A Phase 4 interventional study of Depo-Medrol and Gel-Flow NT in Muscle Weakness, Pain, Postoperative and Paresthesia, sponsored by Hardeep Singh. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Hardeep Singh · Phase 4, Interventional, and Other
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.
Primary Objective and Outcome Measure:
Secondary Objectives and Outcome Measures:
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:
Ancillary Objectives and Outcome Measures:
Groups:
477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.
This study's planned enrollment of 80 is above the median of 44 across 362 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →This is the only study on the registry with Hardeep Singh as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 cc gel foam powder mixed with thrombin
Drug: Gel-Flow NT
1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol
Drug: Depo-Medrol · Drug: Gel-Flow NT
steroid
hemostatic agent
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
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
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
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
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
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
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
Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Sciatica Bothersomeness Index
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.
Time frame: 2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
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.
Fusion rate - Assessed with Flexion, Extension X-ray (screw loosening/fracture, instability) CT Scan if patient has a symptomatic (pain) pseudoarthrosis (lack of fusion)
Time frame: 1 year and 2 years
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Aug 2025, 27 months after the start.
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Studies of the drug tested here: Methylprednisolone Acetate