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Trial record 93 of 275 for:    Betamethasone

Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

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ClinicalTrials.gov Identifier: NCT03165825
Recruitment Status : Withdrawn (funding)
First Posted : May 24, 2017
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Byron Schneider, Vanderbilt University Medical Center

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

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Drug: Transforaminal Epidural Steroid Injection with Dexamethasone Drug: Interlaminar Epidural Steroid Injection with Betamethasone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranforaminal
will receive cervical epidural injection via a transforaminal route with dexamethasone steroid
Drug: Transforaminal Epidural Steroid Injection with Dexamethasone
Transforaminal Epidural Steroid Injection with Dexamethasone
Other Name: Decadron

Active Comparator: Interlaminar
will receive cervical epidural injection via an interlaminar route with betamethasone steroid
Drug: Interlaminar Epidural Steroid Injection with Betamethasone
Interlaminar Epidural Steroid Injection with Betamethasone




Primary Outcome Measures :
  1. Pain [ Time Frame: 12 months ]
    Numeric rating pain score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165825


Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Byron Schneider Assistant professor

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Responsible Party: Byron Schneider, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03165825     History of Changes
Other Study ID Numbers: IRB #170187
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Asthmatic Agents
Respiratory System Agents