Neuritis, Radiofrequency Ablation
Conditions
Brief 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
Interventions
dexamethasone 4 milligram given post-ablation at each lesion site
DRUGNormal saline
Placebo, normal saline administered post-ablation at each lesion site
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The patient, care providers, and principle investigator will be blinded.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions With Post-Ablation Neuritis | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 28 |
Baseline characteristics
| Characteristic | Dexamethasone/Placebo | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 17 Participants | — |
| Age, Categorical Between 18 and 65 years | 18 Participants | — |
| Age, Continuous | 58.8 years STANDARD_DEVIATION 15.83 | — |
| Post-neurotomy pain incidence | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 35 Participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
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.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone | Number of Lesions With Post-Ablation Neuritis | 3 lesions |
| Placebo | Number of Lesions With Post-Ablation Neuritis | 20 lesions |