Neck Pain Clinical Trial
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
NCT number | NCT03534531 |
Other study ID # | IRB-45400 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 19, 2018 |
Est. completion date | December 1, 2023 |
Verified date | May 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 37 |
Est. completion date | December 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nashville | Tennessee |
United States | Stanford University | Palo Alto | California |
United States | Stanford University | Redwood City | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Numeric Pain Rating Scale | 0 to 10 scale grading severity of pain | Baseline, 2-4 weeks, and 3 months | |
Secondary | 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 | |
Secondary | Work status | Yes or No explaining if the patient is working | Baseline, 2-4 weeks, and 3 months | |
Secondary | Medication use | Yes or No explaining if the patient is taking pain medication | Baseline, 2-4 weeks, and 3 months | |
Secondary | Use of other treatments | Yes or No explaining if the patient is using other health care resources | Baseline, 2-4 weeks, and 3 months | |
Secondary | Global Assessment of Change | Question asking if the patient is improved, the same, or worse | 2-4 weeks and 3 months |
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