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NCT Number: NCT05929755

Depo-Medrol on Psoas After LLIF

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.

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Key information

Conditions

Muscle Weakness Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pain Pain, Muscle Pain, Postoperative Paresthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UConn Health

Farmington, Connecticut, 06030, United States

Location status: Recruiting

Location contact

Hardeep Singh, M.D.

PRINCIPAL_INVESTIGATOR

Isaac Moss, M.D., C.M., M.A.Sc., FRCSC

SUB_INVESTIGATOR

Scott Mallozzi, M.D.

SUB_INVESTIGATOR

Study Coordinator

CONTACT

[email protected]

About this study

Primary Objective and Outcome Measure:

  • 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.

Secondary Objectives and Outcome Measures:

  • Quantify the difference in rates and severity of postoperative hip flexor weakness, and 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.
  • Quantity patient reported outcomes measures (PROMs) (EQ5D, ODI, and sciatica Bothersome index between those that did and did not receive a depo-medrol injection. Specifically:
  • EQ5D: Eur-Quality of Life 5 dimension questionnaire
  • ODI: Oswestry Disability Index
  • Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection.

Ancillary Objectives and Outcome Measures:

  • To determine the effect of clinically relevant covariates including sociodemographic and comorbidities on the course of postoperative pain and associated outcome measures and whether the effect of these covariates moderate the effect of postoperative pain.

Groups:

  • Control group (standard care) - 1cc gel foam powder mixed with thrombin
  • Steroid group (standard care + study intervention) - 1cc gel foam powder mixed with thrombin and 80mg depomedrol

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patients between ages of 18 and 75

Exclusion criteria

  • Scoliosis >10°
  • Spondylolisthesis >Grade 1
  • Flatback deformity
  • Patients with insulin dependent diabetes
  • Patients with >3 levels of fusion
  • Alternative interbodies
  • Chronic oral steroid users
  • Patients with allergy/intolerance to depo-medrol or other steroids
  • Patients requiring bilateral transpsoas approaches
  • Patients with ipsilateral symptomatic hip pathology
  • Revision fusion procedures
  • Cases involving trauma, tumor, or infection
  • Patient's not capable of providing consent themselves
  • Non-fluent English speakers (for consenting reasons)
  • Patients who are lost to follow-up before the two year follow up period

Treatment and study plan

Depo-Medrol

Drug

steroid

Gel-Flow NT

Drug

hemostatic agent

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.

    Time frame: 2-3 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"?

  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.

    Time frame: 6 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"?

  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.

    Time frame: 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

  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.

    Time frame: 6 months, 1 year, 2 years

    Thigh numbness - binary: yes/no

  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.

    Time frame: 6 months, 1 year, 2 years

    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

    • Trace muscle activation, such as a twitch, without achieving full range of motion
    • Muscle activation with gravity eliminated, achieving full range of motion
    • Muscle activation against gravity, full range of motion
    • Muscle activation against some resistance, full range of motion
    • Muscle activation against examiner's full resistance, full range of motion

  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)

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

    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."

  4. Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Oswestry Disability Index (ODI)

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

    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).

  5. Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Sciatica Bothersomeness Index

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

    Sciatica Bothersomeness index includes self-reported ratings of symptom intensity of:

    • Leg pain
    • Numbness or tingling in the leg, foot or groin
    • Weakness in the leg/foot
    • Back or leg pain while sitting

    Each symptom item is rated on a scale from 0 to 6, with 0 being not bothersome, 3 somewhat bothersome and 6 extremely bothersome.

  6. Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection.

    Time frame: 1 year and 2 years

    Fusion rate - Assessed with Flexion, Extension X-ray (screw loosening/fracture, instability)

    CT Scan if patient has a symptomatic (pain) pseudoarthrosis (lack of fusion)

Study contacts

Contact information is provided by the study sponsor or research team.

Hardeep Singh, MD

CONTACT

[email protected]

860-679-6883

Study Coordinator

CONTACT

[email protected]

860-679-6883

Sponsors and collaborators

Lead sponsor

Hardeep Singh

Other

Collaborators

  • Society for Minimally Invasive Spine Surgery

Registry information

Official study title

Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jul 3, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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