Using spinal cord stimulation to treat painful mononeuropathy
Spinal Cord Stimulation for Intractable Mononeuropathy: a Pilot Study
This study is testing whether spinal cord stimulation can help people with painful nerve issues who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06546371 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to explore the effectiveness of spinal cord stimulation (SCS) in patients suffering from painful intractable peripheral mononeuropathy, particularly those who have not responded to conventional treatments. The study will involve 12 patients and will assess the effects of SCS based on established pain measurement guidelines. The findings will help estimate the effect size and inform the design of a larger randomized controlled trial in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with painful intractable peripheral mononeuropathy in the distal extremities that has not responded to conventional treatments for at least six months.
Not a fit: Patients with mononeuropathy located in the head or torso, or those with a life expectancy of less than one year, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant pain relief for patients with resistant mononeuropathy.
How similar studies have performed: Previous studies have indicated that spinal cord stimulation can be effective for similar conditions, but this specific approach is exploratory and aims to gather preliminary data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suffering from painful intractable peripheral mononeuropathy in the distal extremities, preferably post-traumatic or post-surgical, confirmed by electromyography (EMG) * Symptoms refractory to conventional medical management for at least 6 months according to treating physician * 18 years or older * Pain score on numeric rating scale (NRS) of at least 5 (average pain intensity in week prior to assessment) * Stable or absent concomitant analgesics Exclusion Criteria: * Mononeuropathy located in the head or torso * Mononeuropathy by avulsion at the plexus brachialis * Life expectancy \<1 year * Anticoagulant drug therapy or disturbed coagulation * Immune-compromised patients * Pregnancy * Lack of cooperation of the patient or patient has a history of noncompliance with regard to (a) medical regime(s) * Patients with psychological factors or addiction that require treatment
Where this trial is running
Rotterdam, South Holland
- Erasmus Medical Centre — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Mathilde Scholtes, MSc
- Email: m.m.a.scholtes@erasmusmc.nl
- Phone: +31650032165
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.