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Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction

Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07605923
Enrollment
64
Registered
2026-05-26
Start date
2026-09-01
Completion date
2031-08-01
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Reconstruction

Keywords

ACL, Anterior Cruciate ligament reconstruction, postoperative pain, corticosteroid taper, methylprednisolone taper, multimodal pain protocol

Brief summary

Patients who are being seen for ACL tears will be approached in the UAB Orthopedic Clinic. Included patients will be those aged 14-65 undergoing ACL Reconstruction. Excluded patients will be those with contraindications to corticosteroids. If the patient meets the criteria and agrees to participate, then the consent form will be signed, and the patient will be enrolled. Enrolled patients will be randomized to one of two groups. Patients in the treatment group will receive a 4 mg oral 6-day methylprednisolone taper in addition to standard post-operative pain control. Patients in the control group will receive standard post-operative pain control. All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. Endpoints will include narcotic consumption assessed daily and at one week post-op through a patient self-reported diary. The VAS pain score will be collected each day for the first week. Secondary endpoints will include range of motion and patient-reported outcomes, including IKDC, KOOS Jr, Tegner Activity Scale, ACL-RSI, and PROMIS Global collected at baseline, 2 weeks, 6 weeks and 3 months. All outcomes will be collected through PatientIQ.

Interventions

Participants will receive 4mg oral tablet of methylprednisolone taper for 6 days after surgery.

DRUGStandard Post-Operative Pain Control

All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.

COMBINATION_PRODUCTSurgeon's Standard ACL Postoperative Regimen

All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* aged 14-65 * undergoing ACL Reconstruction.

Exclusion criteria

* contraindications to corticosteroids

Design outcomes

Primary

MeasureTime frameDescription
Average Narcotic Consumption Post SurgeryDaily up to 6 days and 1 week post opParicipants will be assessed on the average amount of pain medication taken on a daily basis.
Percentage of overall Pain Post OperativelyDaily for 7 days post opParticipants will be evaluated using the Visual Analogue Scale (VAS) for pain is a self-reported tool, typically a 10-cm horizontal line, anchored by "no pain" (0 cm) and "worst pain" (10 cm). Patients mark their pain level, offering a simple, sensitive, and highly subjective assessment for acute, chronic, or disease-specific pain.

Secondary

MeasureTime frameDescription
Change in Range of Motionbaseline, 2 weeks, 6 weeks and 3 monthsParticipants will be measured on their range of motion after surgery using a goniometer. An instrument used to measure joint angles (range of motion) in rehabilitation and physical therapy, or to determine precise angular positions in engineering and physics.

Countries

United States

Contacts

CONTACTAmit Momaya, MD
amomaya@uabmc.edu(205) 930-8339
CONTACTCrystal Taylor
crystalmtaylor@uabmc.edu205-807-4050
PRINCIPAL_INVESTIGATORAmit Momaya, MD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026