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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04246281
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : May 18, 2023
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
SPR Therapeutics, Inc.

Study Description
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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
Low Back Pain Back Pain Device: SPRINT Peripheral Nerve Stimulation (PNS) System Procedure: Standard interventional management of low back pain Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Reduction in average pain intensity [ 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.

  2. Study-Related Adverse Events (AEs) [ Time Frame: During the Medial Branch Block procedure ]
    Occurrence and type of study-related AEs

  3. Study-Related Adverse Events (AEs) [ Time Frame: During the Lead Placement procedure (SOT) ]
    Occurrence and type of study-related AEs

  4. Study-Related Adverse Events (AEs) [ Time Frame: 1-week post-SOT ]
    Occurrence and type of study-related AEs

  5. Study-Related Adverse Events (AEs) [ Time Frame: 2-weeks post-SOT ]
    Occurrence and type of study-related AEs

  6. Study-Related Adverse Events (AEs) [ Time Frame: 3-weeks post-SOT ]
    Occurrence and type of study-related AEs

  7. Study-Related Adverse Events (AEs) [ Time Frame: 4-weeks post-SOT ]
    Occurrence and type of study-related AEs

  8. Study-Related Adverse Events (AEs) [ Time Frame: 5-weeks post-SOT ]
    Occurrence and type of study-related AEs

  9. Study-Related Adverse Events (AEs) [ Time Frame: 6-weeks post-SOT ]
    Occurrence and type of study-related AEs

  10. Study-Related Adverse Events (AEs) [ Time Frame: 7-weeks post-SOT ]
    Occurrence and type of study-related AEs

  11. Study-Related Adverse Events (AEs) [ Time Frame: 8-weeks post-SOT ]
    Occurrence and type of study-related AEs

  12. Study-Related Adverse Events (AEs) [ Time Frame: 3-months post-SOT ]
    Occurrence and type of study-related AEs

  13. Study-Related Adverse Events (AEs) [ Time Frame: 6-months post-SOT ]
    Occurrence and type of study-related AEs

  14. Study-Related Adverse Events (AEs) [ Time Frame: 9-months post-SOT ]
    Occurrence and type of study-related AEs

  15. Study-Related Adverse Events (AEs) [ Time Frame: 12-months post-SOT ]
    Occurrence and type of study-related AEs

  16. Study-Related Adverse Events (AEs) [ Time Frame: 18-months post-SOT ]
    Occurrence and type of study-related AEs

  17. Study-Related Adverse Events (AEs) [ Time Frame: 24-months post-SOT ]
    Occurrence and type of study-related AEs


Secondary Outcome Measures :
  1. Reduction in pain interference [ 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.

  2. Reduction in disability [ 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.

  3. Durability of reductions in pain intensity [ 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.

  4. Reduction in worst pain intensity [ 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.

  5. Patient Global Impression of Change [ 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.

  6. Change in health-related quality of life [ 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".

  7. Change in analgesic medication usage [ Time Frame: Baseline, 3-months after SOT ]
    Analgesic medication consumption will be collected.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246281


Contacts
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Contact: Lauren Easley 844-378-9108 leasley@sprtherapeutics.com

Locations
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Sponsors and Collaborators
SPR Therapeutics, Inc.
United States Department of Defense
More Information
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Additional Information:

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Responsible Party: SPR Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04246281    
Other Study ID Numbers: 0151-CSP-000
CDMRP-PR170708 ( Other Grant/Funding Number: Department of Defense )
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by SPR Therapeutics, Inc.:
Electrical Stimulation
Neuromodulation
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations