Cortisone Shots for Neck Pain

Completed

• Conditions: Neck Pain; Cervicalgia; Facet Joint Pain

• Registration Number: NCT03534531
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-05-23
• Study Start: 2018-07-19
• Primary Completion: 2023-11-26
• Study Completion: 2023-11-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Use of other treatments	Baseline, 2-4 weeks, and 3 months	Yes or No explaining if the patient is using other health care resources
Neck Disability Index	Baseline, 2-4 weeks, and 3 months	Measure of neck pain related disability, scored between 0-50 with 0 being no disability and higher numbers being higher levels of disability
Work status	Baseline, 2-4 weeks, and 3 months	Yes or No explaining if the patient is working
Global Assessment of Change	2-4 weeks and 3 months	Question asking if the patient is improved, the same, or worse
Medication use	Baseline, 2-4 weeks, and 3 months	Yes or No explaining if the patient is taking pain medication

Trial Locations

Locations (2)

Stanford University; 🇺🇸 Redwood City, California, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States