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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-PR170708 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Peripheral Nerve Stimulation (PNS) | Active Comparator | 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. |
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| Group 2: Standard Interventional Management (Standard of Care) | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPRINT Peripheral Nerve Stimulation (PNS) System | Device | The SPRINT System delivers mild electrical stimulation to the nerves in your low back. The SPRINT System includes up to two leads (small wires) that are placed through your skin into your low back. The leads attach to devices worn on your body that deliver stimulation (called Stimulators). |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in average pain intensity | 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. | Up to 3-months after Start of Therapy (SOT) |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | During the Medial Branch Block procedure |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | During the Lead Placement procedure (SOT) |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 1-week post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 2-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 3-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 4-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in pain interference | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| IPM Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42290901 | Derived | Li S, McCormick ZL, Lester DD, DePalma MJ, Gilmore CA, Jameson JB, Desai MJ, Weaver TE, Lad SP, Davidoff SJ, Trainor DM, Amirdelfan K, Engle MP, Deer TR, Lee TS, Vetri F, Bindal M, Tornero-Bold MA, Nasseri MN, Cohen SP, Clark WH, McGee MJ, Boggs JW. Observations from the RESET clinical trial: A post-hoc per protocol analysis of clinical outcomes with percutaneous 60-day medial branch PNS in chronic low back pain. Interv Pain Med. 2026 Jun 6;5(2):100775. doi: 10.1016/j.inpm.2026.100775. eCollection 2026 Jun. |
| Label | URL |
|---|---|
| Sponsor's Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2024 | Oct 28, 2025 |
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| Standard interventional management of low back pain | Procedure | Your doctor will determine which procedure or intervention is appropriate for your back pain. You may receive radiofrequency ablation, spinal cord stimulation, surgery, or another procedure or treatment, as appropriate. |
|
| 5-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 6-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 7-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 8-weeks post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 3-months post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 6-months post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 9-months post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 12-months post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 18-months post-SOT |
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 24-months post-SOT |
| Baseline, 3-months after SOT |
| Reduction in disability | 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. | Baseline, 3-months after SOT |
| Durability of reductions in pain intensity | 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. | Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT |
| Reduction in worst pain intensity | 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. | Baseline, 3-months after SOT |
| Patient Global Impression of Change | 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. | 3-months after SOT |
| Change in health-related quality of life | 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". | Baseline, 3-months after SOT |
| Change in analgesic medication usage | Analgesic medication consumption will be collected. | Baseline, 3-months after SOT |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Denver Back Pain Specialists | Greenwood Village | Colorado | 80111 | United States |
| International Spine, Pain & Performance Center | Washington D.C. | District of Columbia | 20006 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Northwest Speciality Hospital | Post Falls | Idaho | 83854 | United States |
| Millennium Pain Center | Bloomington | Illinois | 61704 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Premier Pain Centers | Shrewsbury | New Jersey | 07702 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Main Line Spine | King of Prussia | Pennsylvania | 19406 | United States |
| Institute of Precision Pain Medicine | Corpus Christi | Texas | 78414 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| Virginia iSpine Physicians | Richmond | Virginia | 23235 | United States |
| Hunter Holmes McGuire Veterans Affairs Medical Center | Richmond | Virginia | 23249 | United States |
| Spine and Nerve Center of St. Francis Hospital | Charleston | West Virginia | 25301 | United States |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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