Cervicogenic Upper Extremity Radiculopathy
Conditions
Keywords
CT-fluoroscopy, Corticosteroid injection
Brief summary
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.
Interventions
DRUGdexamethasone
0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain) * Baseline numerical pain scale (NRS) score \> 4
Exclusion criteria
* Recent (i.e., \< 2 months) cervical spine surgery * Recent (i.e., \< 1 month) cervical epidural or upper extremity corticosteroid injection * Contraindication or inability to the undergo procedure * Inability to provide informed consent * Expected inability to complete follow-up assessment * Contraindication to receiving contrast material (precluding an epidurogram)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 | — |
| 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) |
Other
| Measure | 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 |
Countries
United States
Participant flow
Recruitment details
Patients with unilateral cervicogenic radiculopathy referred for a cervical epidural steroid injection were recruited from the outpatient Duke Radiology Spine Intervention Clinic.
Pre-assignment details
This is not a crossover study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 37 |
| 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 | 37 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 1 |
Baseline characteristics
| Characteristic | Transforaminal Cervical Epidural Corticosteroid Injections | Total | Lateralized Interlaminar Epidural Corticosteroid Injections |
|---|---|---|---|
| Age, Continuous | 56.68 years STANDARD_DEVIATION 14.11 | 55.58 years STANDARD_DEVIATION 13.03 | 54.49 years STANDARD_DEVIATION 11.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 71 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 54 Participants | 29 Participants |
| Region of Enrollment United States | 37 Participants | 74 Participants | 37 Participants |
| Sex: Female, Male Female | 22 Participants | 43 Participants | 21 Participants |
| Sex: Female, Male Male | 15 Participants | 31 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 6 / 37 | 8 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
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)
Time frame: Baseline to 2 months
Population: Data not collected on 3 Transforaminal Cervical Epidural Corticosteroid Injection participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | -3.38 score on a scale | Standard Deviation 2.5 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | -2.30 score on a scale | Standard Deviation 2.2 |
p-value: 0.057t-test, 1 sided
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.
Time frame: Baseline, 2 weeks, 2 months, 4 months
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Index Score | Baseline to 2 weeks | 0.085 score on a scale | Standard Deviation 0.238 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Index Score | Baseline to 2 months | 0.088 score on a scale | Standard Deviation 0.205 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Index Score | Baseline to 4 months | 0.145 score on a scale | Standard Deviation 0.257 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Index Score | Baseline to 2 weeks | 0.137 score on a scale | Standard Deviation 0.202 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Index Score | Baseline to 2 months | 0.131 score on a scale | Standard Deviation 0.205 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Index Score | Baseline to 4 months | 0.172 score on a scale | Standard Deviation 0.259 |
Comparison: Baseline to 2 weeksp-value: 0.311t-test, 2 sided
Comparison: Baseline to 2 monthsp-value: 0.377t-test, 2 sided
Comparison: Baseline to 4 monthsp-value: 0.668t-test, 2 sided
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).
Time frame: Baseline, 2 weeks, 2 months, 4 months
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) | Baseline to 2 weeks | 5.49 score on a scale | Standard Deviation 25.4 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) | Baseline to 2 months | 3.79 score on a scale | Standard Deviation 23.58 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) | Baseline to 4 months | 1.48 score on a scale | Standard Deviation 37.45 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) | Baseline to 2 weeks | -0.38 score on a scale | Standard Deviation 21.51 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) | Baseline to 2 months | -1.03 score on a scale | Standard Deviation 20.69 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) | Baseline to 4 months | 2.69 score on a scale | Standard Deviation 18.15 |
Comparison: Baseline to 2 weeksp-value: 0.287t-test, 2 sided
Comparison: Baseline to 2 monthsp-value: 0.365t-test, 2 sided
Comparison: Baseline to 4 monthsp-value: 0.867t-test, 2 sided
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.
Time frame: Baseline, 2 weeks, 2 months, 4 months
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Neck Disability Index (NDI) | Baseline to 2 weeks | -10.97 score on a scale | Standard Deviation 15.62 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Neck Disability Index (NDI) | Baseline to 2 months | -10.24 score on a scale | Standard Deviation 16.03 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Neck Disability Index (NDI) | Baseline to 4 months | -14.25 score on a scale | Standard Deviation 22.04 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Neck Disability Index (NDI) | Baseline to 2 weeks | -9.30 score on a scale | Standard Deviation 12.58 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Neck Disability Index (NDI) | Baseline to 2 months | -8.00 score on a scale | Standard Deviation 16.51 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Neck Disability Index (NDI) | Baseline to 4 months | -14.00 score on a scale | Standard Deviation 16.18 |
Comparison: Baseline to 2 weeksp-value: 0.613t-test, 2 sided
Comparison: Baseline to 2 monthsp-value: 0.565t-test, 2 sided
Comparison: Baseline to 4 monthsp-value: 0.958t-test, 2 sided
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)
Time frame: Baseline, 2 weeks, 4 months
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Baseline to 2 weeks | -2.51 score on a scale | Standard Deviation 2.58 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Baseline to 4 months | -3.44 score on a scale | Standard Deviation 3.15 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Baseline to 2 weeks | -3.03 score on a scale | Standard Deviation 2.37 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) | Baseline to 4 months | -3.31 score on a scale | Standard Deviation 2.4 |
Comparison: Baseline to 2 weeksp-value: 0.376t-test, 2 sided
Comparison: Baseline to 4 monthsp-value: 0.848t-test, 2 sided
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.
