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

Sponsor
Nova Scotia Health Authority
Study ID
NCT06390150
Status
Not Yet Recruiting

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Conditions

  • Neuropathic Pain
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

First listed
Apr 30, 2024
Start date
Sep 30, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2028
Completion
Jul 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: DL-SCS Only
    The DL-SCS electrode will be activated with a high-frequency paresthesia-free program.
  • Placebo Comparator: Stimulation Off
    Both electrodes will be programmed for sham stimulation.
  • Experimental: M-SCS Only
    The M-SCS electrode will be activated with a high-frequency, paresthesia free program.
  • Experimental: DL-SCS + M-SCS
    Both DL-SCS and M-SCS will be activated with high-frequency, paresthesia free programs.

Primary Outcome Measure

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 ]

Central Contacts

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