Post Epidural Steroid Injection Follow-up

Study Overview
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Brief Summary
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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
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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.

Official Title
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Follow-up of Pain Intensity Post Epidural Steroid Injection

Conditions
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Lumbago, Lumbar Spinal Stenosis, Lumbar Disc Herniation

Intervention / Treatment
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* Behavioral: Post Epidural Steroid Injection Follow-up


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epidural Steroid Injection Patients<br>Patients who are to receive an epidural steroid injection as an outpatient. | Behavioral: Post Epidural Steroid Injection Follow-up<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numeric Pain Rating Scale (NPRS) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural steroid, lumbar back pain, Pharmacokinetics, Timeline, Natural History