Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age14-65
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged 14-65

undergoing ACL Reconstruction.

Disqualifiers

contraindications to corticosteroids

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methyl Prednisolone (MP)

    Drug

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

  • Standard Post-Operative Pain Control

    Drug

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

  • Surgeon's Standard ACL Postoperative Regimen

    Combination product

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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Treatment GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Average Narcotic Consumption Post Surgery

Paricipants will be assessed on the average amount of pain medication taken on a daily basis.

Time frame
Daily up to 6 days and 1 week post op
2

Percentage of overall Pain Post Operatively

Participants 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.

Time frame
Daily for 7 days post op

Secondary outcomes

1

Change in Range of Motion

Participants 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.

Time frame
baseline, 2 weeks, 6 weeks and 3 months

Other outcomes

Sponsors and contacts

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