Pain, PostoperativeMIDL-SCSNCT06390150
Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain
A study testing Spinal Cord Stimulator in people with Pain, Postoperative and Neuropathic Pain, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Neuropathic Pain
- What is being tested?
- Spinal Cord Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2025to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Queen Elizabeth Health Science Centre
Halifax, Nova Scotia, B3H 3A7
About this study
Official title: 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
Read the 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.
- Conditions
- Pain, Postoperative, Neuropathic Pain
- Being tested
- Spinal Cord Stimulator
- Keywords
- Spinal cord stimulation, Post intra-thoracic surgery pain syndrome
- Medical subject headings
- Pain, Postoperative, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulatorDevice
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 group | Role | What they receive |
|---|---|---|
| DL-SCS Only | Experimental | The DL-SCS electrode will be activated with a high-frequency paresthesia-free program. Receives: Device: Spinal Cord Stimulator |
| Stimulation Off | Placebo comparator | Both electrodes will be programmed for sham stimulation. Receives: Device: Spinal Cord Stimulator |
| M-SCS Only | Experimental | The M-SCS electrode will be activated with a high-frequency, paresthesia free program. Receives: Device: Spinal Cord Stimulator |
| DL-SCS + M-SCS | Experimental | Both DL-SCS and M-SCS will be activated with high-frequency, paresthesia free programs. Receives: Device: Spinal Cord Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study startSep 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lutz Weise, Nova Scotia Health Authority
- Investigators
- Lutz Weise, MD, PhD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390150
- Sponsor's protocol ID
- MIDL-SCS
- Acronym
- MIDL-SCS
- Status last verified
- Jul 2025
- First submitted
- 25 Apr 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain (MIDL-SCS Trial)
- ClinicalTrials.gov ID
- NCT06390150
- Acronym / sponsor ID
- MIDL-SCS / MIDL-SCS
- Conditions
- Pain, Postoperative, Neuropathic Pain
- Keywords
- Spinal cord stimulation, Post intra-thoracic surgery pain syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| DL-SCS Only | Experimental | Device: Spinal Cord StimulatorThe DL-SCS electrode will be activated with a high-frequency paresthesia-free program. |
| Stimulation Off | Placebo comparator | Device: Spinal Cord StimulatorBoth electrodes will be programmed for sham stimulation. |
| M-SCS Only | Experimental | Device: Spinal Cord StimulatorThe M-SCS electrode will be activated with a high-frequency, paresthesia free program. |
| DL-SCS + M-SCS | Experimental | Device: Spinal Cord StimulatorBoth DL-SCS and M-SCS will be activated with high-frequency, paresthesia free programs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord StimulatorThe 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. | Device | DL-SCS + M-SCS, DL-SCS Only, M-SCS Only, Stimulation Off |
Primary outcome
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.
5 secondary outcomes
Change in score on Oswestry Disability Index
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in score on EuroQol 5 Dimension Questionnaire
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in morphine equivalents used
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in score on the Brief Pain Inventory Short Form
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in score on the 12-item Short Form Survey
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lutz Weise, MD, PhD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulator in people with Pain, Postoperative and Neuropathic Pain, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lutz Weise, MD, PhD (902-472-6850, ally.klassen@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.