclear antibody (ANA) and Rheumatoid factor (RF)). Exclusion Criteria: * any medical, neurological, or psychiatric illness, use of strong opioids or other painkillers except paracetamol and/or ibuprofen, benzodiazepine, illicit drug or alcohol use, recent use of cannabis, pregnancy, breast feeding, and the presence of pain syndromes other than FM. Presence of other autoimmune disorders e.g.: rheumatoid arthritis and systemic lupus erethromatosus
Where this trial is running
Giza
- Faculty of physical therapy laps at cairo university — Giza, Egypt (Recruiting)
Study contacts
- Study coordinator: Rowida Abd Elgleel, Lecturer
- Email: rowidaabdelglel@cu.edu.eg
- Phone: 01152322678
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.