drugset / Trial / NCT03247413

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

NCT03247413 ↗

Phase 4 Terminated 63 enrolled Johns Hopkins University
RandomizedParallel-groupTriple-blindPrevention

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

Timeline

Start
2019-09-01
Primary completion
2022-10-14
Completion
2022-10-14

Outcome

Met primary endpoint

Stopped: “Study has been halted prematurely”

paper There was a statistically significant reduction in the incidence of post-neurotomy pain in the steroid group vs the control group PMID 34793638 ↗

paper 20/35 control group vs 3/35 steroid group, P < 0.001 PMID 34793638 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 4 mg —

Indications