Using spinal cord stimulation to treat painful mononeuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Erasmus Medical Centre
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Mathilde Scholtes, MSc
• Email: m.m.a.scholtes@erasmusmc.nl
• Phone: +31650032165

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.