Clinical trial NCT01760317: Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection
Official title: Midline vs Lateral Parasagittal Approach During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection: the Role of Concordant Pressure Paresthesia in Determing Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Lumbosacral Radiculopathy Pain
Lead sponsor: Chicago Anesthesia Pain Specialists
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection
timeFrame: Days 1, 7, 14, 21, 28, 60, 120, 180, 360
measure: Pressure Paresthesia during injection
timeFrame: 1 day (During Lumbar Epidural Steroid Injection)
measure: Quality of life improvement change after Lumbar Epidural Steroid Injection
timeFrame: Days 1, 7, 14, 21, 28, 60, 120, 180, 360
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago Anesthesia Pain Specialits
state: Illinois
Study officials:
References:
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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.
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.