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NCT Number: NCT06390150

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Health Science Centre

Halifax, Nova Scotia, B3H 3A7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Change in score on Oswestry Disability Index

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

    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.

  2. Change in score on EuroQol 5 Dimension Questionnaire

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

    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.

  3. Change in morphine equivalents used

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

    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.

  4. Change in score on the Brief Pain Inventory Short Form

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

    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.

  5. Change in score on the 12-item Short Form Survey

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lutz Weise, MD, PhD

CONTACT

[email protected]

902-472-6850

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Acronym: MIDL-SCS

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Apr 30, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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