A Study Of Focused Shockwave For Anterior Knee Pain Following Anterior Cruciate Ligament Reconstruction

N/AEnrolling By InvitationNCT07580157

Mayo Clinic20 enrolled

Overview

The purpose of this study is to investigate whether Focused Shockwave (FSW) therapy reduces anterior knee pain following anterior cruciate ligament reconstruction (ACL-R) with bone-patellar tendon-bone (BTB) or quadriceps tendon (QT) autografts.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Focused ShockwaveOTHER

Focused shockwave will be administered to the autograft harvest site following anterior cruciate ligament reconstruction (ACL-R) using either bone-patellar tendon-bone (BTB) or quadriceps tendon (QT) autografts

Sham Focused ShockwaveOTHER

The applicator tip will be placed on the skin with sterile gel and an audio recording of the focused shockwave will be turned on to mimic the sound of the machine.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults ≥18 years of age. * Have undergone primary ACL-R with BTB or QT autograft. * Have not previously undergone FSW or radial pressure wave (RPW) in the past for any indication * Must speak English * Capacity to provide consent Exclusion Criteria: * Pregnant or breastfeeding. * Revision ACL-R. * History of previous ipsilateral knee surgery. * Multi-ligament knee injury requiring surgical intervention beyond ACL. o Not including concomitant meniscal or chondral injuries addressed at the time of surgery. * History of deep vein thrombosis. * Active infection at or near the harvest site.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score

The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation is a patient-reported outcome measure focusing on knee symptoms, function, and sports activity. It is scored on a 0-100 scale, where higher scores indicate higher function and lower symptoms.

Time frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months

Secondary Outcomes

Change in The Kujala Anterior Knee Pain Scale (AKPS) score

The Kujala Score or Anterior Knee Pain Scale (AKPS) is a 13-item a patient-reported questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The AKPS is graded on a scale of 0 to 100, with higher scores indicating better function and less pain.

Time frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months

Tegner activity scale score

The Tegner Activity Scale (TAS) is a 2 item patient-reported questionnaire. Questions are answered with 0-10 rating system, used to standardize the measurement of work and sporting activity levels. Subjects select the highest activity level they can perform, where 0 represents disability and 10 represents national elite competitive sports.

Time frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months

Change in Visual Analog Scale (VAS) pain score

The Visual Analog Scale (VAS) is a 1-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 10, lower scores indicating lower pain and higher scores indicating greater pain.

Time frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months

Data from ClinicalTrials.gov

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