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Device

Peripheral Nerve Stimulation for Back Pain

N/A
Waitlist Available
Research Sponsored by SPR Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic low back pain
Chronic low back pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6-months after sot, 9-months after sot, 12-months after sot, 18-months after sot, 24 months after sot
Awards & highlights

Study Summary

This trial will compare two treatments for back pain, one standard and one involving electrical stimulation.

Who is the study for?
This trial is for individuals with chronic low back pain. Participants should not have a BMI over 40, any previous lumbar surgery, implanted electronic devices, or be pregnant.Check my eligibility
What is being tested?
The study compares standard treatments for back pain to the SPRINT Peripheral Nerve Stimulation (PNS) System which delivers electrical stimulation to nerves in the lower back and is FDA-cleared for up to 60 days use.See study design
What are the potential side effects?
Potential side effects of the SPRINT PNS system may include discomfort at the stimulation site, skin irritation, and temporary pain increase. Standard care side effects vary based on specific treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have long-term lower back pain.
Select...
I have had lower back pain for a long time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6-months after sot, 9-months after sot, 12-months after sot, 18-months after sot, 24 months after sot
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-months after sot, 9-months after sot, 12-months after sot, 18-months after sot, 24 months after sot for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in average pain intensity
Study-Related Adverse Events (AEs)
Secondary outcome measures
Change in analgesic medication usage
Change in health-related quality of life
Durability of reductions in pain intensity
+4 more

Trial Design

2Treatment groups
Active Control
Group I: Group 1: Peripheral Nerve Stimulation (PNS)Active Control1 Intervention
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.
Group II: Group 2: Standard Interventional Management (Standard of Care)Active Control1 Intervention
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).

Find a Location

Who is running the clinical trial?

SPR Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
545 Total Patients Enrolled
1 Trials studying Back Pain
166 Patients Enrolled for Back Pain
United States Department of DefenseFED
861 Previous Clinical Trials
226,964 Total Patients Enrolled
4 Trials studying Back Pain
309 Patients Enrolled for Back Pain

Media Library

SPRINT Peripheral Nerve Stimulation (PNS) System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04246281 — N/A
Back Pain Research Study Groups: Group 1: Peripheral Nerve Stimulation (PNS), Group 2: Standard Interventional Management (Standard of Care)
Back Pain Clinical Trial 2023: SPRINT Peripheral Nerve Stimulation (PNS) System Highlights & Side Effects. Trial Name: NCT04246281 — N/A
SPRINT Peripheral Nerve Stimulation (PNS) System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04246281 — N/A
Back Pain Patient Testimony for trial: Trial Name: NCT04246281 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to join this trial?

"As indicated on clinicaltrials.gov, this research is actively recruiting participants. The trial was initially advertised on June 17th 2020 and subject to the most recent update six months afterwards in October 2022."

Answered by AI

To what extent are hospitals participating in this research endeavor?

"Currently, 17 clinical trial sites are enrolling patients for this medical study. These locations span from Baltimore, King Of Prussia and Durham to other cities throughout the nation. It is recommended that you select a nearby site in order to reduce out of pocket travel expenses when participating."

Answered by AI

What criteria must participants meet in order to be eligible for this clinical research?

"This medical trial is accepting applications from participants aged 21 to 75 who have been suffering with chronic low back pain. A total of 230 patients will be enrolled in the study."

Answered by AI

Does this clinical research accept participants aged forty-five or older?

"This trial has a restricted age range, allowing only those between 21 and 75 to apply. There are 11 studies available for persons below the legal age of adulthood and 264 options for adults 65 years old or older."

Answered by AI

What aims does this research endeavor hope to accomplish?

"The primary outcome that SPR Therapeutics, Inc., the study sponsor, intends to measure within a 3-month period after Initial Therapy (SOT) is Study-Related Adverse Events (AEs). Additionally, secondary factors such as Durability of Reduction in Pain Intensity which will be assessed via question 5 from Brief Pain Inventory's Short Form (BPI-5), where 0 denotes no pain and 10 signifies worst imaginable agony; Disability Diminution assessed by Oswestry Disability Index (ODI) with its 0 to 5 rating scale indicating increasing impairment; and Worst Possible Aches' Abatement evaluated using BPI-"

Answered by AI

How many participants are accepted in this research endeavor?

"In order to properly implement this study, SPR Therapeutics Inc. must enlist 230 qualified participants. The trial will be hosted at two different locations: Sinai Hospital of Baltimore in Baltimore and Main Line Spine in King Of Prussia, Pennsylvania."

Answered by AI

Who else is applying?

What state do they live in?
Utah
Maryland
North Carolina
Other
How old are they?
18 - 65
What site did they apply to?
Center for Clinical Research
University of Utah
IPM Medical Group
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+

Why did patients apply to this trial?

Pain. Lots of pain. 30 years with chronic low back pain, 3 surgeries... My doctor recommended this procedure but insurance would not approve, so still in pain.
PatientReceived 1 prior treatment
Chronic lower back pain. I have had three lower back surgeries fusion of L3,L4, an L5. With three neck surgeries.
PatientReceived no prior treatments
I have dealt with severe back pain for app30 years. It is getting progressively worse and I would like to be able to enjoy my grandchildren.
PatientReceived no prior treatments
~74 spots leftby Mar 2026