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

NCT03247413 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-01-05

Study results available
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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

Conditions

  • Neuritis
  • Radiofrequency Ablation

Interventions

DRUG

Dexamethasone 4 mg/ml

dexamethasone 4 milligram given post-ablation at each lesion site

DRUG

Normal saline

Placebo, normal saline administered post-ablation at each lesion site

Sponsors & Collaborators

Principal Investigators

  • Akhil Chhatre, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-10-14
Completion
2022-10-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03247413 on ClinicalTrials.gov