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NCT03601949 · ClinicalTrials.gov registry record · NA
Lateral Branch Cooled Radiofrequency Denervation vs. Conservative Therapy for Sacroiliac Joint Pain
A NA study of Sacroiliac Joint Pain, sponsored by Avanos Medical.
- Completed
- Registry status
- NA
- Development phase
- 210
- Enrollment target
- 15
- Study locations
NCT03601949: Completed NA study of Sacroiliac Joint Pain, sponsored by Avanos Medical.
NCT03601949 is a NA study of Sacroiliac Joint Pain that has completed, run by Avanos Medical. The registered enrollment target is 210 participants, above the 62-participant average among 3 other Sacroiliac Joint Pain trials with a reported enrollment target (239% higher). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03601949, a NA study of Sacroiliac Joint Pain, has completed, sponsored by Avanos Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a prospective, randomized, controlled, multi-center clinical study. Approximately 208 subjects will be enrolled at approximately 12-15 active duty military, veterans' care, and civilian sites. Eligible subjects will be randomized in 1:1 ratio to receive either Sacroiliac denervation using CRF (treatment group) or standard medical management ("SMM," control group).
Primary Outcome
Numeric Rating Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
Conditions Studied
Interventions
- OTHER Medical Management
- DEVICE SInergy Cooled Radiofrequency
Study Locations (15)
North Carolina
- Womack Army Medical Center - Fort Bragg
- The Center for Clinical Research - Winston-Salem
- Wake Forest Baptist Health - Winston-Salem
Maryland
- Shravani Durbhakula - Baltimore
- Walter Reed National Military Medical Center - Bethesda
Virginia
- Lynn Kohan - Charlottesville
- Michael DePalma - Richmond
District of Columbia
- Mehul Desai - Washington D.C.
Illinois
- Millennium Pain Center - Bloomington
Louisiana
- Ochsner Medical Center - New Orleans
Massachusetts
- Brigham and Women's Hospital - Chestnut Hill
New Jersey
- Premier Pain Centers - Shrewsbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2018-06-29 |
| Est. Completion | 2022-06-23 |
| Phase | NA |
What the finished NCT03601949 record still lists
NCT03601949 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 62-participant average among 3 other Sacroiliac Joint Pain trials with a reported enrollment target (239% higher).
The record links to 1 condition, with Sacroiliac Joint Pain appearing as the primary indexed condition, and to 2 interventions - of which Medical Management is the first listed.
NCT03601949 lists 15 locations in 11 states (North Carolina, Maryland, Virginia).
Frequently Asked Questions
What is clinical trial NCT03601949 about?
NCT03601949 is a clinical study titled "Lateral Branch Cooled Radiofrequency Denervation vs. Conservative Therapy for Sacroiliac Joint Pain". This is a prospective, randomized, controlled, multi-center clinical study. Approximately 208 subjects will be enrolled at approximately 12-15 active duty military, veterans' care, and civilian sites. Eligible subjects will be randomized in 1:1 ratio to receive either Sacroiliac denervation using CR...
What is the current status of trial NCT03601949?
This trial is currently completed. It is a NA study. The enrollment target is 210 participants. The study started on 2018-06-29. Estimated completion is 2022-06-23.
What conditions does trial NCT03601949 study?
This clinical trial studies the following conditions: Sacroiliac Joint Pain.
What interventions are being tested in trial NCT03601949?
The interventions under investigation include: Medical Management (OTHER), SInergy Cooled Radiofrequency (DEVICE).
Who is sponsoring clinical trial NCT03601949?
This trial is sponsored by Avanos Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03601949 being conducted?
This trial has 15 study locations across District of Columbia, Illinois, Louisiana, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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