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Post Epidural Steroid Injection Follow-up

Follow-up of Pain Intensity Post Epidural Steroid Injection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04207606
Enrollment
100
Registered
2019-12-23
Start date
2020-01-03
Completion date
2020-12-01
Last updated
2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbago, Lumbar Disc Herniation, Lumbar Spinal Stenosis

Keywords

epidural steroid, lumbar back pain, Pharmacokinetics, Timeline, Natural History

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.

Interventions

BEHAVIORALPost Epidural Steroid Injection Follow-up

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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Numeric Pain Rating Scale (NPRS)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)

Secondary

MeasureTime frameDescription
Global Rating of ChangeEvery 3 days for up to 23 daysMeasures reduction in pain intensity. Range: 0 to 100%, with 0% representing no change in pain and 100% representing complete relief of index pain.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026