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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
74
0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Duke Radiology and Orthopaedic Clinic
Durham, North Carolina, United States
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
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
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
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
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2 weeks, 2 months, 4 months
Number of Participants With Minor Adverse Events
Time frame: Immediately post-procedure, 2 days post procedure
Number of Participants With Major Adverse Events
Time frame: Immediately post-procedure, 2 days post procedure