Purpose

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)

Conditions

Eligibility

Eligible Ages
Between 21 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronic low back pain

Exclusion Criteria

  • Body Mass Index (BMI) > 40 - Prior lumbar surgery - Implanted electronic device - Pregnant

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Gail Runnells, RN
501-398-8622
RunnellsGailAnn@uams.edu

IPM Medical Group
Walnut Creek, California 94598
Contact:
Heidi Marshall-Booth
925-478-5490
hbooth@ipmdoctors.com

Denver Back Pain Specialists
Greenwood Village, Colorado 80111
Contact:
Sara Light
303-327-5511
SLight@denverbackpainspecialists.com

International Spine, Pain & Performance Center
Washington, District of Columbia 20006
Contact:
Selma Paul, BS
202-808-8295
spaul@isppcenter.com

Emory University
Atlanta, Georgia 30329
Contact:
Isabelle Vernon
404-778-8099
ivernon@emory.edu

Millennium Pain Center
Bloomington, Illinois 61704
Contact:
Stephanie Wolf, CCRC
309-662-4321
swolf@treatingpain.com

Sinai Hospital of Baltimore
Baltimore, Maryland 21215
Contact:
Rakesh Gupta
410-601-2342
rgupta@lifebridgehealth.org

Premier Pain Centers
Shrewsbury, New Jersey 07702
Contact:
Nelle Mercado
732-307-3500
NMercado@treatingpain.com

Duke University
Durham, North Carolina 27710
Contact:
Allison Spell, CCRP
919-681-4937
allison.spell@duke.edu

Center for Clinical Research
Winston-Salem, North Carolina 27103
Contact:
Emily Blankenship
336-765-6181
EBlankenship@ccrpain.com

The Ohio State University
Columbus, Ohio 43210
Contact:
Alexander Waldron, BA
614-688-9141
Alexander.Waldron@osumc.edu

Main Line Spine
King Of Prussia, Pennsylvania 19406
Contact:
Cheryl Pugh
610-337-3111
cherylp@mainlinespine.com

Institute of Precision Pain Medicine
Corpus Christi, Texas 78414
Contact:
Candace Suckey
361-387-0046
candace@ippmcc.com

University of Utah
Salt Lake City, Utah 84108
Contact:
Madelaine Littell
801-587-1436
Madelaine.Littell@hsc.utah.edu

Virginia iSpine Physicians
Richmond, Virginia 23235
Contact:
Devon Withers
804-330-2611
crc2@vaispine.com

Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia 23249
Contact:
Levetta Frasier, RN
804-675-5188
Levetta.Frasier@va.gov

Spine and Nerve Center of St. Francis Hospital
Charleston, West Virginia 25301
Contact:
Amy Young, RN, BSN
304-347-6144
Amy.Young@ThomasHealth.org

More Details

NCT ID
NCT04246281
Status
Recruiting
Sponsor
SPR Therapeutics, Inc.

Study Contact

Lauren Easley
844-378-9108
leasley@sprtherapeutics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.