Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · May 4, 2023

Keywords

ClinConnect Summary

This clinical trial, called GaitStim, is exploring how spinal stimulation can improve walking in patients who have not found relief from their back pain after surgery, a condition known as Failed Back Surgery Syndrome. The study aims to see if this treatment can help patients walk better compared to their condition before the stimulation.

To be eligible for the trial, participants need to be between 18 and 70 years old and have chronic pain in their lower back and legs, which hasn’t improved with previous surgeries. They also need to have coverage from Social Security. Participants will undergo an evaluation to see how much their walking improves with the spinal stimulation treatment. It’s important to note that the trial is not yet recruiting participants, so people interested will need to wait until it starts. Additionally, certain individuals, such as those who cannot walk or have specific health issues that prevent surgery, will not be able to participate.

Gender

ALL

Eligibility criteria

• 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