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
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
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 |
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Johns Hopkins University