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NCT02329951 · ClinicalTrials.gov registry record
Predictive Factors for LBP Interventional Treatment Outcomes
A clinical trial of Low Back Pain and Lumbar Radiculopathy, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 346
- Enrollment target
- 1
- Study location
NCT02329951 is a study of Low Back Pain and Lumbar Radiculopathy that has completed, run by Johns Hopkins University. The registered enrollment target is 346 participants, below the 501-participant average among 122 other Low Back Pain trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02329951, a study of Low Back Pain and Lumbar Radiculopathy, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 346 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, we are attempting to determine which factors are associated with interventional treatment outcome for LBP (and to what extent). Up to 346 patients with LBP who are considered to be good candidates for therapeutic interventional procedures will be given a complete history and physical exam, which includes the assessment of Waddell signs, and querying them regarding factors shown in non-interventional studies or retrospective studies evaluating interventional treatments to be associated with negative treatment outcomes. These factors include the presence of Waddell and other physical exam signs, opioid use, allergies, psychopathology, concomitant pain conditions, a 6-point Likert scale on expectations, sleep abnormalities, secondary gain (e.g. medical board or litigation), procedure-related pain including from a 1 ml standardized injection, obesity, and smoking history. They will then proceed to undergo their scheduled intervention, which will be limited to epidural steroid injections (ESI), facet blocks and if positive, radiofrequency denervation, and sacroiliac (SI) joint injections. A positive outcome will be defined as 2-point or greater decrease in average pain score at 1-month and a score of \> 3 on a 1-5 Likert satisfaction scale. Those with a positive outcome at 1-month will remain in the study and be followed again at 3-months.
Conditions Studied
Interventions
- PROCEDURE Facet intervention
- PROCEDURE Sacroiliac joint injection
- PROCEDURE Epidural steroid injection
Study Locations (1)
Maryland
- Johns Hopkins School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 346 participants |
| Start Date | 2014-12 |
| Est. Completion | 2021-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02329951
The ClinicalTrials.gov registry entry for NCT02329951 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 346 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 501-participant average among 122 other Low Back Pain trials with a reported enrollment target (31% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Low Back Pain appearing as the primary indexed condition, and to 3 interventions - of which Facet intervention is the first listed.
NCT02329951 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02329951 about?
NCT02329951 is a clinical study titled "Predictive Factors for LBP Interventional Treatment Outcomes". In this study, we are attempting to determine which factors are associated with interventional treatment outcome for LBP (and to what extent). Up to 346 patients with LBP who are considered to be good candidates for therapeutic interventional procedures will be given a complete history and physical ...
What is the current status of trial NCT02329951?
This trial is currently completed. The enrollment target is 346 participants. The study started on 2014-12. Estimated completion is 2021-12.
What conditions does trial NCT02329951 study?
This clinical trial studies the following conditions: Low Back Pain, Lumbar Radiculopathy.
What interventions are being tested in trial NCT02329951?
The interventions under investigation include: Facet intervention (PROCEDURE), Sacroiliac joint injection (PROCEDURE), Epidural steroid injection (PROCEDURE).
Who is sponsoring clinical trial NCT02329951?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02329951 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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