Effects of Depo-Medrol on Psoas Muscle After Lumbar Spine Surgery
Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness
This study tests if giving a corticosteroid called Depo-Medrol to the psoas muscle after lumbar spine surgery can help reduce thigh pain and improve hip strength compared to patients who don’t receive the injection.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | UConn Health Academic / other |
| Locations | 1 site (Farmington, Connecticut) |
| Trial ID | NCT05929755 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of administering a corticosteroid, Depo-Medrol, to the psoas muscle following a transpsoas lateral lumbar interbody fusion (LLIF) procedure. It aims to assess differences in postoperative thigh pain, hip flexor weakness, and numbness between patients receiving the injection and those who do not. The study will measure outcomes at three postoperative intervals: 2-3 weeks, 6 weeks, and 12 weeks, using various pain and quality of life scales. Additionally, it will evaluate the effect of Depo-Medrol on fusion rates and consider how patient demographics and comorbidities influence outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 undergoing LLIF for lumbar disc degeneration.
Not a fit: Patients with significant spinal deformities, chronic steroid use, or certain comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and improve recovery for patients undergoing lumbar spine surgery.
How similar studies have performed: While corticosteroid use in postoperative settings has been explored, this specific application in LLIF is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Farmington, Connecticut
- UConn Health — Farmington, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Hardeep Singh, M.D. — UConn Health
- Study coordinator: Hardeep Singh, MD
- Email: uconnorthopaedics@uchc.edu
- Phone: 860-679-6883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.