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

Study Overview
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Brief Summary
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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

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

Conditions
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Neuritis, Radiofrequency Ablation

Intervention / Treatment
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* Drug: Dexamethasone 4 mg/ml
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each patient serves as his or her own control. Investigators are recruiting patients who are undergoing bilateral procedures. Each patient will receive dexamethasone at each lesion site post-ablation on one side, and placebo (saline) on the other.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation | Drug: Dexamethasone 4 mg/ml<br>* dexamethasone 4 milligram given post-ablation at each lesion site<br>|
| Placebo Comparator: Placebo<br>Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation | Drug: Normal saline<br>* Placebo, normal saline administered post-ablation at each lesion site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-ablation neuritis |  | 4 weeks |