Trial Outcomes & Findings for Transforaminal Versus Lateralized Interlaminar Cervical Epidurals (NCT NCT03389620)

NCT ID: NCT03389620

Last Updated: 2025-12-19

Results Overview

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")

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 74 participants
• Primary outcome timeframe: Baseline to 2 months
• Results posted on: 2025-12-19

Participant Flow

Patients with unilateral cervicogenic radiculopathy referred for a cervical epidural steroid injection were recruited from the outpatient Duke Radiology Spine Intervention Clinic.

This is not a crossover study.

Participant milestones

Measure	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	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
Overall Study STARTED	37	37
Overall Study COMPLETED	32	36
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	5	1

Baseline Characteristics

Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

Baseline characteristics by cohort

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Total n=74 Participants Total of all reporting groups
Age, Continuous	56.68 years STANDARD_DEVIATION 14.11 • n=8 Participants	54.49 years STANDARD_DEVIATION 11.94 • n=6 Participants	55.58 years STANDARD_DEVIATION 13.03 • n=6 Participants
Sex: Female, Male Female	22 Participants n=8 Participants	21 Participants n=6 Participants	43 Participants n=6 Participants
Sex: Female, Male Male	15 Participants n=8 Participants	16 Participants n=6 Participants	31 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=8 Participants	36 Participants n=6 Participants	71 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=8 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Black or African American	9 Participants n=8 Participants	8 Participants n=6 Participants	17 Participants n=6 Participants
Race (NIH/OMB) White	25 Participants n=8 Participants	29 Participants n=6 Participants	54 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
Region of Enrollment United States	37 Participants n=8 Participants	37 Participants n=6 Participants	74 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline to 2 months

Population: Data not collected on 3 Transforaminal Cervical Epidural Corticosteroid Injection participants.

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")

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=34 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)	-3.38 score on a scale Standard Deviation 2.50	-2.30 score on a scale Standard Deviation 2.20

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 months

Population: Participants with data collected at each timepoint.

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")

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
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	-3.03 score on a scale Standard Deviation 2.37
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	-3.31 score on a scale Standard Deviation 2.40

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 2 months, 4 months

Population: Participants with data collected at each timepoint.

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.

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Change in Neck Disability Index (NDI) Baseline to 2 weeks	-10.97 score on a scale Standard Deviation 15.62	-9.30 score on a scale Standard Deviation 12.58
Change in Neck Disability Index (NDI) Baseline to 2 months	-10.24 score on a scale Standard Deviation 16.03	-8.00 score on a scale Standard Deviation 16.51
Change in Neck Disability Index (NDI) Baseline to 4 months	-14.25 score on a scale Standard Deviation 22.04	-14.00 score on a scale Standard Deviation 16.18

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 2 months, 4 months

Population: Participants with data collected at each timepoint.

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).

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS) Baseline to 2 weeks	5.49 score on a scale Standard Deviation 25.40	-0.38 score on a scale Standard Deviation 21.51
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	-1.03 score on a scale Standard Deviation 20.69
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	2.69 score on a scale Standard Deviation 18.15

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 2 months, 4 months

Population: Participants with data collected at each timepoint.

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.

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Change in EuroQol-5 Dimension (EQ-5D) Index Score Baseline to 2 weeks	0.085 score on a scale Standard Deviation 0.238	0.137 score on a scale Standard Deviation 0.202
Change in EuroQol-5 Dimension (EQ-5D) Index Score Baseline to 2 months	0.088 score on a scale Standard Deviation 0.205	0.131 score on a scale Standard Deviation 0.205
Change in EuroQol-5 Dimension (EQ-5D) Index Score Baseline to 4 months	0.145 score on a scale Standard Deviation 0.257	0.172 score on a scale Standard Deviation 0.259

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 2 months, 4 months

Population: Employed participants with data collected at each timepoint.

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.

