About this trial
The goal of this study is to determine the effects of a corticosteroid administered to the psoas muscle following a transpsoas lateral lumbar interbody fusion (LLIF) on postoperative hip flexor weakness and thigh pain and numbness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients from the practices of Drs. Singh, Mallozzi, Moss
Transpsoas (PTP or LTP) lateral lumbar interbody fusion (LLIF) 1-3 disc levels with posterior instrumentation (Open or MIS) with or without laminectomy, must include L3-4 and/or L4-5
Patients who agree to be a part of the study
Patients with lumbar disc degeneration
Disqualifiers
Scoliosis >10°
Spondylolisthesis >Grade 1
Flatback deformity
Patients with insulin dependent diabetes
Trial design
Parallel
Treatments tested in this trial
Depo-Medrol
Drugsteroid
Gel-Flow NT
Drughemostatic agent
Treatment groups
Trial outcomes
Primary outcomes
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.
Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from "no pain" to "worst pain imaginable"?
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.
Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from "no pain" to "worst pain imaginable"?
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.
Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from "no pain" to "worst pain imaginable"?
Secondary outcomes
Quantify the difference in rates of postoperative thigh numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.
Thigh numbness - binary: yes/no
Quantify the difference in severity of postoperative hip flexor weakness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.
Hip flexion strength measured via graded exam: the Medical Research Council Manual Muscle Testing scale. This method involves testing key muscles from the lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: 0 No muscle activation 1. Trace muscle activation, such as a twitch, without achieving full range of motion 2. Muscle activation with gravity eliminated, achieving full range of motion 3. Muscle activation against gravity, full range of motion 4. Muscle activation against some resistance, full range of motion 5. Muscle activation against examiner's full resistance, full range of motion
Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Euro-Quality of Life 5 dimension questionnaire (EQ5D)
The Euro-Quality of Life 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems."
Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is an outcome measure that was designed to assess function in activities of daily living for those with acute or chronic back pain. The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).
Sponsors and contacts
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Hardeep Singh
Lead sponsor
UConn Health
Sponsor institution
Society for Minimally Invasive Spine Surgery
Collaborator