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The purpose of this study is to compare two different approaches (midline and parasagittal) during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of concordant pressure paresthesia occurring during the LESI in determining outcome.
The investigators are planning to include 100 patients, undergoing LESI for radicular low back pain. This will be single-blinded randomized study. Every patient will receive the same medication we would use regardless of participating in the study. The patients will be randomly assigned to one of two groups, based on the approach:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midline | Active Comparator | Midline Lumbar Epidural Steroid Injection |
|
| Parasagittal | Active Comparator | Parasagittal Lumbar Epidural Steroid Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midline vs Parasagittal Lumbar Epidural Steroid Injection | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection | Days 1, 7, 14, 21, 28, 60, 120, 180, 360 | |
| Pressure Paresthesia during injection | 1 day (During Lumbar Epidural Steroid Injection) | |
| Quality of life improvement change after Lumbar Epidural Steroid Injection | Days 1, 7, 14, 21, 28, 60, 120, 180, 360 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago Anesthesia Pain Specialits | Chicago | Illinois | 60657 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16850041 | Background | Boswell MV, Shah RV, Everett CR, Sehgal N, McKenzie Brown AM, Abdi S, Bowman RC 2nd, Deer TR, Datta S, Colson JD, Spillane WF, Smith HS, Lucas LF, Burton AW, Chopra P, Staats PS, Wasserman RA, Manchikanti L. Interventional techniques in the management of chronic spinal pain: evidence-based practice guidelines. Pain Physician. 2005 Jan;8(1):1-47. | |
| 17256030 |
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| Abdi S, Datta S, Trescot AM, Schultz DM, Adlaka R, Atluri SL, Smith HS, Manchikanti L. Epidural steroids in the management of chronic spinal pain: a systematic review. Pain Physician. 2007 Jan;10(1):185-212. |
| 16858489 | Background | Manchikanti L. The growth of interventional pain management in the new millennium: a critical analysis of utilization in the medicare population. Pain Physician. 2004 Oct;7(4):465-82. |
| 17256025 | Background | Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L; American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007 Jan;10(1):7-111. |
| 19165306 | Background | Buenaventura RM, Datta S, Abdi S, Smith HS. Systematic review of therapeutic lumbar transforaminal epidural steroid injections. Pain Physician. 2009 Jan-Feb;12(1):233-51. |
| 18227326 | Background | Candido KD, Raghavendra MS, Chinthagada M, Badiee S, Trepashko DW. A prospective evaluation of iodinated contrast flow patterns with fluoroscopically guided lumbar epidural steroid injections: the lateral parasagittal interlaminar epidural approach versus the transforaminal epidural approach. Anesth Analg. 2008 Feb;106(2):638-44, table of contents. doi: 10.1213/ane.0b013e3181605e9b. |