Cortisone Shots for Neck Pain

Prospective Observational Trial of Intra-Articular Cervical Zygapophyseal Joint Corticosteroid Injections in Patients With Increased Peri-Zygapophyseal Joint MRI Short Tau Inversion Recovery Signal

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain; Facet Joint Pain; Cervicalgia
• Intervention / Treatment: Procedure: Intra-articular cervical zygapophyseal joint injection

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University
    • Redwood City, California, United States, 94063
      • Stanford University
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Numeric Pain Rating Scale	0 to 10 scale grading severity of pain	Baseline, 2-4 weeks, and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Work status	Yes or No explaining if the patient is working	Baseline, 2-4 weeks, and 3 months
Medication use	Yes or No explaining if the patient is taking pain medication	Baseline, 2-4 weeks, and 3 months
Use of other treatments	Yes or No explaining if the patient is using other health care resources	Baseline, 2-4 weeks, and 3 months
Global Assessment of Change	Question asking if the patient is improved, the same, or worse	2-4 weeks and 3 months

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): November 26, 2023
• Study Completion (Actual): November 26, 2023

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Neck Pain
• Other Study ID Numbers: IRB-45400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No