Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain (MIDL-SCS)

Nova Scotia Health Authority (NSHA)

Status: Not yet enrolling

Conditions: Neuropathic Pain; Pain, Postoperative

Treatments: Device: Spinal Cord Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT06390150

MIDL-SCS

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Diagnosis of neuropathic pain following a surgical procedure
2. A minimum of 50% of pain should be limited to one body part, defined as one limb or one side of trunk.
3. Failed conservative therapies (medication, physiotherapy)
4. Disability more than 6 months

Exclusion criteria

1. Previous implantation with SCS (i.e. revision surgery)
2. Any underlying condition that would preclude an MRI
3. Untreated psychiatric conditions or substance use disorder
4. Existing medical conditions that would preclude from SCS (history of recurrent infections, uncontrolled cancer, etc.)
5. Surgically treatable lesion (e.g. spinal stenosis, disc herniation)
6. Lack of capacity (e.g. significant cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

DL-SCS Only

Experimental group

Description:

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

Treatment:

Device: Spinal Cord Stimulator

Stimulation Off

Placebo Comparator group

Description:

Both electrodes will be programmed for sham stimulation.

Treatment:

Device: Spinal Cord Stimulator

M-SCS Only

Experimental group

Description:

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

Treatment:

Device: Spinal Cord Stimulator

DL-SCS + M-SCS

Experimental group

Description:

Both DL-SCS and M-SCS will be activated with high-frequency, paresthesia free programs.

Treatment:

Device: Spinal Cord Stimulator