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

NCT06390150 | Not Yet Recruiting

• 1 other identifier: MIDL-SCS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative; Neuropathic Pain

Keywords

Spinal cord stimulation; Post intra-thoracic surgery pain syndrome

Outcome Measures

Primary Outcomes (1)

• Change from baseline on the Numerical Rating Scale (NRS) for pain intensity

  The primary outcome is the self-reported difference in change from baseline of the severity of pain quantified in the Numerical Rating Scale. This will be assessed at baseline (pre-surgery) and at regular follow-up appointments.

  Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery

Secondary Outcomes (5)

• Change in score on Oswestry Disability Index

  Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery

• Change in score on EuroQol 5 Dimension Questionnaire

  Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery

• Change in morphine equivalents used

  Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery

• Change in score on the Brief Pain Inventory Short Form

  Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery

• Change in score on the 12-item Short Form Survey

  Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery

Study Arms (4)

DL-SCS Only

EXPERIMENTAL

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

Device: Spinal Cord Stimulator

Stimulation Off

PLACEBO COMPARATOR

Both electrodes will be programmed for sham stimulation.

Device: Spinal Cord Stimulator

M-SCS Only

EXPERIMENTAL

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

Device: Spinal Cord Stimulator

DL-SCS + M-SCS

EXPERIMENTAL

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

Device: Spinal Cord Stimulator

Interventions

Spinal Cord Stimulator DEVICE

The spinal cord stimulator is an implantable pulse generator connected to electrodes with leads that stimulate the spinal cord. The device is programmed to deliver therapeutic stimulation to treat pain.

DL-SCS + M-SCS; DL-SCS Only; M-SCS Only; Stimulation Off

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth Health Science Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Neuralgia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Lutz Weise, MD, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lutz Weise, MD, PhD

CONTACT

902-472-6850; ally.klassen@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)