Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation

January 1, 2024 updated by: Johns Hopkins University
Chronic neck and back pain has become one of the leading causes of disability and loss of productivity. For many patients with facet or sacroiliac joint mediated pain who have responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe procedure with minimal risk of adverse events. However, with any procedure involving damage to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The investigators will test the hypothesis that dexamethasone injection delivered at the time of lesion effectively prevents the development of post-ablation neuritis through a placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic, lumbar, and sacroiliac joint radiofrequency denervations

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with a diagnosis of either cervical, thoracic, or lumbar facet or sacroiliac joint pain who have responded to medial branch blocks and are already scheduled for bilateral radiofrequency ablations
  • age greater than 18 years old
  • English speaking

Exclusion Criteria:

  • patient not previously scheduled for radiofrequency ablation of the cervical, thoracic, or lumbar facets, or sacroiliac joints
  • on anticoagulation
  • have a pacemaker
  • age less than 18 years old
  • non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation
Drug: Dexamethasone 4 mg/ml
dexamethasone 4 milligram given post-ablation at each lesion site
Placebo Comparator: Placebo
Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation
Drug: Normal saline
Placebo, normal saline administered post-ablation at each lesion site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Lesions With Post-Ablation Neuritis
Time Frame: 4 weeks
Each patient had 2 lesions. One Lesion was treated with dexamethasone. The other lesion was treated with placebo. We then looked at the number of lesions that developed post-ablation neuritis.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Akhil Chhatre, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

October 14, 2022

Study Completion (Actual)

October 14, 2022

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00113297

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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