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Clinical Trials/NCT03247413
NCT03247413
Terminated
Phase 4

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

Johns Hopkins University1 site in 1 country63 target enrollmentSeptember 1, 2019

Overview

Phase
Phase 4
Intervention
Dexamethasone 4 mg/ml
Conditions
Neuritis
Sponsor
Johns Hopkins University
Enrollment
63
Locations
1
Primary Endpoint
Number of Lesions With Post-Ablation Neuritis
Status
Terminated
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
October 14, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Dexamethasone

Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation

Intervention: Dexamethasone 4 mg/ml

Placebo

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

Intervention: Normal saline

Outcomes

Primary Outcomes

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.

Study Sites (1)

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