The RESET Clinical Trial: SPRINTĀ® Peripheral Nerve Stimulation for the Treatment of Back Pain
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
- Low Back Pain
- Back Pain
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
Arm | Description | Assigned 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. |
|
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). |
|
Recruiting Locations
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
IPM Medical Group
Walnut Creek, California 94598
Walnut Creek, California 94598
Denver Back Pain Specialists
Greenwood Village, Colorado 80111
Greenwood Village, Colorado 80111
International Spine, Pain & Performance Center
Washington, District of Columbia 20006
Washington, District of Columbia 20006
Millennium Pain Center
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
Baltimore, Maryland 21215
Premier Pain Centers
Shrewsbury, New Jersey 07702
Shrewsbury, New Jersey 07702
Duke University
Durham, North Carolina 27710
Durham, North Carolina 27710
Center for Clinical Research
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
The Ohio State University
Columbus, Ohio 43210
Columbus, Ohio 43210
Main Line Spine
King Of Prussia, Pennsylvania 19406
King Of Prussia, Pennsylvania 19406
Institute of Precision Pain Medicine
Corpus Christi, Texas 78414
Corpus Christi, Texas 78414
University of Utah
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
Virginia iSpine Physicians
Richmond, Virginia 23235
Richmond, Virginia 23235
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia 23249
Richmond, Virginia 23249
Spine and Nerve Center of St. Francis Hospital
Charleston, West Virginia 25301
Charleston, West Virginia 25301
More Details
- NCT ID
- NCT04246281
- Status
- Recruiting
- Sponsor
- SPR Therapeutics, Inc.