Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Crossover
Treatments tested in this trial
Spinal Cord Stimulator
DeviceThe 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.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: DL-SCS OnlyExperimental treatment 1 intervention
Group B: Stimulation OffPlacebo comparator 1 intervention
Group C: M-SCS OnlyExperimental treatment 1 intervention
Group D: DL-SCS + M-SCSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgerySecondary outcomes
1
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.
Time frame
Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery2
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.
Time frame
Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery3
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.
Time frame
Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery4
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.
Time frame
Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: