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Cortisone Shots for Neck Pain

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ClinicalTrials.gov Identifier: NCT03534531
Recruitment Status : Unknown
Verified April 2019 by Joshua Levin, Stanford University.
Recruitment status was:  Recruiting
First Posted : May 23, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Levin, Stanford University

Brief Summary:
The purpose of this study is to determine if cortisone shots in the neck are helpful in patients with certain MRI findings. Additionally, the investigators hope to learn if cervical facet joint steroid injections are beneficial in the subset of patients with MRI findings consistent with facet joint synovitis.

Condition or disease Intervention/treatment
Neck Pain Cervicalgia Facet Joint Pain Procedure: Intra-articular cervical zygapophyseal joint injection

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Study Type : Observational
Estimated Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Trial of Intra-Articular Cervical Zygapophyseal Joint Corticosteroid Injections in Patients With Increased Peri-Zygapophyseal Joint MRI Short Tau Inversion Recovery Signal
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Intra-articular cervical zygapophyseal joint injection
    Fluoroscopically-guided intra-articular cervical zygapophyseal steroid injection
    Other Name: Injection of methylprednisolone


Primary Outcome Measures :
  1. Change in Numeric Pain Rating Scale [ Time Frame: Baseline, 2-4 weeks, and 3 months ]
    0 to 10 scale grading severity of pain


Secondary Outcome Measures :
  1. Neck Disability Index [ Time Frame: Baseline, 2-4 weeks, and 3 months ]
    Measure of neck pain related disability, scored between 0-50 with 0 being no disability and higher numbers being higher levels of disability

  2. Work status [ Time Frame: Baseline, 2-4 weeks, and 3 months ]
    Yes or No explaining if the patient is working

  3. Medication use [ Time Frame: Baseline, 2-4 weeks, and 3 months ]
    Yes or No explaining if the patient is taking pain medication

  4. Use of other treatments [ Time Frame: Baseline, 2-4 weeks, and 3 months ]
    Yes or No explaining if the patient is using other health care resources

  5. Global Assessment of Change [ Time Frame: 2-4 weeks and 3 months ]
    Question asking if the patient is improved, the same, or worse



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will be done on patients with neck pain who have a specific MRI finding. Patients who are at least 18 years old and have had neck pain for at least 4 weeks may be eligible.
Criteria

Inclusion Criteria:

  • at least 18 years old
  • Patient who will be getting a neck cortisone shot for pain that has been there for at least 4 weeks
  • A specific MRI finding (increased Short Tau Inversion Recovery signal) around 1 or more of the joints in the neck

Exclusion Criteria:

  • Those receiving disability, worker's compensation, or are involved in litigation related to their pain.
  • Those unable to read English and complete the assessment instruments.
  • Those unable to attend follow up appointments
  • The patient is incarcerated.
  • Grade 2 or greater spondylolisthesis at the involved or adjacent segments.
  • History of prior posterior cervical surgery. Anterior cervical surgery is not an exclusion criteria.
  • Progressive motor deficit, and/or clinical signs of myelopathy.
  • Prior neck cortisone shots within the past 6 months.
  • 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.
  • 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): NCT03534531


Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Erin Nelligan    650-721-7627    erinnelligan@stanford.edu   
Stanford University Recruiting
Redwood City, California, United States, 94063
Contact: Erin Nelligan    650-721-7627    erinnelligan@stanford.edu   
United States, Tennessee
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37212
Contact: Reza Ehsanian, MD    615-936-7708    reza.ehsanian@vanderbilt.edu   
Contact: Byron Schneider, MD    615-936-7708    byron.schneider@vanderbilt.edu   
Principal Investigator: Byron Schneider, MD         
Sub-Investigator: David J Kennedy, MD         
Sponsors and Collaborators
Stanford University
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Responsible Party: Joshua Levin, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03534531    
Other Study ID Numbers: IRB-45400
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
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
Additional relevant MeSH terms:
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Arthralgia
Neck Pain
Pain
Neurologic Manifestations
Joint Diseases
Musculoskeletal Diseases
Methylprednisolone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents