NCT Number: NCT04246281
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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Notify Me21 year–75 year
All sexes
Interventional
Not applicable
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Time frame: 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.
Time frame: During the Medial Branch Block procedure
Occurrence and type of study-related AEs
Time frame: During the Lead Placement procedure (SOT)
Occurrence and type of study-related AEs
Time frame: 1-week post-SOT
Occurrence and type of study-related AEs
Time frame: 2-weeks post-SOT
Occurrence and type of study-related AEs
Time frame: 3-weeks post-SOT
Occurrence and type of study-related AEs
Time frame: 4-weeks post-SOT
Occurrence and type of study-related AEs
Time frame: 5-weeks post-SOT
Occurrence and type of study-related AEs
Time frame: 6-weeks post-SOT
Occurrence and type of study-related AEs
Time frame: 7-weeks post-SOT
Occurrence and type of study-related AEs
Time frame: 8-weeks post-SOT
Occurrence and type of study-related AEs
Time frame: 3-months post-SOT
Occurrence and type of study-related AEs
Time frame: 6-months post-SOT
Occurrence and type of study-related AEs
Time frame: 9-months post-SOT
Occurrence and type of study-related AEs
Time frame: 12-months post-SOT
Occurrence and type of study-related AEs
Time frame: 18-months post-SOT
Occurrence and type of study-related AEs
Time frame: 24-months post-SOT
Occurrence and type of study-related AEs
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: Baseline, 3-months after SOT
Analgesic medication consumption will be collected.
SPR Therapeutics, Inc.
Industry
A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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