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The Use of Rechargeable Spinal Cord Stimulators for the Treatment of Neuropathic Pain

NCT05373654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-29

No results posted yet for this study

Summary

Neuropathic pain occurs due to one or several lesions of the central or peripheral nervous system.

Spinal cord stimulation is now recommended in France by the Haute Autorité de Santé (HAS) to relieve chronic refractory neuropathic pain (HAS 2014) in the trunk, upper and lower limbs.

Spinal cord stimulation can be done either through a standard spinal cord stimulator or with a rechargeable spinal cord stimulator.

In this study, the investigators aim at assessing the recharge procedure and their constraints for consecutive patients operated for spinal cord stimulation with a rechargeable stimulator for the treatment of chronic neuropathic pain at the site by the same surgeon between 2019 and 2020.

Conditions

  • Neuropathic Pain

Interventions

OTHER

F-SUS Questionnaire

This F-SUS questionnaire uses a Likert scale including 5 possible responses ranging from " I do not agree at all" to " I completely agree " (Celenza A 2011, Croasmun JT 2011). The F-SUS is a short questionnaire with 10 questions (Brooke J 2013). In its original version half of the questions express strong agreement and the other half disagreement. Thus, all the even-numbered items (2, 4, 6, 8, 10) allow the participant to express a very negative opinion (disagreement). On the other hand, the odd-numbered items allow the participant to express a very positive opinion (strong agreement).

OTHER

Interview (only for dissatisfied patients)

Patients that are dissatisfied with the recharge procedure (Score F-SUS \< 70/100) will be invited to a so-called complementary information interview (an interview after the questionnaire has been completed). The corpus (the study group that will be interviewed) will naturally be diverse men/women, patients who were improved or not by stimulation, implanted with a rechargeable stimulator directly/replacing a stimulator, different brands of stimulator… The patient must agree to the interview and the way it will be performed (signature of consent form). The interview may be face-to -face at the site or by remote videoconference depending on the wishes and availability of the patient. There is no payment for these interviews but travelling or videoconference expenses are reimbursed All interviews will be audio- taped for further qualitative analysis.

Sponsors & Collaborators

  • Elsan

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-04-17
Completion
2023-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373654 on ClinicalTrials.gov