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

Primary Purpose

Neuritis, Radiofrequency Ablation

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone 4 mg/ml
Normal saline
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neuritis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation

Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation

Outcomes

Primary Outcome Measures

Incidence of post-ablation neuritis

Secondary Outcome Measures

Full Information

First Posted
August 8, 2017
Last Updated
October 14, 2022
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03247413
Brief Title
Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation
Official Title
Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Study has been halted prematurely
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuritis, Radiofrequency Ablation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Each patient serves as his or her own control. Investigators are recruiting patients who are undergoing bilateral procedures. Each patient will receive dexamethasone at each lesion site post-ablation on one side, and placebo (saline) on the other.
Masking
ParticipantCare ProviderInvestigator
Masking Description
The patient, care providers, and principle investigator will be blinded.
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4 mg/ml
Intervention Description
dexamethasone 4 milligram given post-ablation at each lesion site
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Placebo, normal saline administered post-ablation at each lesion site
Primary Outcome Measure Information:
Title
Incidence of post-ablation neuritis
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akhil Chhatre, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34793638
Citation
Shustorovich A, AlFarra T, Arel AT, Singh JR, Roemmich RT, Chhatre A. Dexamethasone Effectively Reduces the Incidence of Post-neurotomy Neuropathic Pain: A Randomized Controlled Pilot Study. Pain Physician. 2021 Dec;24(8):517-524.
Results Reference
derived

Learn more about this trial

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

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