Depo-Medrol on Psoas After LLIF

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHardeep Singh

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Depo-Medrol

    Drug

    steroid

  • Gel-Flow NT

    Drug

    hemostatic agent

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Control group (standard care)Placebo comparator 1 intervention
Group B: Test group (standard care + study intervention)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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"?

Time frame
2-3 weeks following surgery
2

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"?

Time frame
6 weeks following surgery
3

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"?

Time frame
12 weeks following surgery

Secondary outcomes

1

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

Time frame
6 months, 1 year, 2 years
2

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

Time frame
6 months, 1 year, 2 years
3

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."

Time frame
2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
4

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).

Time frame
2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hardeep Singh

Lead sponsor

UConn Health

Sponsor institution

Society for Minimally Invasive Spine Surgery

Collaborator