Pain neuroscience education for fibromyalgia patients
Effects and Mechanisms of Pain Neuroscience Education on Pain Severity, Disease Severity, Pain Catastrophizing, and Cognitive Function in Patients With Fibromyalgia : A Randomized Controlled Trial
This study is testing if a nurse-led education program about pain can help people with fibromyalgia feel better compared to a self-management group.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Taipei Medical University Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06097091 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effectiveness of a nurse-led pain neuroscience education (PNE) program compared to a self-management education group in patients with fibromyalgia. The study will assess pain intensity, fibromyalgia severity, pain catastrophizing, and cognitive performance using various validated scales. Additionally, it aims to explore the brain changes associated with PNE through quantitative electroencephalography (QEEG). Participants will be monitored at three time points: baseline, immediately after the intervention, and three months post-intervention.
Who should consider this trial
Good fit: Ideal candidates are Chinese-speaking individuals diagnosed with fibromyalgia who meet specific severity criteria.
Not a fit: Patients with a history of traumatic brain injury, neurological disorders, current psychopathological disorders, cancer, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve pain management and cognitive function in fibromyalgia patients.
How similar studies have performed: This approach is novel as it is the first RCT to examine a Chinese-language PNE program and its effects on brain circuitry in fibromyalgia patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must read and understand Chinese language. * According to the 2016 ACR diagnostic criteria, participants' PDS scores more than or equal to 13 points Exclusion Criteria: * Subjects who have medical history of traumatic brain injury or neurological disorder. * Subjects who have present psychopathologic disorder. * Subjects who are cancer. * Subjects who are pregnancy.
Where this trial is running
Taipei
- Bio-Behavior Research Laboratory — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Pei-Shan Tsai, PhD
- Email: ptsai@tmu.edu.tw
- Phone: +88627361661
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.