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

Low Back Pain Clinical Trial

Official title:

A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04246281
• Other study ID #: 0151-CSP-000
• Secondary ID: CDMRP-PR170708
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 17, 2020
• Est. completion date: February 2027

Study information

• Verified date: June 2024
• Source: SPR Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Est. completion date: February 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• Chronic low back pain

Key Exclusion Criteria:

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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).

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Millennium Pain Center	Bloomington	Illinois
United States	Spine and Nerve Center of St. Francis Hospital	Charleston	West Virginia
United States	The Ohio State University	Columbus	Ohio
United States	Institute of Precision Pain Medicine	Corpus Christi	Texas
United States	Duke University	Durham	North Carolina
United States	Denver Back Pain Specialists	Greenwood Village	Colorado
United States	Main Line Spine	King Of Prussia	Pennsylvania
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Northwest Speciality Hospital	Post Falls	Idaho
United States	Hunter Holmes McGuire Veterans Affairs Medical Center	Richmond	Virginia
United States	Virginia iSpine Physicians	Richmond	Virginia
United States	University of Utah	Salt Lake City	Utah
United States	Premier Pain Centers	Shrewsbury	New Jersey
United States	IPM Medical Group	Walnut Creek	California
United States	International Spine, Pain & Performance Center	Washington	District of Columbia
United States	Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
SPR Therapeutics, Inc.	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3-months after Start of Therapy (SOT)
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	During the Medial Branch Block procedure
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	During the Lead Placement procedure (SOT)
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	1-week post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	2-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	3-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	4-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	5-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	6-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	7-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	8-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	3-months post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	6-months post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	9-months post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	12-months post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	18-months post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	24-months post-SOT
Secondary	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.	Baseline, 3-months after SOT
Secondary	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.	Baseline, 3-months after SOT
Secondary	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.	Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT
Secondary	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.	Baseline, 3-months after SOT
Secondary	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.	3-months after SOT
Secondary	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".	Baseline, 3-months after SOT
Secondary	Change in analgesic medication usage	Analgesic medication consumption will be collected.	Baseline, 3-months after SOT

External Links

•   Sponsor's Website