Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

Cervical Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03165825
• Other study ID #: IRB #170187
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2018
• Est. completion date: October 2019

Study information

• Verified date: October 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• - 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.

Exclusion Criteria:

• - 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).

• 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.

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Drug:
• Transforaminal Epidural Steroid Injection with Dexamethasone
Transforaminal Epidural Steroid Injection with Dexamethasone
• Interlaminar Epidural Steroid Injection with Betamethasone
Interlaminar Epidural Steroid Injection with Betamethasone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Numeric rating pain score	12 months