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NCT02002429 · ClinicalTrials.gov registry record · NA

Medial Branch Blocks vs. Intra-articular Injections: Randomized, Controlled Study

A NA study, sponsored by Johns Hopkins University.

Completed
Registry status
NA
Development phase
225
Enrollment target

NCT02002429: Completed NA study, sponsored by Johns Hopkins University.

NCT02002429 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 225 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02002429, a NA study, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
NA
Development phase
225 participants
Enrollment target

Study Summary

Background: Facet interventions are the second most commonly performed procedure in pain clinics throughout the U.S, including in the military. Currently, there is no clear consensus regarding whether intra-articular (IA) blocks or medial branch blocks (facet joint nerve; MBB) are the best way to diagnose and treat facetogenic pain, or even whether or not to perform diagnostic/ prognostic blocks. Hypothesis: IA blocks will provide better relief than MBB, but MBB may better select patients for radiofrequency denervation. Purpose: Objective 1: Determine which "prognostic" block is the best predictor for RF denervation outcome; Objective 2: To determine whether adding steroids to IA or MBB may provide intermediate or long-term benefit to a subset of individuals. Research Design: Randomized, comparative-effectiveness study Methodology /Technical Approach: A total of 225 patients with non-radicular chronic low back pain (LBP) with suspected facetogenic etiology will be randomized in a 2:2:1 ratio to one of 3 groups: Group 1 will receive IA blocks with steroids and LA Group 2 will receive MBB with steroids and LA Group 3 will receive MBB with only saline Those individuals who obtain significant (≥ 50% in groups 1 and 2,3) but temporary (\< 1-month) relief will undergo radiofrequency (RF) denervation at their 1-month follow-up. In group 3, those patients who do not experience pain relief at 1-month will undergo RF denervation regardless of the pain relief they experience (as many practitioners in the military and civilian practices do without diagnostic blocks).1-3 Participants in Groups 1 and 2 who experience prolonged relief from their diagnostic/ therapeutic blocks with LA and steroids will not undergo RF denervation until their pain returns. Those individuals who experience prolonged relief lasting \> 6 months will be given the option of repeating the diagnostic/ therapeutic block. In Groups 1, 2 and 3 patients who experience prolonged relief from the diagnostic

Interventions

  • PROCEDURE Saline injection
  • PROCEDURE Intra-articular injection
  • PROCEDURE Medial branch block

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2014-03
Est. Completion 2017-08
Phase NA

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT02002429

The ClinicalTrials.gov registry entry for NCT02002429 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Saline injection is the first listed.

NCT02002429 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02002429 about?

NCT02002429 is a clinical study titled "Medial Branch Blocks vs. Intra-articular Injections: Randomized, Controlled Study". Background: Facet interventions are the second most commonly performed procedure in pain clinics throughout the U.S, including in the military. Currently, there is no clear consensus regarding whether intra-articular (IA) blocks or medial branch blocks (facet joint nerve; MBB) are the best way to di...

What is the current status of trial NCT02002429?

This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2014-03. Estimated completion is 2017-08.

What interventions are being tested in trial NCT02002429?

The interventions under investigation include: Saline injection (PROCEDURE), Intra-articular injection (PROCEDURE), Medial branch block (PROCEDURE).

Who is sponsoring clinical trial NCT02002429?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.