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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03534531
Other study ID # IRB-45400
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 19, 2018
Est. completion date December 1, 2023

Study information

Verified date May 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 37
Est. completion date December 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intra-articular cervical zygapophyseal joint injection
Fluoroscopically-guided intra-articular cervical zygapophyseal steroid injection

Locations

Country Name City State
United States Vanderbilt University Nashville Tennessee
United States Stanford University Palo Alto California
United States Stanford University Redwood City California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Numeric Pain Rating Scale 0 to 10 scale grading severity of pain Baseline, 2-4 weeks, and 3 months
Secondary Neck Disability Index Measure of neck pain related disability, scored between 0-50 with 0 being no disability and higher numbers being higher levels of disability Baseline, 2-4 weeks, and 3 months
Secondary Work status Yes or No explaining if the patient is working Baseline, 2-4 weeks, and 3 months
Secondary Medication use Yes or No explaining if the patient is taking pain medication Baseline, 2-4 weeks, and 3 months
Secondary Use of other treatments Yes or No explaining if the patient is using other health care resources Baseline, 2-4 weeks, and 3 months
Secondary Global Assessment of Change Question asking if the patient is improved, the same, or worse 2-4 weeks and 3 months
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