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

Primary Purpose

Low Back Pain, Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPRINT Peripheral Nerve Stimulation (PNS) System
Standard interventional management of low back pain
Sponsored by
SPR Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Electrical Stimulation, Neuromodulation

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Chronic low back pain

Key Exclusion Criteria:

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

Sites / Locations

  • University of Arkansas for Medical SciencesRecruiting
  • IPM Medical GroupRecruiting
  • Denver Back Pain SpecialistsRecruiting
  • International Spine, Pain & Performance CenterRecruiting
  • Emory UniversityRecruiting
  • Northwest Speciality HospitalRecruiting
  • Millennium Pain Center
  • Sinai Hospital of BaltimoreRecruiting
  • Forest Health Medical Center
  • Premier Pain CentersRecruiting
  • Duke UniversityRecruiting
  • Center for Clinical ResearchRecruiting
  • The Ohio State UniversityRecruiting
  • Main Line SpineRecruiting
  • WellSpan Interventional Pain SpecialistsRecruiting
  • Carolinas Center for Advanced Management of Pain
  • Institute of Precision Pain MedicineRecruiting
  • University of UtahRecruiting
  • Virginia iSpine PhysiciansRecruiting
  • Hunter Holmes McGuire Veterans Affairs Medical CenterRecruiting
  • Spine and Nerve Center of St. Francis HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1: Peripheral Nerve Stimulation (PNS)

Group 2: Standard Interventional Management (Standard of Care)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Reduction in average pain intensity
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.
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs

Secondary Outcome Measures

Reduction in pain interference
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.
Reduction in disability
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.
Durability of reductions in pain intensity
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.
Reduction in worst pain intensity
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.
Patient Global Impression of Change
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.
Change in health-related quality of life
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".
Change in analgesic medication usage
Analgesic medication consumption will be collected.

Full Information

First Posted
December 19, 2019
Last Updated
September 6, 2023
Sponsor
SPR Therapeutics, Inc.
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04246281
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SPR Therapeutics, Inc.
Collaborators
United States Department of Defense

