Chronic Pain, Intractable Pain
Conditions
Brief summary
The PERSIST study is being conducted within Medtronic's active post-market surveillance platform, the Product Surveillance Registry (PSR). The purpose of PERSIST is to generate long-term evidence for the Inceptiv™ Spinal Cord Stimulation therapy.
Interventions
DEVICECommercially available Inceptiv™ neurostimulation systems
Spinal cord stimulation therapy delivered during trialing and following implant of commercially available Inceptiv™ neurostimulation systems
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Patient must be SCS therapy naïve 3. A clinical decision was made for the patient to receive an Inceptiv™ SCS system (pending satisfactory results from a Medtronic SCS trial) limited to on-label leads based on the specific geography for an on-label indication prior to enrollment in the study. 4. Patient is on stable opioid dosage for 3 months prior to enrollment, if applicable 5. Pain intensity of ≥ 6 as measured using the NPRS (0-10) in the predominant area(s) of pain that SCS is intended to treat 6. Patient must have an on-label indication specific to geography. * NOTE: Patients may be enrolled if they have upper limb radicular limb pain, related or unrelated to spine surgery * NOTE: In the US, patients experiencing chronic back pain without a history of spine surgery and not eligible for spine surgery are on-label candidates for SCS if the pain is associated with degenerative disc disease, herniated disc, or radicular pain syndrome. Radicular pain syndrome (with or without prior spine surgery) is an approved indication for SCS implant. 7. Diagnosis of chronic back and/or limb pain for an on-label indication lasting at least six months.
Exclusion criteria
1. Has any existing or is planning to have a new active implantable neuromodulation device or system during the 5 year follow up period (e.g., peripheral nerve stimulation, sacral neuromodulation, intrathecal drug delivery system, a second SCS system) 2. Has a complex pain pattern that involves both upper and lower limbs or back and upper limb 3. Has a planned major medical procedure within 6 months before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator 4. Has a planned interventional procedure within 6 weeks (+/- 2 weeks) before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator 5. Major untreated or unstable psychiatric comorbidity, such as suicidal ideations, personality disorders, schizophrenia etc., that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study, as determined by the Investigator 6. Subjects with PCS total score \>30 are not eligible unless ALL of the following are met: 1. Absence of uncontrolled major psychiatric disorder or active suicidality based on clinical evaluation. 2. Investigator documentation of adequate understanding of therapy, realistic expectations, and anticipated compliance with protocol follow-up 7. Major non-indicated, untreated or refractory progressive disease (e.g., neurodegenerative disease {not including Diabetic Peripheral Neuropathy}, heart failure, cancer, osteoarthritis, fibromyalgia, chronic fatigue syndrome), or injury (e.g., fall resulting in hip fracture) that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study as determined by the Investigator 8. Has inpatient or outpatient admissions for drug or alcohol dependency within past 12 months or current/ongoing substance abuse 9. Has a current prescription of ≥90 morphine milligram equivalents (MME) per day 10. Has predominant mechanical back pain arising from facet or sacroiliac joint pain as the main cause of chronic low-back pain if low-back pain is the predominant pain condition, as determined by the Investigator 11. Has mechanical spine instability (eg. Spondylolisthesis grade 2) as determined by the Investigator 12. Has an active systemic or local infection that would delay trial or implant 13. Is pregnant or planning on becoming pregnant 14. Has a life expectancy of less than 1 year 15. Involved in an injury claim, under current litigation, beneficiary of an injury claim, receiving worker's compensation, or planning any future litigation 16. Has a condition that the Investigator determines would significantly increase perioperative risk (e.g., unstable or severe cardiac disease, liver disease, uncontrolled diabetes, kidney disease) Patients enrolled into the study with Diabetic Peripheral Neuropathy, Complex Regional Pain Syndrome and Upper Limb pain are required to meet further inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of implanted patients who have a ≥ 50% improvement in pain score as assessed by numeric pain rating scale (NPRS) from baseline for the predominant pain being treated at 6 months following device activation | Baseline and 6 months after device activation | This outcome measures the percentage of implanted patients who demonstrate improvement in pain for the predominant pain condition being treated at 6 months following device activation, compared to baseline. Pain is assessed using the NPRS (with 0=no pain and 10=highest level of pain). |
| Percentage of implanted patients who are a composite responder at 6 months following device activation | Baseline and 6 months after device activation | A composite responder is defined as an implanted patient who demonstrates an improvement from baseline in at least one of the following measures at the specified follow-up time: pain, quality of life, or pain-related disability. Pain is assessed using the Numeric Pain Rating Scale (NPRS 0=no pain and 10=worst possible pain), with improvement defined as a reduction in pain score from baseline. Quality of life is assessed using the EQ-5D-5L index value, with improvement defined as positive change from baseline. Pain-related disability is assessed using the Pain Disability Index (PDI), with improvement defined as negative change from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of implanted patients who are a composite responder | Baseline and 3 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months after device activation | A composite responder is defined as an implanted patient who demonstrates an improvement from baseline in at least one of the following measures at the specified follow-up time: pain, quality of life, or pain-related disability. Pain is assessed using the Numeric Pain Rating Scale (NPRS 0=no pain and 10=worst possible pain), with improvement defined as a reduction in pain score from baseline. Quality of life is assessed using the EQ-5D-5L index value, with improvement defined as positive change from baseline. Pain-related disability is assessed using the Pain Disability Index (PDI), with improvement defined as negative change from baseline. |
Countries
France, United States
Contacts
CONTACTStudy Inbox
STUDY_DIRECTORHolly Norman, PhD, MBA
Medtronic
Outcome results
None listed