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OpenTrials
Completed

NCT Number: NCT03389620

Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

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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Key information

Conditions

Cervicogenic Upper Extremity Radiculopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke Radiology and Orthopaedic Clinic

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexamethasone

Drug

0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds

Primary outcomes

  1. Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)

    Time frame: 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 outcomes

  1. Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)

    Time frame: 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")

  2. Change in Neck Disability Index (NDI)

    Time frame: 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.

  3. Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS)

    Time frame: 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).

  4. Change in EuroQol-5 Dimension (EQ-5D) Index Score

    Time frame: 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.

  5. Change in Work Ability Index (WAI) Absenteeism

    Time frame: 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.

  6. Change in Work Ability Index (WAI) Presenteeism

    Time frame: 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.

  7. Change in Work Ability Index (WAI) Work Productivity Loss

    Time frame: 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.

  8. Change in Work Ability Index (WAI) Activity Impairment

    Time frame: 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.

  9. Number of Participants With Minor Adverse Events

    Time frame: Immediately post-procedure, 2 days post procedure

  10. Number of Participants With Major Adverse Events

    Time frame: Immediately post-procedure, 2 days post procedure

Other outcomes

  1. Number of Participants With Inadvertent Intravascular Contrast Injections

    Time frame: During procedure

  2. Number of Participants With Contrast Spread Into the Medial Half of the Neuroforamen

    Time frame: During procedure

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Comparison of Cervical Transforaminal Epidural Corticosteroid Injections With Lateralized Interlaminar Epidural Corticosteroid Injections for Treatment of Cervicogenic Upper Extremity Radiculopathy

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2018
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.