Trial Outcomes & Findings for CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial (NCT NCT01267825)
NCT ID: NCT01267825
Last Updated: 2018-08-31
Results Overview
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.
TERMINATED
PHASE4
1 participants
Baseline and one week after emergency department discharge
2018-08-31
Participant Flow
Participant milestones
| Measure |
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
|
Standard Medical Care
Standard medical care: Naproxen + Oxycodone/ Acetaminophen
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
Standard Medical Care
Standard medical care: Naproxen + Oxycodone/ Acetaminophen
|
|---|---|---|
|
Overall Study
study terminated. no data collected.
|
1
|
0
|
Baseline Characteristics
CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline and one week after emergency department dischargePopulation: Study terminated due to low enrollment. No patient data was collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthPopulation: Study terminated due to low enrollment. No patient data was collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week after discharge from emergency departmentPopulation: Study terminated due to low enrollment. No patient data was collected.
Any adverse events since randomization. %s will be compared between groups
Outcome measures
Outcome data not reported
Adverse Events
CT-guided Intervention
Standard Medical Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place