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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Steroid Injection Patients | Patients who are to receive an epidural steroid injection as an outpatient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post Epidural Steroid Injection Follow-up | Behavioral | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with low back pain who are to undergo Epidural Steroid Injection for pain relief.
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| Name | Affiliation | Role |
|---|---|---|
| Byron J Schneider, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stallworth Rehabilitation Hospital | Nashville | Tennessee | 37212 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D013130 | Spinal Stenosis |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 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) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |