Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    SPRINT, Mehul Desai | Low Back Pain | Washington, District of Columbia, U.S.
Previous Study | Return to List | Next Study

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 : June 29, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
SPR Therapeutics, Inc.

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

Layout table for study information
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

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.




Primary Outcome Measures :
  1. Reduction in average pain intensity and/or reduction in disability [ 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. 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.

  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 average pain intensity [ Time Frame: 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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".

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



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.


Layout table for eligibility information
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

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
Layout table for location contacts
Contact: Lauren Easley 844-378-9108 leasley@sprtherapeutics.com

Locations
Layout table for location information
United States, Colorado
Denver Back Pain Specialists Recruiting
Greenwood Village, Colorado, United States, 80111
Contact: Sara Light    303-327-5511 ext 319    SLight@denverbackpainspecialists.com   
Principal Investigator: Drew Trainor, DO         
United States, District of Columbia
International Spine, Pain & Performance Center Recruiting
Washington, District of Columbia, United States, 20006
Contact: Evelynne Morris, MS    202-808-8295    emorris@isppcenter.com   
Principal Investigator: Mehul Desai, MD, MPH         
United States, Illinois
Millennium Pain Center Recruiting
Bloomington, Illinois, United States, 61704
Contact: Stephanie Wolf, CCRC    309-662-4321    swolf@treatingpain.com   
Principal Investigator: Ramsin Benyamin, MD         
United States, New Jersey
Premier Pain Centers Recruiting
Shrewsbury, New Jersey, United States, 07702
Contact: Nelle Mercado    732-307-3500    NMercado@treatingpain.com   
Principal Investigator: Sean Li, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Allison Spell, CCRP    919-681-4937    allison.spell@duke.edu   
Principal Investigator: Thomas Hopkins, MD, MBA         
Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Danielle Cox    336-765-6181 ext 185    dcox@ccrpain.com   
Principal Investigator: Christopher Gilmore, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Caitlin Hatten    513-633-5422    Caitlin.Hatten@osumc.edu   
Principal Investigator: Tristan Weaver, MD         
United States, South Carolina
Carolinas Center for Advanced Management of Pain Recruiting
Greenville, South Carolina, United States, 29615
Contact: Kim Williams    864-316-2587    kimw2685@gmail.com   
Principal Investigator: J. Kelby Hutcheson, MD         
United States, Virginia
Virginia iSpine Physicians Recruiting
Richmond, Virginia, United States, 23235
Contact: Karen Wilson    804-330-0303 ext 4    crc@vaispine.com   
Principal Investigator: Michael DePalma, MD         
United States, West Virginia
Spine and Nerve Center of St. Francis Hospital Recruiting
Charleston, West Virginia, United States, 25301
Contact: Amy Young, RN, BSN    304-347-6144    Amy.Young@ThomasHealth.org   
Principal Investigator: Timothy Deer, MD         
Sponsors and Collaborators
SPR Therapeutics, Inc.
United States Department of Defense
Additional Information:
Layout table for additonal information
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: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations