An interventional study of SPRINT Peripheral Nerve Stimulation (PNS) System and Standard interventional management of low back pain in Low Back Pain and Back Pain, sponsored by SPR Therapeutics, Inc.. Completed at 18 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by SPR Therapeutics, Inc. · Not applicable, Interventional, and Treatment
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)
2,817 studies on the registry are indexed under Low Back Pain; 481 are open to participants now.
This study's enrollment of 230 is above the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →SPR Therapeutics, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Key Inclusion Criteria:
Key Exclusion Criteria:
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
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
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).
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.
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.
Time frame: Up to 3-months after Start of Therapy (SOT)
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: During the Medial Branch Block procedure
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: During the Lead Placement procedure (SOT)
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 1-week post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 2-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 3-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 4-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 5-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 6-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 7-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 8-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 3-months post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 6-months post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 9-months post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 12-months post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 18-months post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Time frame: 24-months post-SOT
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: Baseline, 3-months after SOT
Change in analgesic medication usage
Analgesic medication consumption will be collected.
Time frame: Baseline, 3-months after SOT
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SPR Therapeutics, Inc.