Group 1: Peripheral Nerve Stimulation (PNS) for Back Pain

Phase-Based Progress Estimates
Emory University, Atlanta, GABack Pain+1 MoreStandard interventional management of low back pain - Procedure
21 - 75
All Sexes
What conditions do you have?

Study Summary

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

Eligible Conditions
  • Back Pain
  • Lower Back Pain

Treatment Effectiveness

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT

24-months post-SOT
Study-Related Adverse Events (AEs)
3-months after SOT
Patient Global Impression of Change
Baseline, 3-months after SOT
Change in analgesic medication usage
Change in health-related quality of life
Reduction in disability
Reduction in pain interference
Reduction in worst pain intensity
Month 24
Durability of reductions in pain intensity
Up to 3-months after Start of Therapy (SOT)
Reduction in average pain intensity

Trial Safety

Trial Design

2 Treatment Groups

Group 1: Peripheral Nerve Stimulation (PNS)
1 of 2
Group 2: Standard Interventional Management (Standard of Care)
1 of 2

Active Control

230 Total Participants · 2 Treatment Groups

Primary Treatment: Group 1: Peripheral Nerve Stimulation (PNS) · No Placebo Group · N/A

Group 1: Peripheral Nerve Stimulation (PNS)
ActiveComparator Group · 1 Intervention: SPRINT Peripheral Nerve Stimulation (PNS) System · Intervention Types: Device
Group 2: Standard Interventional Management (Standard of Care)
ActiveComparator Group · 1 Intervention: Standard interventional management of low back pain · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6-months after sot, 9-months after sot, 12-months after sot, 18-months after sot, 24 months after sot

Who is running the clinical trial?

SPR Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
705 Total Patients Enrolled
1 Trials studying Back Pain
166 Patients Enrolled for Back Pain
United States Department of DefenseFED
791 Previous Clinical Trials
212,993 Total Patients Enrolled
4 Trials studying Back Pain
350 Patients Enrolled for Back Pain

Eligibility Criteria

Age 21 - 75 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are experiencing long-term pain in your lower back.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
University of Utah100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
How many prior treatments have patients received?

Frequently Asked Questions

Are there still opportunities to join this trial?

"As indicated on, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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-" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.