Time frame: Baseline, 2 weeks, 2 months, 4 months
Population: Employed participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Absenteeism | Baseline to 2 weeks | -11.76 score on a scale | Standard Deviation 31.82 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Absenteeism | Baseline to 2 months | -13.66 score on a scale | Standard Deviation 30.09 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Absenteeism | Baseline to 4 months | -9.09 score on a scale | Standard Deviation 25.09 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Absenteeism | Baseline to 2 weeks | -8.81 score on a scale | Standard Deviation 35.85 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Absenteeism | Baseline to 2 months | -11.40 score on a scale | Standard Deviation 38.96 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Absenteeism | Baseline to 4 months | -12.37 score on a scale | Standard Deviation 27.28 |
Comparison: Baseline to 2 weeksp-value: 0.794t-test, 2 sided
Comparison: Baseline to 2 monthsp-value: 0.843t-test, 2 sided
Comparison: Baseline to 4 monthsp-value: 0.713t-test, 2 sided
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.
Time frame: Baseline, 2 weeks, 2 months, 4 months
Population: Employed participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Activity Impairment | Baseline to 2 weeks | -13.51 score on a scale | Standard Deviation 31.2 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Activity Impairment | Baseline to 2 months | -9.12 score on a scale | Standard Deviation 32.13 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Activity Impairment | Baseline to 4 months | -18.18 score on a scale | Standard Deviation 32.74 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Activity Impairment | Baseline to 2 weeks | -12.70 score on a scale | Standard Deviation 25.35 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Activity Impairment | Baseline to 2 months | -14.32 score on a scale | Standard Deviation 32.54 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Activity Impairment | Baseline to 4 months | -21.11 score on a scale | Standard Deviation 33.87 |
Comparison: Baseline to 2 weeksp-value: 0.903t-test, 2 sided
Comparison: Baseline to 2 monthsp-value: 0.5t-test, 2 sided
Comparison: Baseline to 4 monthsp-value: 0.716t-test, 2 sided
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.
Time frame: Baseline, 2 weeks, 2 months, 4 months
Population: Employed participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Presenteeism | Baseline to 2 weeks | -8.95 score on a scale | Standard Deviation 21.58 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Presenteeism | Baseline to 2 months | -8.95 score on a scale | Standard Deviation 22.58 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Presenteeism | Baseline to 4 months | -26.50 score on a scale | Standard Deviation 43.44 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Presenteeism | Baseline to 2 weeks | -19.55 score on a scale | Standard Deviation 27.68 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Presenteeism | Baseline to 2 months | -19.09 score on a scale | Standard Deviation 40.93 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Presenteeism | Baseline to 4 months | -18.82 score on a scale | Standard Deviation 24.46 |
Comparison: Baseline to 2 weeksp-value: 0.177t-test, 2 sided
Comparison: Baseline to 2 monthsp-value: 0.325t-test, 2 sided
Comparison: Baseline to 4 monthsp-value: 0.505t-test, 2 sided
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.
Time frame: Baseline, 2 weeks, 2 months, 4 months
Population: Employed participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Work Productivity Loss | Baseline to 2 weeks | -18.97 score on a scale | Standard Deviation 18.8 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Work Productivity Loss | Baseline to 2 months | -8.95 score on a scale | Standard Deviation 22.58 |
| Transforaminal Cervical Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Work Productivity Loss | Baseline to 4 months | -21.16 score on a scale | Standard Deviation 25.84 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Work Productivity Loss | Baseline to 2 weeks | -20.79 score on a scale | Standard Deviation 34.32 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Work Productivity Loss | Baseline to 2 months | -19.09 score on a scale | Standard Deviation 40.93 |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Change in Work Ability Index (WAI) Work Productivity Loss | Baseline to 4 months | -26.37 score on a scale | Standard Deviation 45.47 |
Comparison: Baseline to 2 weeksp-value: 0.811t-test, 2 sided
Comparison: Baseline to 2 monthsp-value: 0.325t-test, 2 sided
Comparison: Baseline to 4 monthsp-value: 0.674t-test, 2 sided
Secondary
Number of Participants With Major Adverse Events
Time frame: Immediately post-procedure, 2 days post procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Number of Participants With Major Adverse Events | Immediately post-procedure | 0 Participants |
| Transforaminal Cervical Epidural Corticosteroid Injections | Number of Participants With Major Adverse Events | 2 days post procedure | 0 Participants |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Number of Participants With Major Adverse Events | Immediately post-procedure | 0 Participants |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Number of Participants With Major Adverse Events | 2 days post procedure | 0 Participants |
Secondary
Number of Participants With Minor Adverse Events
Time frame: Immediately post-procedure, 2 days post procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Number of Participants With Minor Adverse Events | Immediately post-procedure | 3 Participants |
| Transforaminal Cervical Epidural Corticosteroid Injections | Number of Participants With Minor Adverse Events | 2 days post procedure | 4 Participants |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Number of Participants With Minor Adverse Events | Immediately post-procedure | 6 Participants |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Number of Participants With Minor Adverse Events | 2 days post procedure | 5 Participants |
Comparison: Immediately post-procedurep-value: 0.461Fisher Exact
Comparison: 2 days post procedurep-value: 1Fisher Exact
Other Pre-specified
Number of Participants With Contrast Spread Into the Medial Half of the Neuroforamen
Time frame: During procedure
Other Pre-specified
Number of Participants With Inadvertent Intravascular Contrast Injections
Time frame: During procedure