Cortisone Shots for Neck Pain

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03534531
• Other study ID #: IRB-45400
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Arthralgia
• Cervicalgia
• Facet Joint Pain
• Neck Pain

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