A Phase 4 interventional study of Dexamethasone 4 mg/ml and Normal saline in Neuritis and Radiofrequency Ablation, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Johns Hopkins University · Phase 4, Interventional, and Prevention
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
73 studies on the registry are indexed under Neuritis; 20 are open to participants now.
This study's enrollment of 63 is above the median of 48 across 51 interventional studies indexed under Neuritis.
Browse Neuritis studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation
Drug: Dexamethasone 4 mg/ml
Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation
Drug: Normal saline
Drug page: Dexamethasone
dexamethasone 4 milligram given post-ablation at each lesion site
Placebo, normal saline administered post-ablation at each lesion site
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.
Time frame: 4 weeks
| Milestone | All Study Participants |
|---|---|
| Started | 63 |
| Received dexamethasone (4 mg/ml) intervention | 63 |
| Received placebo (1 mg saline) intervention | 63 |
| Completed | 35 |
| Not completed | 28 |
| Withdrew: Lost to follow-up | 28 |
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.
| lesions | Dexamethasone | Placebo |
|---|---|---|
| Number of Lesions With Post-Ablation Neuritis | 3 | 20 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone/Placebo | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Age, Categorical(Participants) | Dexamethasone/Placebo |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 17 |
| Age, Continuous(years) | Dexamethasone/Placebo |
|---|---|
| Mean | 58.8 ± 15.83 |
| Sex: Female, Male(Participants) | Dexamethasone/Placebo |
|---|---|
| Female | 15 |
| Male | 20 |
| Race and Ethnicity Not Collected(Participants) | Dexamethasone/Placebo |
|---|
| Region of Enrollment(Participants) | Dexamethasone/Placebo |
|---|---|
| United States | 35 |
| Post-neurotomy pain incidence(Participants) | Dexamethasone/Placebo |
|---|---|
| Count of participants | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2019 to primary completion in Oct 2022, 37 months.
Results were first posted in Jan 2024, 1 year 2 months after primary completion.
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This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone