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

NCT ID: NCT03247413

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-10-14

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

Conditions

Neuritis; Radiofrequency Ablation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Dexamethasone

Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation

Group Type: EXPERIMENTAL

Dexamethasone 4 mg/ml

Intervention Type: DRUG

dexamethasone 4 milligram given post-ablation at each lesion site

Placebo

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Placebo, normal saline administered post-ablation at each lesion site

Interventions

Dexamethasone 4 mg/ml

dexamethasone 4 milligram given post-ablation at each lesion site

Intervention Type: DRUG

Normal saline

Placebo, normal saline administered post-ablation at each lesion site

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akhil Chhatre, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

Shustorovich A, AlFarra T, Arel AT, Singh JR, Roemmich RT, Chhatre A. Dexamethasone Effectively Reduces the Incidence of Post-neurotomy Neuropathic Pain: A Randomized Controlled Pilot Study. Pain Physician. 2021 Dec;24(8):517-524.

Reference Type: RESULT

PMID: 34793638 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00113297

Identifier Type: -

Identifier Source: org_study_id