Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

NCT03165825 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB #170187
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

compare cervical interlaminar epidural injection of betamethasone (9mg) and cervical transforaminal epidural injection of dexamethasone (15 mg) for cervical radicular pain

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Pain

  Numeric rating pain score

  12 months

Study Arms (2)

Tranforaminal

EXPERIMENTAL

will receive cervical epidural injection via a transforaminal route with dexamethasone steroid

Drug: Transforaminal Epidural Steroid Injection with Dexamethasone

Interlaminar

ACTIVE COMPARATOR

will receive cervical epidural injection via an interlaminar route with betamethasone steroid

Drug: Interlaminar Epidural Steroid Injection with Betamethasone

Interventions

Transforaminal Epidural Steroid Injection with Dexamethasone DRUG

Transforaminal Epidural Steroid Injection with Dexamethasone

Also known as: Decadron

Tranforaminal

Interlaminar Epidural Steroid Injection with Betamethasone DRUG

Interlaminar Epidural Steroid Injection with Betamethasone

Interlaminar

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• 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.

You may not qualify if:

• \- 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.
• 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).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

MeSH Terms

Conditions

Radiculopathy

Interventions

Dexamethasone; Calcium Dobesilate; Betamethasone

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Byron Schneider

  Assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 24, 2017
• Study Start: January 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share