Disc Herniation, Lumbosacral Radiculopathy
Conditions
Keywords
Disc herniation, Lumbosacral radiculopathy, Corticosteroids
Brief summary
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.
Interventions
DRUGCT-guided corticosteroid+ bupivicaine
CT-guided corticosteroid+ bupivicaine Also get standard medical care
DRUGStandard medical care
Naproxen + Oxycodone/ Acetaminophen
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Adults \<60y * \< 1m of symptoms * Symptoms consistent with herniated disc * MRI demonstrates corresponding disc * Back pain resulting in functional disability
Exclusion criteria
* Chronic pain * Daily pain medication * Frequent back pain * On the job injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire | Baseline and one week after emergency department discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Disability Assessed Using Roland-Morris Scale | 1 month | 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. |
| Adverse Events | 1 week after discharge from emergency department | Any adverse events since randomization. %s will be compared between groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 0 |
| Standard Medical Care Standard medical care: Naproxen + Oxycodone/ Acetaminophen | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | study terminated. no data collected. | 1 | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Baseline and one week after emergency department discharge
Population: Study terminated due to low enrollment. No patient data was collected.
Secondary
Adverse Events
Any adverse events since randomization. %s will be compared between groups
Time frame: 1 week after discharge from emergency department
Population: Study terminated due to low enrollment. No patient data was collected.
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.
Time frame: 1 month
Population: Study terminated due to low enrollment. No patient data was collected.