Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

• Status: Withdrawn
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: BB 1101; Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.