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The purpose of this study is to compare two methods of giving epidural steroid injections for nerve pain in the arm that comes from the neck. An epidural steroid injection can be given in two different ways, either in the back of the spine within the neck or in the neck next to the nerve root going to the arm. Both are standard medical treatments. The investigators would like to see how effective these treatments are, and if there are any differences in effectiveness or safety between these two routes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Active Comparator |
| |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone | Drug | 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | 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") | Baseline to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | 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") | Baseline, 2 weeks, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Inadvertent Intravascular Contrast Injections | During procedure | |
| Number of Participants With Contrast Spread Into the Medial Half of the Neuroforamen | During procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Amrhein, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Radiology and Orthopaedic Clinic | Durham | North Carolina | 27710 | United States |
This is not a crossover study.
Patients with unilateral cervicogenic radiculopathy referred for a cervical epidural steroid injection were recruited from the outpatient Duke Radiology Spine Intervention Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transforaminal Cervical Epidural Corticosteroid Injections | dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds |
| FG001 | Lateralized Interlaminar Epidural Corticosteroid Injections | dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transforaminal Cervical Epidural Corticosteroid Injections | dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds |
| BG001 | Lateralized Interlaminar Epidural Corticosteroid Injections |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | 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") | Data not collected on 3 Transforaminal Cervical Epidural Corticosteroid Injection participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 2 months |
|
Up to 2 days post-procedure
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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 | Transforaminal Cervical Epidural Corticosteroid Injections | dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy J. Amrhein, M.D. | Duke University | 919-684-1909 | timothy.amrhein@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2022 | Jul 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Change in Neck Disability Index (NDI) |
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. |
| Baseline, 2 weeks, 2 months, 4 months |
| Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) | 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). | Baseline, 2 weeks, 2 months, 4 months |
| Change in EuroQol-5 Dimension (EQ-5D) Index Score | 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. | Baseline, 2 weeks, 2 months, 4 months |
| Change in Work Ability Index (WAI) Absenteeism | 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. | Baseline, 2 weeks, 2 months, 4 months |
| Change in Work Ability Index (WAI) Presenteeism | 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. | Baseline, 2 weeks, 2 months, 4 months |
| Change in Work Ability Index (WAI) Work Productivity Loss | 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. | Baseline, 2 weeks, 2 months, 4 months |
| Change in Work Ability Index (WAI) Activity Impairment | 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. | Baseline, 2 weeks, 2 months, 4 months |
| Number of Participants With Minor Adverse Events | Immediately post-procedure, 2 days post procedure |
| Number of Participants With Major Adverse Events | Immediately post-procedure, 2 days post procedure |
dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds |
|
|
|
| Secondary | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | 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") | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 4 months |
|
|
|
|
| Secondary | Change in Neck Disability Index (NDI) | 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. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 2 months, 4 months |
|
|
|
|
| Secondary | Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) | 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). | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 2 months, 4 months |
|
|
|
|
| Secondary | Change in EuroQol-5 Dimension (EQ-5D) Index Score | 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. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 2 months, 4 months |
|
|
|
|
| Secondary | Change in Work Ability Index (WAI) Absenteeism | 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. | Employed participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 2 months, 4 months |
|
|
|
|
| Secondary | Change in Work Ability Index (WAI) Presenteeism | 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. | Employed participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 2 months, 4 months |
|
|
|
|
| Secondary | Change in Work Ability Index (WAI) Work Productivity Loss | 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. | Employed participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 2 months, 4 months |
|
|
|
|
| Secondary | Change in Work Ability Index (WAI) Activity Impairment | 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. | Employed participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 2 months, 4 months |
|
|
|
|
| Secondary | Number of Participants With Minor Adverse Events | Posted | Count of Participants | Participants | Immediately post-procedure, 2 days post procedure |
|
|
|
|
| Secondary | Number of Participants With Major Adverse Events | Posted | Count of Participants | Participants | Immediately post-procedure, 2 days post procedure |
|
|
|
| Other Pre-specified | Number of Participants With Inadvertent Intravascular Contrast Injections | Not Posted | During procedure | Participants |
| Other Pre-specified | Number of Participants With Contrast Spread Into the Medial Half of the Neuroforamen | Not Posted | During procedure | Participants |
| 0 |
| 37 |
| 0 |
| 37 |
| 6 |
| 37 |
| EG001 | Lateralized Interlaminar Epidural Corticosteroid Injections | dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds | 0 | 37 | 0 | 37 | 8 | 37 |
| Headache | General disorders | Systematic Assessment |
|
| Vasovagal | General disorders | Systematic Assessment |
|
| Lightheadedness | General disorders | Systematic Assessment |
|
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Baseline to 4 months |
|
|
| 0.848 |
| Superiority |
| Baseline to 2 months |
|
|
| Baseline to 4 months |
|
|
| 0.565 |
| Superiority |
| Baseline to 4 months | t-test, 2 sided | 0.958 | Superiority |
| Baseline to 2 months |
|
|
| Baseline to 4 months |
|
|
| 0.365 |
| Superiority |
| Baseline to 4 months | t-test, 2 sided | 0.867 | Superiority |
| Baseline to 2 months |
|
|
| Baseline to 4 months |
|
|
| 0.377 |
| Superiority |
| Baseline to 4 months | t-test, 2 sided | 0.668 | Superiority |
| Baseline to 2 months |
|
|
| Baseline to 4 months |
|
|
| 0.843 |
| Superiority |
| Baseline to 4 months | t-test, 2 sided | 0.713 | Superiority |
| Baseline to 2 months |
|
|
| Baseline to 4 months |
|
|
| 0.325 |
| Superiority |
| Baseline to 4 months | t-test, 2 sided | 0.505 | Superiority |
| Baseline to 2 months |
|
|
| Baseline to 4 months |
|
|
| 0.325 |
| Superiority |
| Baseline to 4 months | t-test, 2 sided | 0.674 | Superiority |
| Baseline to 2 months |
|
|
| Baseline to 4 months |
|
|
| 0.500 |
| Superiority |
| Baseline to 4 months | t-test, 2 sided | 0.716 | Superiority |
| 1.00 |
| Superiority |