Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain
- Conditions
- Pain, PostoperativeNeuropathic Pain
- Registration Number
- NCT06390150
- Lead Sponsor
- Nova Scotia Health Authority
- 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
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change from baseline on the Numerical Rating Scale (NRS) for pain intensity 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 Outcome Measures
Name Time Method Change in score on the Brief Pain Inventory Short Form 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.
Change in score on Oswestry Disability Index 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.
Change in score on EuroQol 5 Dimension Questionnaire 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.
Change in score on the 12-item Short Form Survey 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.
Change in morphine equivalents used 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.
Trial Locations
- Locations (1)
Queen Elizabeth Health Science Centre
🇨🇦Halifax, Nova Scotia, Canada
Queen Elizabeth Health Science Centre🇨🇦Halifax, Nova Scotia, Canada