Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2030-07-31

Brief Summary

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The goal of this interventional study is to learn if dorsolateral spinal cord stimulation (DL-SCS) can treat focal post-surgical, medically refractory neuropathic pain. The main question it aims to answer is:

\- How does DL-SCS compare to traditional SCS and no treatment for treating post-surgical neuropathic pain?

Participants will be asked to

* trial combinations of stimulation across blocks of weeks (randomized cross-over)
* rate their pain after each stimulation trial

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Detailed Description

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Neuropathic pain resulting from injury to the somatosensory nervous system can be a persistent and debilitating condition of spontaneous and unprovoked symptoms. For patients with chronic neuropathic pain that does not respond to conservative therapy, spinal cord stimulation (SCS) may be considered. SCS has been established as an effective and sustained treatment for neuropathic pain, but may deliver treatment to more than just the pain area. Dorsolateral spinal cord stimulation (DL-SCS) may provide a more focal alternate target for spinal stimulation. The aim of this study is to investigate DL-SCS as a therapeutic option for post-surgical, medically refractory neuropathic pain. This is a prospective, randomized, double-blind controlled crossover trial to investigate the efficacy of DL-SCS and midline SCS (M-SCS) compared to sham stimulation for the diagnosis of post-surgical neuropathic pain. Each participant will be implanted with two electrodes and will crossover into each stimulation program in a randomized order to serve as their own control.

Conditions

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Pain, Postoperative Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study will be conducted as a placebo-controlled, crossover, randomized clinical trial of the intervention dorsolateral spinal cord stimulation (DL-SCS) for the indication post-surgical focal neuropathic pain. Study arm order will be randomly generated and known only to the programmer. Once participants have crossed over into all study arms, they will be set on their best program and enter long-term observation.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DL-SCS Only

The DL-SCS electrode will be activated with a high-frequency paresthesia-free program.

Group Type EXPERIMENTAL