SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1: Peripheral Nerve Stimulation (PNS) 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. |
Device: SPRINT Peripheral Nerve Stimulation (PNS) System
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).
|
| Active Comparator: Group 2: Standard Interventional Management (Standard of Care) 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). |
Procedure: Standard interventional management of low back pain
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.
|
Outcome Measures
Primary Outcome Measures
- Reduction in average pain intensity and/or reduction in disability [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. Disability is 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.
- Study-Related Adverse Events (AEs) [During the Medial Branch Block procedure]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [During the Lead Placement procedure (SOT)]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [1-week post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [2-weeks post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [3-weeks post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [4-weeks post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [5-weeks post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [6-weeks post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [7-weeks post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [8-weeks post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [3-months post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [6-months post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [9-months post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [12-months post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [18-months post-SOT]
Occurrence and type of study-related AEs
- Study-Related Adverse Events (AEs) [24-months post-SOT]
Occurrence and type of study-related AEs
Secondary Outcome Measures
- Reduction in average pain intensity [Baseline, 3-months after SOT]
Measured using question 5 from the Brief Pain Inventory- Short Form. BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
- Chronic low back pain
Key Exclusion Criteria:
-
Body Mass Index (BMI) > 40
-
Prior lumbar surgery
-
Implanted electronic device
-
Pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 2 | IPM Medical Group | Walnut Creek | California | United States | 94598 |
| 3 | Denver Back Pain Specialists | Greenwood Village | Colorado | United States | 80111 |
| 4 | International Spine, Pain & Performance Center | Washington | District of Columbia | United States | 20006 |
| 5 | Millennium Pain Center | Bloomington | Illinois | United States | 61704 |
| 6 | Forest Health Medical Center | Ypsilanti | Michigan | United States | 48198 |
| 7 | Premier Pain Centers | Shrewsbury | New Jersey | United States | 07702 |
| 8 | Duke University | Durham | North Carolina | United States | 27710 |
| 9 | Center for Clinical Research | Winston-Salem | North Carolina | United States | 27103 |
| 10 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 11 | Carolinas Center for Advanced Management of Pain | Greenville | South Carolina | United States | 29615 |
| 12 | Institute of Precision Pain Medicine | Corpus Christi | Texas | United States | 78414 |
| 13 | University of Utah | Salt Lake City | Utah | United States | 84108 |
| 14 | Virginia iSpine Physicians | Richmond | Virginia | United States | 23235 |
| 15 | Hunter Holmes McGuire Veterans Affairs Medical Center | Richmond | Virginia | United States | 23249 |
| 16 | Spine and Nerve Center of St. Francis Hospital | Charleston | West Virginia | United States | 25301 |
Sponsors and Collaborators
- SPR Therapeutics, Inc.
- United States Department of Defense
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 0151-CSP-000
- CDMRP-PR170708