Clinical trial NCT04207606: Post Epidural Steroid Injection Follow-up
Official title: Follow-up of Pain Intensity Post Epidural Steroid Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbago
Lumbar Spinal Stenosis
Lumbar Disc Herniation
Keywords: epidural steroid
lumbar back pain
Pharmacokinetics
Timeline
Natural History
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with low back pain who are to undergo Epidural Steroid Injection for pain relief.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: post-procedure day 1 (+1 day)
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: post-procedure day 4 (+/- 1 day)
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: post-procedure day 7 (+/- 1 day)
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: post-procedure day 10 (+/- 1 day)
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: post-procedure day 13 (+/- 1 day)
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: post-procedure day 16 (+/- 1 day)
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: post-procedure day 19 (+/- 1 day)
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: post-procedure day 22 (+/- 1 day)
Secondary outcomes:
measure: Global Rating of Change
timeFrame: Every 3 days for up to 23 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Stallworth Rehabilitation Hospital
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Byron J Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References: