Gait Improvement With Spinal Cord Stimulation in Postoperative Back Pain Patients

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

In this pilot study, eligible adults with chronic lumbar radiculopathy and failed back surgery syndrome undergo a two-stage spinal cord stimulation procedure. First, an electrode is implanted and tested externally for about a week; if pain improves by at least 50%, a second internal stimulator is connected to deliver different modes (tonic, microburst, high frequency) to see which helps most. Over three months, patients experience different stimulation settings in random order, with walking and pain assessments repeated to identify the most beneficial modality. Walking is quantified with objective measures, and questionnaires evaluate pain, function, and quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 18 year old and \< or = 70 year old
* Patients with chronic neuropathic lumbo-sciatalgia (DN4 score \> or = 4/10) as part of a moderate to severe spinal surgery failure syndrome (EVA \>50/100), in who a collegial and multidisciplinary indication of medullary stimulation treatment was chosen.
* Patients awith Social Security

Exclusion Criteria:

* Vulnerable persons
* Patients who are invalid and unable to perform a quantified walk analysis
* Contraindication to surgery or anesthesia
* Patient not able to complete questionnaires
* Woman of childbearing age without effective contraception

Where it's running

• Chu de Nice
  Nice, France Recruiting

Study contacts

• Study coordinator: LE GOFF Ludovic, MD
• Email: legoff.l@chu-nice.fr
• Phone: +334 92 03 55 07

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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.