Neck PainNCT03534531
Cortisone Shots for Neck Pain
An observational study of Neck Pain and Cervicalgia, run by Stanford University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain, Cervicalgia, Facet Joint Pain
- What is being tested?
- Intra-articular cervical zygapophyseal joint injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jul 2018to 26 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt University
Nashville, Tennessee, 37212
Stanford University
Palo Alto, California, 94304
Stanford University
Redwood City, California, 94063
About this study
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
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
- Being tested
- Intra-articular cervical zygapophyseal joint injection
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular cervical zygapophyseal joint injectionProcedure or surgery
Fluoroscopically-guided intra-articular cervical zygapophyseal steroid injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Pain Rating Scale
0 to 10 scale grading severity of pain
Measured: Baseline, 2-4 weeks, and 3 months
Secondary outcomes (5)
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
Measured: Baseline, 2-4 weeks, and 3 months
Work status
Yes or No explaining if the patient is working
Measured: Baseline, 2-4 weeks, and 3 months
Medication use
Yes or No explaining if the patient is taking pain medication
Measured: Baseline, 2-4 weeks, and 3 months
Use of other treatments
Yes or No explaining if the patient is using other health care resources
Measured: Baseline, 2-4 weeks, and 3 months
Global Assessment of Change
Question asking if the patient is improved, the same, or worse
Measured: 2-4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start19 Jul 2018
- Primary completion26 Nov 2023
- Study completion26 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Levin, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534531
- Sponsor's protocol ID
- IRB-45400
- Status last verified
- Jun 2024
- First submitted
- 26 Apr 2018
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03534531
- Acronym / sponsor ID
- IRB-45400
- Conditions
- Neck Pain, Cervicalgia, Facet Joint Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 26 Nov 2023 (actual)
- Study completion
- 26 Nov 2023 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular cervical zygapophyseal joint injectionFluoroscopically-guided intra-articular cervical zygapophyseal steroid injection | Procedure or surgery | – |
Primary outcome
Change in Numeric Pain Rating Scale
Time frame: Baseline, 2-4 weeks, and 3 months
0 to 10 scale grading severity of pain
5 secondary outcomes
Neck Disability Index
Time frame: Baseline, 2-4 weeks, and 3 months
Work status
Time frame: Baseline, 2-4 weeks, and 3 months
Medication use
Time frame: Baseline, 2-4 weeks, and 3 months
Use of other treatments
Time frame: Baseline, 2-4 weeks, and 3 months
Global Assessment of Change
Time frame: 2-4 weeks and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Cervicalgia, run by Stanford University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Pain Rating Scale (time frame: Baseline, 2-4 weeks, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.