Clinical trial NCT04246281: The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain
Official title: A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Back Pain
Keywords: Electrical Stimulation
Neuromodulation
Lead sponsor: SPR Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2020-01-29
Enrollment: 230
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: Key Inclusion Criteria:

* Chronic low back pain

Key Exclusion Criteria:

* Body Mass Index (BMI) \> 40
* Prior lumbar surgery
* Implanted electronic device
* Pregnant

Primary outcomes:
measure: Reduction in average pain intensity
timeFrame: Up to 3-months after Start of Therapy (SOT)
measure: Study-Related Adverse Events (AEs)
timeFrame: During the Medial Branch Block procedure
measure: Study-Related Adverse Events (AEs)
timeFrame: During the Lead Placement procedure (SOT)
measure: Study-Related Adverse Events (AEs)
timeFrame: 1-week post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 2-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 3-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 4-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 5-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 6-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 7-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 8-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 3-months post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 6-months post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 9-months post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 12-months post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 18-months post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 24-months post-SOT
Secondary outcomes:
measure: Reduction in pain interference
timeFrame: Baseline, 3-months after SOT
measure: Reduction in disability
timeFrame: Baseline, 3-months after SOT
measure: Durability of reductions in pain intensity
timeFrame: Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT
measure: Reduction in worst pain intensity
timeFrame: Baseline, 3-months after SOT
measure: Patient Global Impression of Change
timeFrame: 3-months after SOT
measure: Change in health-related quality of life
timeFrame: Baseline, 3-months after SOT
measure: Change in analgesic medication usage
timeFrame: Baseline, 3-months after SOT
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Walnut Creek
country: United States
facility: IPM Medical Group
state: California
city: Greenwood Village
country: United States
facility: Denver Back Pain Specialists
state: Colorado
city: Washington
country: United States
facility: International Spine, Pain & Performance Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Post Falls
country: United States
facility: Northwest Speciality Hospital
state: Idaho
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Shrewsbury
country: United States
facility: Premier Pain Centers
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: King Of Prussia
country: United States
facility: Main Line Spine
state: Pennsylvania
city: Corpus Christi
country: United States
facility: Institute of Precision Pain Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia iSpine Physicians
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire Veterans Affairs Medical Center
state: Virginia
city: Charleston
country: United States
facility: Spine and Nerve Center of St. Francis Hospital
state: West Virginia
Study officials:
References: