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

Radiofrequency Ablation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03247413
• Other study ID #: IRB00113297
• Status: Terminated
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: October 14, 2022

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: October 14, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuritis
• Radiofrequency Ablation

Intervention

Drug:
• Dexamethasone 4 mg/ml
dexamethasone 4 milligram given post-ablation at each lesion site
• Normal saline
Placebo, normal saline administered post-ablation at each lesion site

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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