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Study terminated early due to low enrollment. No data collected.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-guided intervention | Experimental | CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care |
|
| Standard medical care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-guided corticosteroid+ bupivicaine | Drug | CT-guided corticosteroid+ bupivicaine Also get standard medical care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and one week after emergency department discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Miller, MD | Montefiore Medical Center | Principal Investigator |
| Benjamin W. Friedman, MD, MS | Montefiore Medical Center/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-guided Intervention | CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care CT-guided corticosteroid+ bupivicaine: CT-guided corticosteroid+ bupivicaine Also get standard medical care |
| FG001 | Standard Medical Care | Standard medical care: Naproxen + Oxycodone/ Acetaminophen |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No data collected or analyzed because this study was terminated early due to low enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-guided Intervention | CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care CT-guided corticosteroid+ bupivicaine: CT-guided corticosteroid+ bupivicaine Also get standard medical care |
| BG001 | Standard Medical Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| 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 | 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. | Study terminated due to low enrollment. No patient data was collected. | Posted | Baseline and one week after emergency department discharge |
|
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No data collected or analyzed because this study was terminated early due to low enrollment.
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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 | CT-guided Intervention | CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care CT-guided corticosteroid+ bupivicaine: CT-guided corticosteroid+ bupivicaine Also get standard medical care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin W. Friedman, MD, MS | Montefiore Medical Center | 718-920-6266 | befriedm@montefiore.org |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| Standard medical care | Drug | Naproxen + Oxycodone/ Acetaminophen |
|
| 1 month |
| Adverse Events | Any adverse events since randomization. %s will be compared between groups | 1 week after discharge from emergency department |
Standard medical care: Naproxen + Oxycodone/ Acetaminophen |
| BG002 | Total | Total of all reporting groups |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care
CT-guided corticosteroid+ bupivicaine: CT-guided corticosteroid+ bupivicaine Also get standard medical care
| OG001 | Standard Medical Care | Standard medical care: Naproxen + Oxycodone/ Acetaminophen |
|
| Secondary | 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. | Study terminated due to low enrollment. No patient data was collected. | Posted | 1 month |
|
|
| Secondary | Adverse Events | Any adverse events since randomization. %s will be compared between groups | Study terminated due to low enrollment. No patient data was collected. | Posted | 1 week after discharge from emergency department |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard Medical Care | Standard medical care: Naproxen + Oxycodone/ Acetaminophen | 0 | 0 | 0 | 0 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |