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OpenTrials
Completed

NCT Number: NCT03534531

Cortisone Shots for Neck Pain

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.

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Key information

Conditions

Neck Pain Cervicalgia Facet Joint Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intra-articular cervical zygapophyseal joint injection

Procedure

Fluoroscopically-guided intra-articular cervical zygapophyseal steroid injection

Primary outcomes

  1. Change in Numeric Pain Rating Scale

    Time frame: Baseline, 2-4 weeks, and 3 months

    0 to 10 scale grading severity of pain

Secondary outcomes

  1. Neck Disability Index

    Time frame: 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

  2. Work status

    Time frame: Baseline, 2-4 weeks, and 3 months

    Yes or No explaining if the patient is working

  3. Medication use

    Time frame: Baseline, 2-4 weeks, and 3 months

    Yes or No explaining if the patient is taking pain medication

  4. Use of other treatments

    Time frame: Baseline, 2-4 weeks, and 3 months

    Yes or No explaining if the patient is using other health care resources

  5. Global Assessment of Change

    Time frame: 2-4 weeks and 3 months

    Question asking if the patient is improved, the same, or worse

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 23, 2018
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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