The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain

Study Overview
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Brief Summary
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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)

Official Title
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A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain

Conditions
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Low Back Pain, Back Pain

Intervention / Treatment
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* Device: SPRINT Peripheral Nerve Stimulation (PNS) System
* Procedure: Standard interventional management of low back pain


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Chronic low back pain Key Exclusion Criteria: Body Mass Index (BMI) > 40 Prior lumbar surgery Implanted electronic device Pregnant

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Peripheral Nerve Stimulation (PNS)<br>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<br>* 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).<br>|
| Active Comparator: Group 2: Standard Interventional Management (Standard of Care)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Stimulation, Neuromodulation