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

May 6, 2026 updated by: Joshua M. Romero, Mayo Clinic

Focused Shockwave For Anterior Knee Pain Following Anterior Cruciate Ligament Reconstruction (ACL-R)

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Focused shockwave
Focused shockwave (FSW) will be applied to the autograft harvest site for 3 consecutive weekly sessions.
Other: Focused Shockwave
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 Comparator: Sham focused shockwave
The sham focused shockwave will be applied to the autograft harvest site for 3 consecutive weekly sessions.
Other: Sham Focused Shockwave
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score
Time Frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months
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.
Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in The Kujala Anterior Knee Pain Scale (AKPS) score
Time Frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months
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.
Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months
Tegner activity scale score
Time Frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months
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.
Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months
Change in Visual Analog Scale (VAS) pain score
Time Frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months
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.
Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Joshua M. Romero, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 26, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-001203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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