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Back Pain
Keywords
Electrical Stimulation, Neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Peripheral Nerve Stimulation (PNS)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2: Standard Interventional Management (Standard of Care)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
SPRINT Peripheral Nerve Stimulation (PNS) System
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Standard interventional management of low back pain
Intervention Description
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 Measure Information:
Title
Reduction in average pain intensity
Description
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.
Time Frame
Up to 3-months after Start of Therapy (SOT)
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
During the Medial Branch Block procedure
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
During the Lead Placement procedure (SOT)
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
1-week post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
2-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
3-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
4-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
5-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
6-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
7-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
8-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
3-months post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
6-months post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
9-months post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
12-months post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
18-months post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
24-months post-SOT
Secondary Outcome Measure Information:
Title
Reduction in pain interference
Description
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.
Time Frame
Baseline, 3-months after SOT
Title
Reduction in disability
Description
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.
Time Frame
Baseline, 3-months after SOT
Title
Durability of reductions in pain intensity
Description
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.
Time Frame
Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT
Title
Reduction in worst pain intensity
Description
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.
Time Frame
Baseline, 3-months after SOT
Title
Patient Global Impression of Change
Description
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.
Time Frame
3-months after SOT
Title
Change in health-related quality of life
Description
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".
Time Frame
Baseline, 3-months after SOT
Title
Change in analgesic medication usage
Description
Analgesic medication consumption will be collected.
Time Frame
Baseline, 3-months after SOT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Chronic low back pain Key Exclusion Criteria: Body Mass Index (BMI) > 40 Prior lumbar surgery Implanted electronic device Pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Easley
Phone
844-378-9108
Email
leasley@sprtherapeutics.com
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shellah Rogers, RN
Phone
501-614-2086
Email
scrogers@uams.edu
First Name & Middle Initial & Last Name & Degree
Erika Petersen, MD
Facility Name
IPM Medical Group
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kat Abtahi
Phone
925-478-5488
Email
kabtahi@boomeranghc.com
First Name & Middle Initial & Last Name & Degree
Kasra Amirdelfan, MD
Facility Name
Denver Back Pain Specialists
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josephine Steinbrecher
Phone
303-327-5511
Ext
319
Email
josephine@denverpaininstitute.com
First Name & Middle Initial & Last Name & Degree
Drew Trainor, DO
Facility Name
International Spine, Pain & Performance Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Bower
Phone
202-808-8295
Email
kbower@isppcenter.com
First Name & Middle Initial & Last Name & Degree
Mehul Desai, MD, MPH
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Vernon
Phone
404-778-8099
Email
ivernon@emory.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Feenstra, MD
Facility Name
Northwest Speciality Hospital
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Natarajan
Phone
208-664-0291
Email
Jennifer.Natarajan@NWSH.com
First Name & Middle Initial & Last Name & Degree
Jessica Jameson, MD
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Individual Site Status
Completed
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seanne Facho
Phone
410-601-0960
Email
sfacho@lifebridgehealth.org
First Name & Middle Initial & Last Name & Degree
Thomas Lee, MD
Facility Name
Forest Health Medical Center
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48198
Country
United States
Individual Site Status
Withdrawn
Facility Name
Premier Pain Centers
City
Shrewsbury
State/Province
New Jersey
ZIP/Postal Code
07702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelle Mercado
Phone
732-307-3500
Email
NMercado@treatingpain.com
First Name & Middle Initial & Last Name & Degree
Sean Li, MD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Spell, CCRP
Phone
919-681-4937
Email
allison.spell@duke.edu
First Name & Middle Initial & Last Name & Degree
Nandan Lad, MD, PhD
Facility Name
Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Blankenship
Phone
336-765-6181
Ext
142
Email
EBlankenship@ccrpain.com
First Name & Middle Initial & Last Name & Degree
Christopher Gilmore, MD
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
McKenna Carr, BS
Phone
614-366-1945
Email
McKenna.Carr@osumc.edu
First Name & Middle Initial & Last Name & Degree
Tristan Weaver, MD
Facility Name
Main Line Spine
City
King Of Prussia
State/Province
Pennsylvania
ZIP/Postal Code
19406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl Pugh
Phone
610-337-3111
Ext
173
Email
cherylp@mainlinespine.com
First Name & Middle Initial & Last Name & Degree
Scott Davidoff, MD
Facility Name
WellSpan Interventional Pain Specialists
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17402
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Libell, MS
Phone
717-851-7634
Email
nlibell@wellspan.org
First Name & Middle Initial & Last Name & Degree
Rajat Mathur, MD
Facility Name
Carolinas Center for Advanced Management of Pain
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Withdrawn
Facility Name
Institute of Precision Pain Medicine
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candace Suckey
Phone
361-387-0046
Email
candace@ippmcc.com
First Name & Middle Initial & Last Name & Degree
Mitchell Engle, MD, PhD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madelaine Littell
Phone
801-587-1436
Email
Madelaine.Littell@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Zachary McCormick, MD
Facility Name
Virginia iSpine Physicians
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devon Withers
Phone
804-330-2611
Ext
4
Email
crc2@vaispine.com
First Name & Middle Initial & Last Name & Degree
Michael DePalma, MD
Facility Name
Hunter Holmes McGuire Veterans Affairs Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Levetta Frasier, RN
Phone
804-675-5188
Email
Levetta.Frasier@va.gov
First Name & Middle Initial & Last Name & Degree
Denise Lester, MD
Facility Name
Spine and Nerve Center of St. Francis Hospital
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Young, RN, BSN
Phone
304-347-6144
Email
Amy.Young@ThomasHealth.org
First Name & Middle Initial & Last Name & Degree
Timothy Deer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.SPRINTBackPainStudy.com
Description
Study Website
URL
http://www.sprintpns.com
Description
Sponsor's Website

Learn more about this trial

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

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