Trial Outcomes & Findings for Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation (NCT NCT03247413)

NCT ID: NCT03247413

Last Updated: 2024-01-05

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 63 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2024-01-05

Participant Flow

Unit of analysis: Lesions

Participant milestones

Measure	All Study Participants Each patient received both the dexamethasone and placebo on alternating sides of the affected spinal level. One Lesion where dexamethasone 4 milligram is administered post-radiofrequency ablation Dexamethasone 4 mg/ml: dexamethasone 4 milligram given post-ablation at each lesion site On the opposing side, 1 milligram of normal saline was given.
Overall Study STARTED	63 126
Overall Study Received Dexamethasone (4 mg/ml) Intervention	63 126
Overall Study Received Placebo (1 mg Saline) Intervention	63 126
Overall Study COMPLETED	35 70
Overall Study NOT COMPLETED	28 56

Reasons for withdrawal

Measure	All Study Participants Each patient received both the dexamethasone and placebo on alternating sides of the affected spinal level. One Lesion where dexamethasone 4 milligram is administered post-radiofrequency ablation Dexamethasone 4 mg/ml: dexamethasone 4 milligram given post-ablation at each lesion site On the opposing side, 1 milligram of normal saline was given.
Overall Study Lost to Follow-up	28

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Dexamethasone/Placebo n=35 Participants Each patient received bilateral lesions on either side of the spinal level and served as their own control arm. Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation Dexamethasone 4 mg/ml: dexamethasone 4 milligram given post-ablation at each lesion site Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation Normal saline: Placebo, normal saline administered post-ablation at each lesion site
Age, Categorical <=18 years	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=35 Participants
Age, Categorical >=65 years	17 Participants n=35 Participants
Age, Continuous	58.8 years STANDARD_DEVIATION 15.83 • n=35 Participants
Sex: Female, Male Female	15 Participants n=35 Participants
Sex: Female, Male Male	20 Participants n=35 Participants
Region of Enrollment United States	35 Participants n=35 Participants
Post-neurotomy pain incidence	3 Participants n=35 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Dexamethasone n=35 Participants Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation Dexamethasone 4 mg/ml: dexamethasone 4 milligram given post-ablation at each lesion site	Placebo n=35 Participants Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation Normal saline: Placebo, normal saline administered post-ablation at each lesion site
Number of Lesions With Post-Ablation Neuritis	3 lesions	20 lesions

Adverse Events

Dexamethasone/Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Akhil Chhatre

Johns Hopkins University School of Medicine

Phone: 443-997-5476

Email: achhatr1@jh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place