Post Epidural Steroid Injection Follow-up

Completed

• Conditions: Lumbar Spinal Stenosis; Lumbago; Lumbar Disc Herniation
• Interventions: Behavioral: Post Epidural Steroid Injection Follow-up

• Registration Number: NCT04207606
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-23
• Study Start: 2020-01-03
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epidural Steroid Injection Patients	Post Epidural Steroid Injection Follow-up	Patients who are to receive an epidural steroid injection as an outpatient.

Primary Outcome Measures

Name	Time	Method
Change in Numeric Pain Rating Scale (NPRS)	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)

Secondary Outcome Measures

Name	Time	Method
Global Rating of Change	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.

Trial Locations

Locations (1)

Stallworth Rehabilitation Hospital; 🇺🇸 Nashville, Tennessee, United States