chronic pain Focal pain
Conditions
Interventions
All participants will be implanted with 1 or 2 additional electrodes at the
nerve roots.
Main study cohort:
Subjects from the main study cohort will be randomized twice. First
randomization takes p
Sponsors
Boston Scientific International BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: IC1. Average unilateral foot, knee, or groin pain (of neuropathic origin only) intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit based on 7-day average NRS score IC2. Subject signed a valid, EC-approved informed consent form (ICF) IC3. Willing and able to comply with all protocol-required procedures and assessments/evaluations IC4. At least 80% pain/paresthesia overlap during on-table testing for each set of implanted leads Patients with at least 80% pain/paresthesia overlap at DC/DR leads only will be part of the DC/DR subgroup IC5. If taking prescription opioids for primary chronic pain complaint (low back and/or leg and/or foot and/or knee and/or groin pain), must have been on a stable prescription (same drug(s) and dose(s)) 30 days prior to Screening IC6. Consumed an average total daily morphine equivalent of *100 mg during the 30 days prior to Screening IC7. 18 years of age or older when written informed consent is obtained
Exclusion criteria
Exclusion criteria: EC1. Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study EC2. Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator). EC3. Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study EC4. Currently on any anticoagulant medications that cannot be discontinued during perioperative period EC5. A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception. EC6. Clinically significant lumbosacral stenosis which would interfere with lead placement EC7. Prior history of lumbar-sacral spine fusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There is no primary endpoint. Collected data will be used to increase the understanding of the therapy, guide product development and help define the best practice for programming patients with focal foot, knee, or groin pain using Spinal Cord Stimulation devices. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory endpoints: - Change in average foot, knee, or groin pain and overall pain intensity from Baseline to end of each Period and End of Study (Pain Diary, NRS) - Treatment Satisfaction at end of each Period and End of Study (PSWT) - Global impression of change at end of each Period and End of Study (PGIC) - Change in disability from Baseline to end of each Period and End of Study (ODI) - Change in Quality of life from Baseline to end of each Period and End of Study (EQ-5D-5L) - Change in sleep quality from Baseline to end of each Period and End of Study (PSQI) - Patient preferred program at end of Periods 2 and 4 (Preference Questionnaire) - Physician preferred program at end of Periods 2 and 4 (Preference Questionnaire) - Pain/paresthesia overlap for each tested perception based configuration (Pain/Paresthesia drawings) Safety parameters: - Rate of device and/or procedure related non-serious adverse events - Rate of device and/or procedure related serious adverse events - Rate of unanticipated adverse device effects | — |
Countries
Netherlands
Outcome results
None listed