- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04207606
Post Epidural Steroid Injection Follow-up
March 11, 2021 updated by: Byron Schneider, Vanderbilt University Medical Center
Follow-up of Pain Intensity Post Epidural Steroid Injection
To determine the expected pain response timeline for patients receiving epidural steroid injections, our team plans to assess patient pain severity and degree of pain relief every 3 days for 23 days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients who are already planning to receive an epidural steroid injection from their physiatrist will be approached by study members on the day of their injection.
If enrolled, the patients will be contacted every 3 days for 23 days to determine the severity of pain and degree of pain relief from the injection.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37212
- Stallworth Rehabilitation Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients with low back pain who are to undergo Epidural Steroid Injection for pain relief.
Description
Inclusion Criteria:
- Any patient schedule for an epidural steroid injection (ESI) at Stallworth Rehabilitation Hospital through the department of Physical Medicine & Rehabilitation.
- The epidural steroid injection will be performed as part of standard clinical care, this study only aims to describe the clinical response to the procedure.
Exclusion Criteria:
- ESI has been performed within the last 6 months
- Steroid injection elsewhere in body within last 8 weeks
- Oral or intramuscular steroids within last 8 weeks
- Unwilling or unable to provide informed consent
- Unable to comply with required follow up
- Please note that it is assumed that a patient scheduled for an epidural steroid injection clinically is assumed to not have any contraindications to the injection itself such as active systemic infection or pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Epidural Steroid Injection Patients
Patients who are to receive an epidural steroid injection as an outpatient.
|
All enrolled patients will undergo epidural steroid injection with fluoroscopy per the Spine Intervention Society guidelines as part of their normal care.
Patients will then be contacted for survey responses every 3 days for a maximum of 23 days, to assess pain intensity and change.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: post-procedure day 1 (+1 day)
|
The NPRS measures pain intensity.
Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain.
This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 1 (+ 1 day)
|
post-procedure day 1 (+1 day)
|
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: post-procedure day 4 (+/- 1 day)
|
The NPRS measures pain intensity.
Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain.
This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 4 (+/- 1 day)
|
post-procedure day 4 (+/- 1 day)
|
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: post-procedure day 7 (+/- 1 day)
|
The NPRS measures pain intensity.
Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain.
This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 7 (+/- 1 day)
|
post-procedure day 7 (+/- 1 day)
|
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: post-procedure day 10 (+/- 1 day)
|
The NPRS measures pain intensity.
Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain.
This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 10 (+/- 1 day)
|
post-procedure day 10 (+/- 1 day)
|
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: post-procedure day 13 (+/- 1 day)
|
The NPRS measures pain intensity.
Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain.
This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 13 (+/- 1 day)
|
post-procedure day 13 (+/- 1 day)
|
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: post-procedure day 16 (+/- 1 day)
|
The NPRS measures pain intensity.
Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain.
This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 16 (+/- 1 day)
|
post-procedure day 16 (+/- 1 day)
|
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: post-procedure day 19 (+/- 1 day)
|
The NPRS measures pain intensity.
Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain.
This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 19 (+/- 1 day)
|
post-procedure day 19 (+/- 1 day)
|
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: post-procedure day 22 (+/- 1 day)
|
The NPRS measures pain intensity.
Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain.
This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 22 (+/- 1 day)
|
post-procedure day 22 (+/- 1 day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Rating of Change
Time Frame: Every 3 days for up to 23 days
|
Measures reduction in pain intensity.
Range: 0 to 100%, with 0% representing no change in pain and 100% representing complete relief of index pain.
|
Every 3 days for up to 23 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Byron J Schneider, MD, Vanderbilt University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2020
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
December 10, 2019
First Submitted That Met QC Criteria
December 18, 2019
First Posted (Actual)
December 23, 2019
Study Record Updates
Last Update Posted (Actual)
March 12, 2021
Last Update Submitted That Met QC Criteria
March 11, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11192019110246
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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