Muscle WeaknessPhase 4NCT05929755
Depo-Medrol on Psoas After LLIF
A Phase 4 study testing Depo-Medrol and Gel-Flow NT in people with Muscle Weakness and Pain, Postoperative, run by Hardeep Singh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Muscle Weakness, Pain, Postoperative, Paresthesia
- What is being tested?
- Depo-Medrol and Gel-Flow NT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2023to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Scoliosis >10°
- Spondylolisthesis >Grade 1
- Flatback deformity
- Patients with insulin dependent diabetes
- Patients with >3 levels of fusion
- Alternative interbodies
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UConn Health
Farmington, Connecticut, 06030
Study Coordinator, uconnorthopaedics@uchc.edu
Hardeep Singh, M.D.
About this study
Official title: Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness
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.
Read the detailed description
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
- Conditions
- Muscle Weakness, Pain, Postoperative, Paresthesia, Pain, Muscle
- Being tested
- Depo-Medrol, Gel-Flow NT
- Keywords
- lateral lumbar interbody fusion, LLIF, Depo-Medrol, corticosteroid, lumbar spine, psoas muscle, postoperative hip flexor weakness, postoperative thigh pain, postoperative thigh numbness
- Medical subject headings
- Muscle Weakness, Pain, Postoperative, Paresthesia, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo-MedrolDrug
steroid
Gel-Flow NTDrug
hemostatic agent
| Study group | Role | What they receive |
|---|---|---|
| Control group (standard care) | Placebo comparator | 1 cc gel foam powder mixed with thrombin Receives: Drug: Gel-Flow NT |
| Test group (standard care + study intervention) | Experimental | 1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol Receives: Drug: Depo-Medrol; Drug: Gel-Flow NT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"?
Measured: 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"?
Measured: 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"?
Measured: 12 weeks following surgery
Secondary outcomes (6)
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
Measured: 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
- 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
Measured: 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."
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start12 May 2023
- Primary completionAug 2025 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hardeep Singh
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Minimally Invasive Spine Surgery
- Responsible party
- Sponsor-investigator, Hardeep Singh, UConn Health
- Investigators
- Hardeep Singh, M.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929755
- Sponsor's protocol ID
- 23-090-2
- Status last verified
- Jul 2025
- First submitted
- 26 May 2023
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness
- ClinicalTrials.gov ID
- NCT05929755
- Acronym / sponsor ID
- 23-090-2
- Conditions
- Muscle Weakness, Pain, Postoperative, Paresthesia, Pain, Muscle
- Keywords
- lateral lumbar interbody fusion, LLIF, Depo-Medrol, corticosteroid, lumbar spine, psoas muscle, postoperative hip flexor weakness, postoperative thigh pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hardeep SinghUniversity, hospital or other
- Collaborators
- Society for Minimally Invasive Spine Surgery
- Study start
- 12 May 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (standard care) | Placebo comparator | Drug: Gel-Flow NT1 cc gel foam powder mixed with thrombin |
| Test group (standard care + study intervention) | Experimental | Drug: Depo-Medrol, Drug: Gel-Flow NT1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- Scoliosis >10°
- Spondylolisthesis >Grade 1
- Flatback deformity
- Patients with insulin dependent diabetes
- Patients with >3 levels of fusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depo-Medrolsteroid | Drug | Test group (standard care + study intervention) |
| Gel-Flow NThemostatic agent | Drug | Control group (standard care), Test group (standard care + study intervention) |
Primary outcome
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"?
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"?
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"?
6 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.
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.
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)
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)
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
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.
Time frame: 1 year and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hardeep Singh, M.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Depo-Medrol and Gel-Flow NT in people with Muscle Weakness and Pain, Postoperative, run by Hardeep Singh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hardeep Singh, MD (860-679-6883, uconnorthopaedics@uchc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 2-3 weeks following surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.