Cortisone Shots for Neck Pain

NCT03534531 | Completed

• 1 other identifier: IRB-45400
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Neck Pain; Cervicalgia; Facet Joint Pain

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Pain Rating Scale

  0 to 10 scale grading severity of pain

  Baseline, 2-4 weeks, and 3 months

Secondary Outcomes (5)

• Neck Disability Index

  Baseline, 2-4 weeks, and 3 months

• Work status

  Baseline, 2-4 weeks, and 3 months

• Medication use

  Baseline, 2-4 weeks, and 3 months

• Use of other treatments

  Baseline, 2-4 weeks, and 3 months

• Global Assessment of Change

  2-4 weeks and 3 months

Interventions

Intra-articular cervical zygapophyseal joint injection PROCEDURE

Fluoroscopically-guided intra-articular cervical zygapophyseal steroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (3)

Stanford University

Palo Alto, California, 94304, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 23, 2018
• Study Start: July 19, 2018
• Primary Completion: November 26, 2023
• Study Completion: November 26, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)