Nerve surgery to treat painful amputation neuromas
Official title: Results of Nerve Surgery to Treat PostAmputation Pain (TreatPAP): a Prospective Study
Run by Leiden University Medical Center · NCT07605754 · Data updated 2026-11-12
This study tests whether nerve-surgery techniques like fascicular split or targeted muscle reinnervation can relieve pain in adults with painful neuromas after an amputation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 98 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Status | Recruiting |
| Started | August 14, 2025 |
| Main results expected | August 20, 2028 |
| Study ends | August 20, 2029 |
| Registry record updated | May 26, 2026 |
| Trial ID | NCT07605754 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with intractable postamputation pain due to painful neuromas who are eligible for surgery and can consent.
✕Probably not a fit
Patients with contraindications to anesthesia or those whose pain persists despite surgical intervention may derive little or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study at Leiden University Medical Center explores surgical approaches for postamputation pain due to neuromas. It focuses on two techniques, fascicular split and targeted muscle reinnervation, to see if they provide pain relief when non-surgical options have failed. Participants are adults with intractable postamputation pain and suitable for anesthesia. Outcomes include pain relief and quality of life following the procedures. The study builds on long-standing experience with neuroma treatment at the Leiden Nerve Center and reports results from real-world clinical practice.
Why it matters
Potential benefit: If successful, participants may experience meaningful reduction in residual and phantom limb pain and improved prosthesis use.
How similar studies have gone: Previous experiences with fascicular split and nerve implantation techniques have reported substantial pain relief in selected patients, supporting potential benefit of these approaches.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age older than or equal to 18 years * Intractable postamputation pain Exclusion Criteria: * Cognitive impairment or delirium at the time of inclusion * Having received previous radiotherapy on the affected limb * Patients who are unable to comprehend the informed consent form or the questionnaires used in the current study * Unfit for general anesthesia
Where it's running
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Leiden University Medical Center
Leiden, South Holland, Netherlands Recruiting
Study contacts
- Principal investigator: Justus L. Groen, MD, PhD — Leiden University Medical Center
- Study coordinator: Guus A.H. Tendijck, MD
- Email: g.tendijck@hotmail.com
- Phone: +316 21320645
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.