Study Summary
This trial will compare two treatments for back pain, one standard and one involving electrical stimulation.
- Back Pain
- Lower Back Pain
Treatment Effectiveness
Effectiveness Progress
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
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 21 - 75 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Maryland | 66.7% |
| Utah | 33.3% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Utah | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
Frequently Asked Questions
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." - Anonymous Online Contributor
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
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
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
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
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