Post Epidural Steroid Injection Follow-up

Lumbar Spinal Stenosis Clinical Trial

Official title:

Follow-up of Pain Intensity Post Epidural Steroid Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207606
• Other study ID #: 11192019110246
• Status: Completed
• Start date: January 3, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lumbago
• Lumbar Disc Herniation
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Behavioral:
• Post 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.

Locations

Country	Name	City	State
United States	Stallworth Rehabilitation Hospital	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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