Clinical trial NCT03534531: Cortisone Shots for Neck Pain
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Cervicalgia
Facet Joint Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Change in Numeric Pain Rating Scale
timeFrame: Baseline, 2-4 weeks, and 3 months
Secondary outcomes:
measure: Neck Disability Index
timeFrame: Baseline, 2-4 weeks, and 3 months
measure: Work status
timeFrame: Baseline, 2-4 weeks, and 3 months
measure: Medication use
timeFrame: Baseline, 2-4 weeks, and 3 months
measure: Use of other treatments
timeFrame: Baseline, 2-4 weeks, and 3 months
measure: Global Assessment of Change
timeFrame: 2-4 weeks and 3 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References: