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Enrolling by Invitation

NCT Number: NCT07580157

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Focused Shockwave

Other

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 Shockwave

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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