Cervical RadiculopathyPhase 4NCT03165825
Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection
A Phase 4 study testing Transforaminal Epidural Steroid Injection with Dexamethasone and Interlaminar Epidural Steroid Injection with Betamethasone in people with Cervical Radiculopathy, run by Vanderbilt University Medical Center.
Trial summary
compare cervical interlaminar epidural injection of betamethasone (9mg) and cervical transforaminal epidural injection of dexamethasone (15 mg) for cervical radicular pain Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Transforaminal Epidural Steroid Injection with Dexamethasone and Interlaminar Epidural Steroid Injection with Betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Oct 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - aged >18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
- unilateral cervical radicular pain as defined by arm pain or shoulder girdle pain/periscapular pain with or without neck pain of at least 2 weeks.
- 7 day average of numeric pain rating score (NPRS) for arm pain or shoulder girdle/periscapular pain of at least 5/10 at baseline evaluation
- MRI (or CT if MRI not available) shows one or two level cervical disc herniation(s) or disc osteophyte complex(es) between levels C4-T1, corresponding in location with unilateral radicular pain, with or without neurological deficits. MRI or CT may show degenerative changes at other levels.
- Patient consents to treatment with epidural injection in a shared decision-making process with the treating physician.
- Pain duration of at least 2 weeks or more.
Who cannot join
- - Neck pain is greater than arm pain or shoulder girdle/periscapular pain based on 7 day average NPRS
- Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
- Those involved in active litigation relevant to their pain.
- Those unable to read English and complete the assessment instruments.
- Those unable to attend follow up appointments
- The patient is incarcerated.
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- Spondylolisthesis at the involved or adjacent segments.
- History of prior cervical surgery
- Progressive motor deficit, and/or clinical signs of myelopathy.
- Prior cervical epidural steroid injections.
- Prior epidural steroid injection within the prior 12 months in any location within the spine.
- Possible pregnancy or other reason that precludes the use of fluoroscopy.
- Allergy to contrast media or local anesthetics.
- BMI>35.
- Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
- Active infection or treatment of infection with antibiotics within the past 7 days.
- Medical conditions causing significant functional disability (e.g., stroke, COPD)
- Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
- Addictive behavior, severe clinical depression, or psychotic features.
About this study
Official title: Pragmatic Randomized Prospective Study of Cervical Interlaminar Epidural Injection of Particulate Steroid and Cervical Transforaminal Epidural Injection of Non-particulate Steroid in Patients With Cervical Radicular Pain
compare cervical interlaminar epidural injection of betamethasone (9mg) and cervical transforaminal epidural injection of dexamethasone (15 mg) for cervical radicular pain
Read the detailed description
This study will compare one route of epidural steroid injection (interlaminar) using a particulate steroid to another route of epidural steroid injection (transforaminal) using a different non-particulate steroid dexamethasone. Repeat injections may be allowed.
All injections will be done with image guidance. Patients will be evaluated for improvements in pain and function.
- Conditions
- Cervical Radiculopathy
- Being tested
- Transforaminal Epidural Steroid Injection with Dexamethasone, Interlaminar Epidural Steroid Injection with Betamethasone
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Epidural Steroid Injection with DexamethasoneDrug
Also called Decadron
Transforaminal Epidural Steroid Injection with Dexamethasone
Interlaminar Epidural Steroid Injection with BetamethasoneDrug
Interlaminar Epidural Steroid Injection with Betamethasone
| Study group | Role | What they receive |
|---|---|---|
| Tranforaminal | Experimental | will receive cervical epidural injection via a transforaminal route with dexamethasone steroid Receives: Drug: Transforaminal Epidural Steroid Injection with Dexamethasone |
| Interlaminar | Active comparator | will receive cervical epidural injection via an interlaminar route with betamethasone steroid Receives: Drug: Interlaminar Epidural Steroid Injection with Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Numeric rating pain score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study startJan 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byron Schneider, Vanderbilt University Medical Center
- Investigators
- Byron Schneider, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165825
- Sponsor's protocol ID
- IRB #170187
- Status last verified
- Oct 2018
- First submitted
- 16 May 2017
- Last updated
- 4 Oct 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Prospective Study of Cervical Interlaminar Epidural Injection of Particulate Steroid and Cervical Transforaminal Epidural Injection of Non-particulate Steroid in Patients With Cervical Radicular Pain
- ClinicalTrials.gov ID
- NCT03165825
- Acronym / sponsor ID
- IRB #170187
- Conditions
- Cervical Radiculopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
compare cervical interlaminar epidural injection of betamethasone (9mg) and cervical transforaminal epidural injection of dexamethasone (15 mg) for cervical radicular pain
Detailed description
This study will compare one route of epidural steroid injection (interlaminar) using a particulate steroid to another route of epidural steroid injection (transforaminal) using a different non-particulate steroid dexamethasone. Repeat injections may be allowed.
All injections will be done with image guidance. Patients will be evaluated for improvements in pain and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranforaminal | Experimental | Drug: Transforaminal Epidural Steroid Injection with Dexamethasonewill receive cervical epidural injection via a transforaminal route with dexamethasone steroid |
| Interlaminar | Active comparator | Drug: Interlaminar Epidural Steroid Injection with Betamethasonewill receive cervical epidural injection via an interlaminar route with betamethasone steroid |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - aged >18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
- unilateral cervical radicular pain as defined by arm pain or shoulder girdle pain/periscapular pain with or without neck pain of at least 2 weeks.
- 7 day average of numeric pain rating score (NPRS) for arm pain or shoulder girdle/periscapular pain of at least 5/10 at baseline evaluation
- MRI (or CT if MRI not available) shows one or two level cervical disc herniation(s) or disc osteophyte complex(es) between levels C4-T1, corresponding in location with unilateral radicular pain, with or without neurological deficits. MRI or CT may show degenerative changes at other levels.
- Patient consents to treatment with epidural injection in a shared decision-making process with the treating physician.
Key exclusion criteria (19 listed)
- - Neck pain is greater than arm pain or shoulder girdle/periscapular pain based on 7 day average NPRS
- Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
- Those involved in active litigation relevant to their pain.
- Those unable to read English and complete the assessment instruments.
- Those unable to attend follow up appointments
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 |
|---|---|---|
| Transforaminal Epidural Steroid Injection with DexamethasoneAlso: DecadronTransforaminal Epidural Steroid Injection with Dexamethasone | Drug | Tranforaminal |
| Interlaminar Epidural Steroid Injection with BetamethasoneInterlaminar Epidural Steroid Injection with Betamethasone | Drug | Interlaminar |
Primary outcome
Pain
Time frame: 12 months
Numeric rating pain score
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Individual participant dataSharing planned: No
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Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
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Assessing Microbiome in Primary Anterior Cervical Fusion Patients
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Gelified Radiopaque Ethanol (Absolute Gel) in Cervical Disc Herniation: an Observational Study in Routine Clinical Practice (GENESIS)
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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.
Byron Schneider principal investigator
Assistant professor
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transforaminal Epidural Steroid Injection with Dexamethasone and Interlaminar Epidural Steroid Injection with Betamethasone in people with Cervical Radiculopathy, run by Vanderbilt University Medical Center.
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 6 inclusion and 19 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: withdrawn, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain (time frame: 12 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 4 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.