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Peripheral Nerve Stimulation for Back Pain
Study Summary
This trial will compare two treatments for back pain, one standard and one involving electrical stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have long-term lower back pain.You have a very high body mass index (BMI).I have long-term lower back pain.I have long-term lower back pain.I have had lower back pain for a long time.You have a pacemaker or other implanted electronic device.I have had surgery on my lower back before.
- Group 1: Group 1: Peripheral Nerve Stimulation (PNS)
- Group 2: Group 2: Standard Interventional Management (Standard of Care)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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."
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-"
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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