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

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

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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