A Phase 4 interventional study of CT-guided corticosteroid+ bupivicaine and Standard medical care in Disc Herniation and Lumbosacral Radiculopathy, sponsored by Montefiore Medical Center. Terminated at 1 site in United States. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe that it is functionally disabling. The purpose of this randomized clinical trial is to determine if corticosteroid medication, delivered directly to the area near the herniated disc, can improve the pain and functional disability associated with a herniated disc.
478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.
This study's enrollment of 1 is below the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care
Drug: CT-guided corticosteroid+ bupivicaine
Drug: Standard medical care
CT-guided corticosteroid+ bupivicaine Also get standard medical care
Naproxen + Oxycodone/ Acetaminophen
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.
Time frame: Baseline and one week after emergency department discharge
Functional Disability Assessed Using Roland-Morris Scale
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, increasing functional disability.
Time frame: 1 month
Adverse Events
Any adverse events since randomization. %s will be compared between groups
Time frame: 1 week after discharge from emergency department
| Milestone | CT-guided Intervention | Standard Medical Care |
|---|---|---|
| Started | 1 | 0 |
| Completed | 0 | 0 |
| Not completed | 1 | 0 |
| Withdrew: Study terminated. no data collected. | 1 | 0 |
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.
No measurements were reported for this outcome.
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, increasing functional disability.
No measurements were reported for this outcome.
Any adverse events since randomization. %s will be compared between groups
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CT-guided Intervention | — | — | — |
| Standard Medical Care | — | — | — |
No data collected or analyzed because this study was terminated early due to low enrollment.
| Age, Continuous | CT-guided Intervention | Standard Medical Care | Total |
|---|
| Sex: Female, Male | CT-guided Intervention | Standard Medical Care | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race and Ethnicity Not Collected | CT-guided Intervention | Standard Medical Care | Total |
|---|
| Region of Enrollment(participants) | CT-guided Intervention | Standard Medical Care | Total |
|---|
This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Displacement→
Montefiore Medical Center