Cervicogenic Upper Extremity RadiculopathyPhase 2NCT03389620
Transforaminal Versus Lateralized Interlaminar Cervical Epidurals
A Phase 2 study testing dexamethasone in people with Cervicogenic Upper Extremity Radiculopathy, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervicogenic Upper Extremity Radiculopathy
- What is being tested?
- dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2018to 16 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain)
- Baseline numerical pain scale (NRS) score > 4
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Radiology and Orthopaedic Clinic
Durham, North Carolina, 27710
About this study
Official title: Comparison of Cervical Transforaminal Epidural Corticosteroid Injections With Lateralized Interlaminar Epidural Corticosteroid Injections for Treatment of Cervicogenic Upper Extremity Radiculopathy
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.
- Being tested
- dexamethasone
- Keywords
- CT-fluoroscopy, Corticosteroid injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Active comparator | Not described Receives: Drug: dexamethasone |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Experimental | Not described Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: Baseline to 2 months
Secondary outcomes (10)
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")
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 weeks, 2 months, 4 months
Number of Participants With Minor Adverse Events
Measured: Immediately post-procedure, 2 days post procedure
Number of Participants With Major Adverse Events
Measured: Immediately post-procedure, 2 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start5 Jan 2018
- Primary completion16 Jul 2023
- Study completion16 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervicogenic Upper Extremity RadiculopathyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Amrhein, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389620
- Sponsor's protocol ID
- Pro00083262
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2017
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cervical Transforaminal Epidural Corticosteroid Injections With Lateralized Interlaminar Epidural Corticosteroid Injections for Treatment of Cervicogenic Upper Extremity Radiculopathy
- ClinicalTrials.gov ID
- NCT03389620
- Acronym / sponsor ID
- Pro00083262
- Keywords
- CT-fluoroscopy, Corticosteroid injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 16 Jul 2023 (actual)
- Study completion
- 16 Sep 2023 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transforaminal Cervical Epidural Corticosteroid Injections | Active comparator | Drug: dexamethasone |
| Lateralized Interlaminar Epidural Corticosteroid Injections | Experimental | Drug: dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain)
- Baseline numerical pain scale (NRS) score > 4
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds | Drug | Lateralized Interlaminar Epidural Corticosteroid Injections, Transforaminal Cervical Epidural Corticosteroid Injections |
Primary outcome
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")
10 secondary outcomes
Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)
Time frame: Baseline, 2 weeks, 4 months
Change in Neck Disability Index (NDI)
Time frame: Baseline, 2 weeks, 2 months, 4 months
Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS)
Time frame: Baseline, 2 weeks, 2 months, 4 months
Change in EuroQol-5 Dimension (EQ-5D) Index Score
Time frame: Baseline, 2 weeks, 2 months, 4 months
Change in Work Ability Index (WAI) Absenteeism
Time frame: Baseline, 2 weeks, 2 months, 4 months
Change in Work Ability Index (WAI) Presenteeism
Time frame: Baseline, 2 weeks, 2 months, 4 months
Change in Work Ability Index (WAI) Work Productivity Loss
Time frame: Baseline, 2 weeks, 2 months, 4 months
Change in Work Ability Index (WAI) Activity Impairment
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Amrhein, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexamethasone in people with Cervicogenic Upper Extremity Radiculopathy, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) (time frame: Baseline to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.