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Cortisone Shots for Neck Pain

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03534531
Collaborator
(none)
37
Enrollment
3
Locations
64.4
Anticipated Duration (Months)
12.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intra-articular cervical zygapophyseal joint injection

Study Design

Study Type:
Observational
Anticipated Enrollment :
37 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jul 19, 2018
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Change in Numeric Pain Rating Scale [Baseline, 2-4 weeks, and 3 months]

    0 to 10 scale grading severity of pain

Secondary Outcome Measures

  1. 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

  2. Work status [Baseline, 2-4 weeks, and 3 months]

    Yes or No explaining if the patient is working

  3. Medication use [Baseline, 2-4 weeks, and 3 months]

    Yes or No explaining if the patient is taking pain medication

  4. Use of other treatments [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 [2-4 weeks and 3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Palo Alto California United States 94304
2 Stanford University Redwood City California United States 94063
3 Vanderbilt University Nashville Tennessee United States 37212

Sponsors and Collaborators

  • Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joshua Levin, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT03534531
Other Study ID Numbers:
  • IRB-45400
First Posted:
May 23, 2018
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthralgia
Neck Pain

Study Results

No Results Posted as of May 13, 2022