The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain
- Conditions
- Back PainLow Back Pain
- Interventions
- Device: SPRINT Peripheral Nerve Stimulation (PNS) SystemProcedure: Standard interventional management of low back pain
- Registration Number
- NCT04246281
- Lead Sponsor
- SPR Therapeutics, Inc.
- Brief Summary
The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 230
- Chronic low back pain
Key
- Body Mass Index (BMI) > 40
- Prior lumbar surgery
- Implanted electronic device
- Pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Peripheral Nerve Stimulation (PNS) SPRINT Peripheral Nerve Stimulation (PNS) System Subjects in Group 1 will have leads placed in their lower back. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks. Group 2: Standard Interventional Management (Standard of Care) Standard interventional management of low back pain Subjects in Group 2 will receive the standard of care. Group 2 subjects may be able to crossover to receive PNS after 12 months from start of treatment (Visit 16).
- Primary Outcome Measures
Name Time Method Study-Related Adverse Events (AEs) 24-months post-SOT Occurrence and type of study-related AEs
Reduction in average pain intensity Up to 3-months after Start of Therapy (SOT) Average pain is measured using question 5 from the Brief Pain Inventory- Short Form (BPI-5). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.
- Secondary Outcome Measures
Name Time Method Patient Global Impression of Change 3-months after SOT Measured using the Patient Global Impression of Change (PGIC) survey. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved" relative to baseline.
Reduction in pain interference Baseline, 3-months after SOT Measured using question 9 from the Brief Pain Inventory- Short Form. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week.
Reduction in disability Baseline, 3-months after SOT Measured using the Oswestry Disability Index (ODI). The ODI asks subjects to rate how their back pain impacts ten components of everyday life. For each section, the answers correlate to a scale which ranges from 0 to 5, where 0 is no disability and 5 is maximum disability.
Durability of reductions in pain intensity Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT Measured using question 5 from the Brief Pain Inventory- Short Form (BPI-5). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.
Reduction in worst pain intensity Baseline, 3-months after SOT Measured using question 3 from the Brief Pain Inventory- Short Form (BPI-3). BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.
Change in health-related quality of life Baseline, 3-months after SOT Measured using the EQ-5D survey. The EQ-5D is a five-level scale. Each level is coded from 1 to 5, where 1 indicates no problems and 5 indicates extreme problems. The EQ-5D also includes a 0 to 100 scale for health status, where 0 indicates "the worst health you can imagine" and 100 indicates "the best health you can imagine".
Change in analgesic medication usage Baseline, 3-months after SOT Analgesic medication consumption will be collected.
Trial Locations
- Locations (18)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
IPM Medical Group
🇺🇸Walnut Creek, California, United States
International Spine, Pain & Performance Center
🇺🇸Washington, District of Columbia, United States
Millennium Pain Center
🇺🇸Bloomington, Illinois, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Premier Pain Centers
🇺🇸Shrewsbury, New Jersey, United States
Duke University
🇺🇸Durham, North Carolina, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Main Line Spine
🇺🇸King Of Prussia, Pennsylvania, United States
Spine and Nerve Center of St. Francis Hospital
🇺🇸Charleston, West Virginia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Institute of Precision Pain Medicine
🇺🇸Corpus Christi, Texas, United States
Denver Back Pain Specialists
🇺🇸Greenwood Village, Colorado, United States
Northwest Speciality Hospital
🇺🇸Post Falls, Idaho, United States
Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Virginia iSpine Physicians
🇺🇸Richmond, Virginia, United States
Hunter Holmes McGuire Veterans Affairs Medical Center
🇺🇸Richmond, Virginia, United States