N/A
N=12
Intraoperative Neuromonitoring Recording With a Novel SCS Paddle
Chronic Pain · Neuropathic Pain · Failed Back Surgery Syndrome · Complex Regional Pain Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT05045625 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Numeric Rating Scale (NRS) — 5.333333333 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HD Study Electrode (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albany Medical College
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale (NRS) |
5.333333333 | — |
| SECONDARY McGill Pain Questionnaire (MPQ) |
8.222222222 | — |
| SECONDARY Oswestry Disability Index (ODI) |
50 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
18 | — |
| SECONDARY Beck Depression Index (BDI) |
14.33333333 | — |
Summary
The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.
Eligibility Criteria
Inclusion Criteria
- patients undergoing a spinal cord stimulation procedure for neuropathic pain
- must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.
- subjects must be able to give informed consent.
Exclusion Criteria
- patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain
Data sourced from ClinicalTrials.gov (NCT05045625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.