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=20 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=22 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Change in Work Ability Index (WAI) Absenteeism Baseline to 2 weeks	-11.76 score on a scale Standard Deviation 31.82	-8.81 score on a scale Standard Deviation 35.85
Change in Work Ability Index (WAI) Absenteeism Baseline to 2 months	-13.66 score on a scale Standard Deviation 30.09	-11.40 score on a scale Standard Deviation 38.96
Change in Work Ability Index (WAI) Absenteeism Baseline to 4 months	-9.09 score on a scale Standard Deviation 25.09	-12.37 score on a scale Standard Deviation 27.28

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 2 months, 4 months

Population: Employed participants with data collected at each timepoint.

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.

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=21 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=22 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Change in Work Ability Index (WAI) Presenteeism Baseline to 2 weeks	-8.95 score on a scale Standard Deviation 21.58	-19.55 score on a scale Standard Deviation 27.68
Change in Work Ability Index (WAI) Presenteeism Baseline to 2 months	-8.95 score on a scale Standard Deviation 22.58	-19.09 score on a scale Standard Deviation 40.93
Change in Work Ability Index (WAI) Presenteeism Baseline to 4 months	-26.50 score on a scale Standard Deviation 43.44	-18.82 score on a scale Standard Deviation 24.46

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 2 months, 4 months

Population: Employed participants with data collected at each timepoint.

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.

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=20 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=22 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Change in Work Ability Index (WAI) Work Productivity Loss Baseline to 2 months	-8.95 score on a scale Standard Deviation 22.58	-19.09 score on a scale Standard Deviation 40.93
Change in Work Ability Index (WAI) Work Productivity Loss Baseline to 4 months	-21.16 score on a scale Standard Deviation 25.84	-26.37 score on a scale Standard Deviation 45.47
Change in Work Ability Index (WAI) Work Productivity Loss Baseline to 2 weeks	-18.97 score on a scale Standard Deviation 18.80	-20.79 score on a scale Standard Deviation 34.32

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 2 months, 4 months

Population: Employed participants with data collected at each timepoint.

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.

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=20 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=22 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Change in Work Ability Index (WAI) Activity Impairment Baseline to 2 weeks	-13.51 score on a scale Standard Deviation 31.20	-12.70 score on a scale Standard Deviation 25.35
Change in Work Ability Index (WAI) Activity Impairment Baseline to 2 months	-9.12 score on a scale Standard Deviation 32.13	-14.32 score on a scale Standard Deviation 32.54
Change in Work Ability Index (WAI) Activity Impairment Baseline to 4 months	-18.18 score on a scale Standard Deviation 32.74	-21.11 score on a scale Standard Deviation 33.87

SECONDARY outcome

Timeframe: Immediately post-procedure, 2 days post procedure

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Number of Participants With Minor Adverse Events Immediately post-procedure	3 Participants	6 Participants
Number of Participants With Minor Adverse Events 2 days post procedure	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Immediately post-procedure, 2 days post procedure

Outcome measures

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=37 Participants dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Number of Participants With Major Adverse Events Immediately post-procedure	0 Participants	0 Participants
Number of Participants With Major Adverse Events 2 days post procedure	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During procedure

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: During procedure

Outcome measures

Outcome data not reported

Adverse Events

Transforaminal Cervical Epidural Corticosteroid Injections

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Lateralized Interlaminar Epidural Corticosteroid Injections

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Transforaminal Cervical Epidural Corticosteroid Injections n=37 participants at risk dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds	Lateralized Interlaminar Epidural Corticosteroid Injections n=37 participants at risk dexamethasone: 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Gastrointestinal disorders Nausea	2.7% 1/37 • Up to 2 days post-procedure	5.4% 2/37 • Up to 2 days post-procedure
General disorders Headache	8.1% 3/37 • Up to 2 days post-procedure	10.8% 4/37 • Up to 2 days post-procedure
General disorders Vasovagal	0.00% 0/37 • Up to 2 days post-procedure	5.4% 2/37 • Up to 2 days post-procedure
General disorders Lightheadedness	5.4% 2/37 • Up to 2 days post-procedure	5.4% 2/37 • Up to 2 days post-procedure

Additional Information

Timothy J. Amrhein, M.D.

Duke University

Phone: 919-684-1909

Email: timothy.amrhein@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place