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NCT03179202 · ClinicalTrials.gov registry record · NA
Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)
A NA study of Low Back Pain and Back Pain, sponsored by SPR Therapeutics.
- Completed
- Registry status
- NA
- Development phase
- 166
- Enrollment target
- 8
- Study locations
NCT03179202: Completed NA study of Low Back Pain and Back Pain, sponsored by SPR Therapeutics.
NCT03179202 is a NA study of Low Back Pain and Back Pain that has completed, run by SPR Therapeutics. The registered enrollment target is 166 participants, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (67% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03179202, a NA study of Low Back Pain and Back Pain, has completed, sponsored by SPR Therapeutics.
- COMPLETED
- Registry status
- NA
- Development phase
- 166 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to evaluate the effectiveness of electrical stimulation (low levels of electricity) on low back pain. This study involves the SPRINT Peripheral Nerve Stimulation (PNS) system. The System delivers mild electrical stimulation to the nerves in the low back. The System includes up to four small wires (called "Leads") that are placed through the skin into the muscles in the low back. The wires attach to device(s) worn on the body that deliver stimulation (called Stimulators).
Primary Outcome
All subjects were asked to complete daily diaries to record their average pain intensity on each day of a 7-day period. The pain intensity question was excerpted from the Brief Pain Inventory-Short Form Question 5 (BPI-5). The BPI-5 uses an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." For each subject, the mean score for the baseline and end of treatment (EOT) diary periods were calculated and percent reduction was determined. S
Conditions Studied
Interventions
- DEVICE SPRINT Peripheral Nerve Stimulation (PNS) System
Study Locations (8)
North Carolina
- Duke University Medical Center - Durham
- Center for Clinical Research - Winston-Salem
Arizona
- Hope Research Institute - Peoria
California
- Integrated Pain Management Medical Group - Walnut Creek
District of Columbia
- International Spine, Pain and Performance Center - Washington D.C.
New Jersey
- Premier Pain Centers - Shrewsbury
Virginia
- Virginia iSpine Physicians - Richmond
West Virginia
- The Spine and Nerve Center of St. Francis Hospital - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2017-06-23 |
| Est. Completion | 2021-05-11 |
| Phase | NA |
What the finished NCT03179202 record still lists
NCT03179202 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Low Back Pain appearing as the primary indexed condition, and to 1 intervention - of which SPRINT Peripheral Nerve Stimulation (PNS) System is the first listed.
NCT03179202 lists 8 locations in 7 states (North Carolina, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT03179202 about?
NCT03179202 is a clinical study titled "Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)". The purpose of this study is to evaluate the effectiveness of electrical stimulation (low levels of electricity) on low back pain. This study involves the SPRINT Peripheral Nerve Stimulation (PNS) system. The System delivers mild electrical stimulation to the nerves in the low back. The System inclu...
What is the current status of trial NCT03179202?
This trial is currently completed. It is a NA study. The enrollment target is 166 participants. The study started on 2017-06-23. Estimated completion is 2021-05-11.
What conditions does trial NCT03179202 study?
This clinical trial studies the following conditions: Low Back Pain, Back Pain.
What interventions are being tested in trial NCT03179202?
The interventions under investigation include: SPRINT Peripheral Nerve Stimulation (PNS) System (DEVICE).
Who is sponsoring clinical trial NCT03179202?
This trial is sponsored by SPR Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03179202 being conducted?
This trial has 8 study locations across Arizona, California, District of Columbia, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03179202's enrollment target sits among peer trials
166 38th of 122 higher than 85 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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