Rehabilitation for chronic pain in small fiber neuropathy patients
Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy
This study is testing a rehabilitation program that combines pain education, therapy, and activity to help people with small fiber neuropathy manage their chronic pain and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Ziekenhuis Maastricht Academic / other |
| Locations | 2 sites (Maastricht, Limburg and 1 other locations) |
| Trial ID | NCT05798949 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with small fiber neuropathy (SFN), a condition characterized by severe neuropathic pain and autonomic dysfunction. It aims to implement a rehabilitation program that includes pain education, cognitive behavioral therapy, and graded activity to address both the physical and psychological aspects of chronic pain. The approach is based on the understanding that psychological factors, such as fear and catastrophizing, can exacerbate pain and disability. By utilizing a biopsychosocial model, the study seeks to improve the quality of life for individuals suffering from SFN.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with skin-biopsy proven idiopathic small fiber neuropathy.
Not a fit: Patients with underlying conditions causing small fiber neuropathy or those who have received cognitive behavioral therapy in the last 6 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this rehabilitation program could significantly reduce pain and improve the quality of life for patients with small fiber neuropathy.
How similar studies have performed: Previous studies have shown that biopsychosocial approaches can effectively reduce disability and improve quality of life in chronic pain conditions, suggesting potential success for this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged older than 18 years, * Skin-biopsy proven idiopathic small fiber neuropathy (SFN), * Main goal/purpose to achieve with rehabilitation therapy. Exclusion Criteria: * Are not able to provide written informed consent, * Have an underlying condition of SFN (diabetes, SCN (sodium voltage-gated channel alpha) 9A (subunit 9A) /10A (subunit 10A) /11A (subunit 11A) mutation, hypothyroidism, renal failure, vitamin B12 deficiency, monoclonal gammopathy of undetermined significance, alcohol abuses, malignancies, chemotherapeutic drugs), * Have other neurological disease than SFN that may cause pain in the feet and/or damage to the somatosensory nervous system, are excluded, * Have received any form of cognitive behavioral therapy within the last 6 months will be excluded from this study, * Have insufficient comprehension of the Dutch language.
Where this trial is running
Maastricht, Limburg and 1 other locations
- Adelante Zorggroep — Maastricht, Limburg, Netherlands (Recruiting)
- Maastricht University Medical Center — Maastricht, Netherlands (Recruiting)
Study contacts
- Principal investigator: J. AC Verbunt, MD, PhD — Adelante Zorggroep
- Study coordinator: A. Damci, MD
- Email: aysun.damci@mumc.nl
- Phone: 0031433876584
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.