NCT03247413

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-09-01
• Primary completion: 2022-10-14
• Completion: 2022-10-14
• First posted: 2017-08-11
• Last updated: 2024-01-05
• Results posted: 2024-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study