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

NCT03247413 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00113297
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Lesions With Post-Ablation Neuritis

  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.

  4 weeks

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation

Drug: Dexamethasone 4 mg/ml

Placebo

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Dexamethasone 4 mg/ml DRUG

dexamethasone 4 milligram given post-ablation at each lesion site

Dexamethasone

Normal saline DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 34793638 RESULT

MeSH Terms

Conditions

Neuritis

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Akhil Chhatre
• Organization: Johns Hopkins University School of Medicine

achhatr1@jh.edu

443-997-5476

Study Officials

• Akhil Chhatre, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient, care providers, and principle investigator will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: September 1, 2019
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2024-01

Locations

US (1)