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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Neuropathic Pain
• Intervention / Treatment: Device: Spinal Cord Stimulator

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lutz Weise, MD, PhD; Phone Number: 902-472-6850; Email: ally.klassen@nshealth.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth Health Science Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DL-SCS Only; The DL-SCS electrode will be activated with a high-frequency paresthesia-free program.	Device: Spinal Cord Stimulator; 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.
Placebo Comparator: Stimulation Off; Both electrodes will be programmed for sham stimulation.	Device: Spinal Cord Stimulator; 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.
Experimental: M-SCS Only; The M-SCS electrode will be activated with a high-frequency, paresthesia free program.	Device: Spinal Cord Stimulator; 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.
Experimental: DL-SCS + M-SCS; Both DL-SCS and M-SCS will be activated with high-frequency, paresthesia free programs.	Device: Spinal Cord Stimulator; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score on Oswestry Disability Index	Assesses a patient's quality of life in relation to back pain on a 10-section questionnaire. A low score indicates no disability and a high score indicates severe disability.	Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in score on EuroQol 5 Dimension Questionnaire	Assesses overall quality of life in five dimensions including mobility, self-care, daily routine, pain, and anxiety/depression. A low score indicates poor health and a high score indicates excellent health.	Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in morphine equivalents used	Measures patient pain by assessing the amount of pain medication taken by a patient. Higher usage indicates a greater level of pain and a lower usage indicates a lower level of pain.	Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in score on the Brief Pain Inventory Short Form	Assesses the impact of pain on a patient's quality of life. A high score indicates a severe impact and a lower score indicates minimal impact.	Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in score on the 12-item Short Form Survey	Assesses how a patient's health impacts their quality of life. A higher score indicates a better quality of life, and a low score indicates a poorer quality of life.	Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Lutz Weise, MD, PhD, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Spinal cord stimulation; Post intra-thoracic surgery pain syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain, Postoperative; Neuralgia
• Other Study ID Numbers: MIDL-SCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No