N/A
N=20
Repetitive Transcranial Magnetic Stimulation (rTMS) in Fibromyalgia
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT03909009 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Visual Analog Scale-Pain — 5.30; 6.80 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rTMS + Neuronavigation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Izmir Katip Celebi University
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale-Pain |
5.70; 6.70 | — |
| SECONDARY Visual Analog Scale-Pain |
5.70; 6.70 | — |
| SECONDARY Fibromyalgia Impact Questionnaire |
48.35; 54.39 | — |
Summary
This study aims to evaluate the effectiveness of 10 Hz neuronavigated repetitive transcranial magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex (DLPFC) on pain, stiffness, fatigue, depression/anxiety, quality of life and cognitive functions in fibromyalgia syndrome (FMS).
Eligibility Criteria
Inclusion Criteria
- Adults (age between 18-65 years)
- Diagnosis of fibromyalgia syndrome according to 2016 Fibromyalgia diagnostic criteria
- The mean pain intensity is VAS ≥ 4/10
- Stable treatment for at least last 3 months
- Patients accepting participation by signing an informed consent form
Exclusion Criteria
- To have a clinical condition to be contraindicated for TMS (metallic implant, cardiac pace, pregnancy, lactation, epilepsy, head trauma, history of cranial operation...)
- The presence of malignancy
- Systemic rheumatic diseases
- Major orthopedic / neurological problems that limit daily life activities
- Alcohol or drug addiction
- Major depression / personality disorder history
- Have received TMS treatment before
- Pregnancy or breastfeeding
Data sourced from ClinicalTrials.gov (NCT03909009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.