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Study has been halted prematurely
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation |
|
| Placebo | Placebo Comparator | Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 4 mg/ml | Drug | dexamethasone 4 milligram given post-ablation at each lesion site |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akhil Chhatre, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34793638 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone/Placebo | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | lesions | 4 weeks |
|
1 year
35 participants of the original 63 that were enrolled participated in the study and were at risk of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone/Placebo | Each patient received both the dexamethasone and placebo on alternating sides of the spinal level. One Lesions 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Akhil Chhatre | Johns Hopkins University School of Medicine | 443-997-5476 | achhatr1@jh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2020 | Oct 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009443 | Neuritis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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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.
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The patient, care providers, and principle investigator will be blinded.
| Normal saline | Drug | Placebo, normal saline administered post-ablation at each lesion site |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Post-neurotomy pain incidence | Count of Participants | Participants |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |