Trial · NCT03389620
Transforaminal Versus Lateralized Interlaminar Cervical Epidurals
NCT03389620, Phase 2, Completed, Duke University; results first posted 2025-12-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Transforaminal Versus Lateralized Interlaminar Cervical Epidurals. Trials, record NCT03389620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03389620
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Transforaminal Versus Lateralized Interlaminar Cervical Epidurals
- NCT number
- NCT03389620
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Cervicogenic Upper Extremity Radiculopathy
- Interventions
- dexamethasone
- First posted
- 2018-01-03
- Last updated
- 2025-12-19
- Results first posted
- 2025-12-19
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Baseline to 2 months | The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain") |
| Secondary | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Baseline, 2 weeks, 4 months | The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain") |
| Secondary | Change in Neck Disability Index (NDI) | Baseline, 2 weeks, 2 months, 4 months | The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability. |
| Secondary | Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) | Baseline, 2 weeks, 2 months, 4 months | EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. It is a well-validated tool for health status measurement, and for health quality-of-life in cervicogenic radicular pain. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labeled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). |
| Secondary | Change in EuroQol-5 Dimension (EQ-5D) Index Score | Baseline, 2 weeks, 2 months, 4 months | EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. It is a well-validated tool for health status measurement, and for health quality-of-life in cervicogenic radicular pain. The index score was derived using the time trade-off (TTO) valuation method and ranges from approximately 0 (dead) to 1 (full health), with negative values indicating health states worse than death. |
| Secondary | Change in Work Ability Index (WAI) Absenteeism | Baseline, 2 weeks, 2 months, 4 months | The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability. |
| Secondary | Change in Work Ability Index (WAI) Presenteeism | Baseline, 2 weeks, 2 months, 4 months | The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability. |
| Secondary | Change in Work Ability Index (WAI) Work Productivity Loss | Baseline, 2 weeks, 2 months, 4 months | The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability. |
| Secondary | Change in Work Ability Index (WAI) Activity Impairment | Baseline, 2 weeks, 2 months, 4 months | The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability. |
| Secondary | Number of Participants With Minor Adverse Events | Immediately post-procedure, 2 days post procedure |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Baseline to 2 months | Data not collected on 3 Transforaminal Cervical Epidural Corticosteroid Injection participants. | score on a scale | MEAN |
| SECONDARY | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Baseline, 2 weeks, 4 months | Participants with data collected at each timepoint. | score on a scale | MEAN |
| SECONDARY | Change in Neck Disability Index (NDI) | Baseline, 2 weeks, 2 months, 4 months | Participants with data collected at each timepoint. | score on a scale | MEAN |
| SECONDARY | Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) | Baseline, 2 weeks, 2 months, 4 months | Participants with data collected at each timepoint. | score on a scale | MEAN |
| SECONDARY | Change in EuroQol-5 Dimension (EQ-5D) Index Score | Baseline, 2 weeks, 2 months, 4 months | Participants with data collected at each timepoint. | score on a scale | MEAN |
| SECONDARY | Change in Work Ability Index (WAI) Absenteeism | Baseline, 2 weeks, 2 months, 4 months | Employed participants with data collected at each timepoint. | score on a scale | MEAN |
| SECONDARY | Change in Work Ability Index (WAI) Presenteeism | Baseline, 2 weeks, 2 months, 4 months | Employed participants with data collected at each timepoint. | score on a scale | MEAN |
| SECONDARY | Change in Work Ability Index (WAI) Work Productivity Loss | Baseline, 2 weeks, 2 months, 4 months | Employed participants with data collected at each timepoint. | score on a scale | MEAN |
| SECONDARY | Change in Work Ability Index (WAI) Activity Impairment | Baseline, 2 weeks, 2 months, 4 months | Employed participants with data collected at each timepoint. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Minor Adverse Events | Immediately post-procedure, 2 days post procedure | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Transforaminal Cervical Epidural Corticosteroid Injections | -3.38 | Standard Deviation 2.50 | score on a scale | |
| Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Lateralized Interlaminar Epidural Corticosteroid Injections | -2.30 | Standard Deviation 2.20 | score on a scale | |
| Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Transforaminal Cervical Epidural Corticosteroid Injections | Baseline to 2 weeks | -2.51 | Standard Deviation 2.58 | score on a scale |
| Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Lateralized Interlaminar Epidural Corticosteroid Injections | Baseline to 2 weeks | -3.03 | Standard Deviation 2.37 | score on a scale |
| Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Transforaminal Cervical Epidural Corticosteroid Injections | Baseline to 4 months | -3.44 | Standard Deviation 3.15 | score on a scale |
| Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Lateralized Interlaminar Epidural Corticosteroid Injections | Baseline to 4 months | -3.31 | Standard Deviation 2.40 | score on a scale |
| Change in Neck Disability Index (NDI) | Transforaminal Cervical Epidural Corticosteroid Injections | Baseline to 2 weeks | -10.97 | Standard Deviation 15.62 | score on a scale |
| Change in Neck Disability Index (NDI) | Lateralized Interlaminar Epidural Corticosteroid Injections | Baseline to 2 weeks | -9.30 | Standard Deviation 12.58 | score on a scale |
| Change in Neck Disability Index (NDI) | Transforaminal Cervical Epidural Corticosteroid Injections | Baseline to 2 months | -10.24 | Standard Deviation 16.03 | score on a scale |
| Change in Neck Disability Index (NDI) | Lateralized Interlaminar Epidural Corticosteroid Injections | Baseline to 2 months | -8.00 | Standard Deviation 16.51 | score on a scale |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Transforaminal Cervical Epidural Corticosteroid Injections | 37 | |
| Overall Study | STARTED | Lateralized Interlaminar Epidural Corticosteroid Injections | 37 | |
| Overall Study | COMPLETED | Transforaminal Cervical Epidural Corticosteroid Injections | 32 | |
| Overall Study | COMPLETED | Lateralized Interlaminar Epidural Corticosteroid Injections | 36 | |
| Overall Study | NOT COMPLETED | Transforaminal Cervical Epidural Corticosteroid Injections | 5 | |
| Overall Study | NOT COMPLETED | Lateralized Interlaminar Epidural Corticosteroid Injections | 1 |
Source ClinicalTrials.gov
Adverse events8
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 | Nausea | Gastrointestinal disorders | Transforaminal Cervical Epidural Corticosteroid Injections | 1 | 37 | |
| other | Nausea | Gastrointestinal disorders | Lateralized Interlaminar Epidural Corticosteroid Injections | 2 | 37 | |
| other | Headache | General disorders | Transforaminal Cervical Epidural Corticosteroid Injections | 3 | 37 | |
| other | Headache | General disorders | Lateralized Interlaminar Epidural Corticosteroid Injections | 4 | 37 | |
| other | Vasovagal | General disorders | Transforaminal Cervical Epidural Corticosteroid Injections | 0 | 37 | |
| other | Vasovagal | General disorders | Lateralized Interlaminar Epidural Corticosteroid Injections | 2 | 37 | |
| other | Lightheadedness | General disorders | Transforaminal Cervical Epidural Corticosteroid Injections | 2 | 37 | |
| other | Lightheadedness | General disorders | Lateralized Interlaminar Epidural Corticosteroid Injections | 2 | 37 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Transforaminal Cervical Epidural Corticosteroid Injections | 0 | 37 |
| Total, all-cause mortality | Lateralized Interlaminar Epidural Corticosteroid Injections | 0 | 37 |
| Total, other adverse events | Transforaminal Cervical Epidural Corticosteroid Injections | 6 | 37 |
| Total, other adverse events | Lateralized Interlaminar Epidural Corticosteroid Injections | 8 | 37 |
| Total, serious adverse events | Transforaminal Cervical Epidural Corticosteroid Injections | 0 | 37 |
| Total, serious adverse events | Lateralized Interlaminar Epidural Corticosteroid Injections | 0 | 37 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections vs Lateralized Interlaminar Epidural Corticosteroid Injections: deaths from any cause | Trial comparisons |
| Transforaminal Cervical Epidural Corticosteroid Injections vs Lateralized Interlaminar Epidural Corticosteroid Injections: serious adverse events | Trial comparisons |
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/NCT03389620
GET https://conductscience.org/api/trials/v1/NCT03389620/results?page=2