Trial · NCT00733096
A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
NCT00733096, Phase 2, Phase 3, Completed, Johns Hopkins University; results first posted 2012-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy. Trials, record NCT00733096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00733096
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
- NCT number
- NCT00733096
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 84 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Lumbosacral Radiculopathy
- Interventions
- etanercept, methylprednisolone, normal saline
- First posted
- 2008-08-12
- Last updated
- 2012-10-08
- Results first posted
- 2012-10-08
- Limitations and caveats
- Subjects who failed to obtain benefit were unblinded after 1-month, which limits conclusions regarding long-term efficacy.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numerical Rating Leg Pain Score | 1 month | 0-10 pain score. 0= no pain, 10= worst imaginable pain. |
| Secondary | Oswestry Disability Score | 1 month | 0-100%. 0= no disability, 100% is complete disability |
| Secondary | Global Perceived Effect | 1 month | Satisfaction. Number of participants with positive perceived global satisfaction. |
| Secondary | Medication Reduction | 1 month | Number of people who reduced medications |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numerical Rating Leg Pain Score | 1 month | Patients who received epidural steroid injections | units on a scale | MEAN |
| SECONDARY | Oswestry Disability Score | 1 month | Patients who received epidural steroid injections | percentage of disability out of 100% | MEAN |
| SECONDARY | Global Perceived Effect | 1 month | Subjects who underwent epidural steroid injections | participants | NUMBER |
| SECONDARY | Medication Reduction | 1 month | Patients who underwent epidural steroid injections | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numerical Rating Leg Pain Score | Steroid | 2.54 | 95% Confidence Interval 1.36 to 3.69 | units on a scale | |
| Numerical Rating Leg Pain Score | Etanercept | 3.56 | 95% Confidence Interval 2.35 to 4.72 | units on a scale | |
| Numerical Rating Leg Pain Score | Saline | 3.78 | 95% Confidence Interval 2.72 to 4.85 | units on a scale | |
| Oswestry Disability Score | Steroid | 22.4 | 95% Confidence Interval 16.64 to 31.55 | percentage of disability out of 100% | |
| Oswestry Disability Score | Etanercept | 40.26 | 95% Confidence Interval 32.91 to 47.61 | percentage of disability out of 100% | |
| Oswestry Disability Score | Saline | 30.00 | 95% Confidence Interval 23.2 to 36.69 | percentage of disability out of 100% | |
| Global Perceived Effect | Steroid | 23 | participants | ||
| Global Perceived Effect | Etanercept | 15 | participants | ||
| Global Perceived Effect | Saline | 17 | participants | ||
| Medication Reduction | Steroid | 17 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Steroid | 28 | |
| Overall Study | STARTED | Etanercept | 26 | |
| Overall Study | STARTED | Saline | 30 | |
| Overall Study | COMPLETED | Steroid | 28 | |
| Overall Study | COMPLETED | Etanercept | 26 | |
| Overall Study | COMPLETED | Saline | 30 | |
| Overall Study | NOT COMPLETED | Steroid | 0 | |
| Overall Study | NOT COMPLETED | Etanercept | 0 | |
| Overall Study | NOT COMPLETED | Saline | 0 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Worsening pain | General disorders | Steroid | 0 | 28 | |
| other | Worsening pain | General disorders | Etanercept | 4 | 26 | |
| other | Worsening pain | General disorders | Saline | 3 | 30 | |
| other | Nonlocal infection | Infections and infestations | Steroid | 0 | 28 | |
| other | Nonlocal infection | Infections and infestations | Etanercept | 1 | 26 | |
| other | Nonlocal infection | Infections and infestations | Saline | 3 | 30 | |
| other | Nonlocal rash | Infections and infestations | Steroid | 1 | 28 | |
| other | Nonlocal rash | Infections and infestations | Etanercept | 0 | 26 | |
| other | Nonlocal rash | Infections and infestations | Saline | 0 | 30 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Steroid | ||
| Total, all-cause mortality | Etanercept | ||
| Total, all-cause mortality | Saline | ||
| Total, other adverse events | Steroid | 1 | 28 |
| Total, other adverse events | Etanercept | 5 | 26 |
| Total, other adverse events | Saline | 6 | 30 |
| Total, serious adverse events | Steroid | 0 | 28 |
| Total, serious adverse events | Etanercept | 0 | 26 |
| Total, serious adverse events | Saline | 0 | 30 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00733096
GET https://conductscience.org/api/trials/v1/NCT00733096/registered