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

Phase 4

Terminated

• Conditions: Radiofrequency Ablation; Neuritis
• Interventions: Drug: Dexamethasone 4 mg/ml; Drug: Normal saline

• Registration Number: NCT03247413
• Lead Sponsor: Johns Hopkins University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-11
• Study Start: 2019-09-01
• Primary Completion: 2022-10-14
• Study Completion: 2022-10-14
• Results First Submitted: 2023-10-06
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-01
• Last Update Submitted: 2024-01-01
• Results First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone 4 mg/ml	Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation
Placebo	Normal saline	Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation

Primary Outcome Measures

Name	Time	Method
Number of Lesions With Post-Ablation Neuritis	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.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States