Unilateral Lumbosacral Radiculopathy Pain Clinical Trial
Official title:
Midline vs Lateral Parasagittal Approach During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection: the Role of Concordant Pressure Paresthesia in Determing Outcome.
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:
- Group I (50 patients) - will get LESI using midline (MIL) approach.
- Group II (50 patients) - will get LESI using parasagittal interlaminar (PIL) approach.
| Status | Completed |
| Enrollment | 106 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - 18- 80 years old - History of low back pain and unilateral lumbosacral radiculopathy pain - Lumbar disk disease including disk herniations, bulging discs, and degenerated discs, where at least 50% of the disk height is preserved respective to contiguous levels Exclusion Criteria: - Discogenic pain without radiculopathy pain - History of previous spinal surgery - LESI(s) in the past year - Allergy to methylprednisolone, or lidocaine, or iodine-based contrast - Concurrent use of systemic steroid medications - Opioid habituation - Pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Chicago Anesthesia Pain Specialits | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Kenneth D Candido |
United States,
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection | Days 1, 7, 14, 21, 28, 60, 120, 180, 360 | No | |
| Primary | Pressure Paresthesia during injection | 1 day (During Lumbar Epidural Steroid Injection) | No | |
| Primary | Quality of life improvement change after Lumbar Epidural Steroid Injection | Days 1, 7, 14, 21, 28, 60, 120, 180, 360 | No |