Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy

NCT06686680 | Recruiting FDA Device

• 2 other identifiers: 2024P0003762024A002554
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study is recruiting current or former athletes who had ACL reconstruction surgery over a year ago and have been diagnosed with knee osteoarthritis (OA). We are doing the research to investigate the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, knee range of motion and strength, inflammation, and joint structure and integrity of the knee.

Conditions

ACL Injuries; Post-Traumatic; Knee Osteoarthristis

Keywords

Post-traumatic Knee Osteoarthritis; Extracorporeal shockwave therapy; acl

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  The KOOS is is a 42-item survey with 5 subscales designed to measure patient health, symptoms, and functionality of the knee. It is scored from 0-100, with higher score correlated with better function.

  From baseline to 4-month follow up with intermediate measure at 8 weeks

Secondary Outcomes (19)

• Biomarkers of oxidative stress and inflammation

  Baseline, at each of the three treatment sessions and at 4 months

• Biomechanics

  Baseline and 4 months

• Knee range of motion

  Baseline and 4 months

• Quadriceps strength and power

  Baseline and 4 months

• Quantitative Sensory Testing (Pain Pressure Threshold)

  Baseline and 4 months

Study Arms (2)

Control Group: Sham ESWT Arm

SHAM COMPARATOR

All participants will review the exercise program prior to randomization and receiving sham ESWT treatment. The standard operating procedures for ESWT will be followed and will include review of procedure protocol and post-procedure care. Participants will come into the office for three treatment visits separated by seven days +/- 7 days to account for ongoing challenges for respiratory illness and scheduling/traveling conflicts. After collecting baseline variables and after blood is drawn, they will receive sham ESWT administered by trained research personnel, using the OrthoPlus Ultra 100/radial D-Actor and Duolith SD1 T-Top focused shockwave devices. The device will be placed on the same landmarks as that of the ESWT treatment group; however, no shockwaves will be administered; rather, an audio recording that mimics the sound of shockwave will be played. A curtain will obscure participants from viewing their knee and the device to blind them from treatment they are receiving.

Device: Sham Comparator

Treatment Group: ESWT Arm

EXPERIMENTAL

All participants will review the exercise program prior to randomization and receiving treatment. Participants in the ESWT group will receive ESWT. The standard operating procedures for ESWT will be followed and will include review of procedure protocol and post-procedure care. Radial and focused shockwave will be delivered to the knee and lower leg landmarks. The energy settings that will be used are consistent with mild to moderate ESWT which are commonly used in clinical practice to treat knee OA. During the ESWT treatment, a curtain will obscure participants from viewing their leg to blind them from treatment they are receiving. Standard protocol for the ESWT procedure will be followed, including safety assessment and monitoring. Additionally, the patient will be prescribed a post-ESWT exercise protocol that is part of the standard of care, which will be reviewed prior to first treatment and before treatment allocation is decided to minimize risk of bias.

Device: extracorporeal shockwave therapy (ESWT)

Interventions

Sham Comparator DEVICE

All participants will review the exercise program prior to randomization and receiving sham ESWT treatment. The standard operating procedures for ESWT will be followed and will include review of procedure protocol and post-procedure care. Participants will come into the office for three treatment visits separated by seven days +/- 7 day. Sham ESWT will administered by trained research personnel, using the OrthoPlus Ultra 100/radial D-Actor and Duolith SD1 T-Top focused shockwave devices. The device will be placed on the same landmarks as that of the ESWT treatment group; however, no shockwaves will be administered; rather, an audio recording that mimics the sound of shockwave will be played. A curtain will obscure participants from viewing their knee and the device to blind them from treatment they are receiving.

Control Group: Sham ESWT Arm

extracorporeal shockwave therapy (ESWT) DEVICE

Participants will receive ESWT administered by research personnel, using the OrthoPlus Ultra 100/radial D-Actor and Duolith SD1 T-top focus.Radial pressure waves will be applied using the Extracorporeal Pressure Activation Treatment (EPAT) device. For the anterior knee, patella tendon, vastus lateralis, and vastus medialis, treatment will aim for 1500 strikes at induction dose of 1.5 bars and titrating up by 0.5 bars to 3 bars and this will be performed to participant tolerance to pain, as pain is experienced due to clinical focusing technique which is standard of care in delivering effective treatment. For the calf muscles, the patient will be positioned prone and a similar protocol of starting at 1.5 and titrating up as tolerated to 3 bars. Focused shockwave therapy will be applied for 1000 shocks to four anatomical locations for a total of 4000 shocks. Each site will receive 1000 shocks: medial and lateral tibial plateau and medial and lateral femoral condyle.

Treatment Group: ESWT Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Previous ACL reconstruction using an autograft or allograft in the knee with PTOA
• Minimum of one year following ACL reconstruction surgery
• Between ages of 18 and 55
• No clear contraindication to complete protocol including mechanical symptoms which would limit ability to complete the study
• Score on KOOS for 2 of 4 domains (pain, symptoms, activities of daily living (ADL), quality of life (QOL)) of 85 or lower
• Primary pain is coming from the knee
• Diagnosis of PTOA based on clinical diagnosis and confirmation with radiographic evidence by a medical professional prior to study enrollment. If individuals have suspected OA based on impairments such as pain, they must have a score on KOOS for 2 of 4 domains (pain, symptoms, activities of daily living (ADL), quality of life (QOL)) of 85 or lower to participate in the study.

You may not qualify if:

• Have previously received injections to the knee joint within the past 3 months
• Women who are pregnant or those who are planning to become pregnant. This is due to the fact that pregnancy will reduce participants activity after the treatment and the safety concerns related to shockwave treatment. - Participants with neuropathy affecting sensation to pain
• Participants with a known underlying cardiac disease that could be affected by shockwave therapy
• Neuropathy diagnosis that can affect response to pain
• No active use of oral steroids or anti-inflammatories at the time of enrollment
• Have bilateral ACL injury or reconstruction surgery, or have had ACL revision surgery
• No active malignancy and at least five years in remission
• Previous ESWT treatment using study treatment devices for management of knee osteoarthritis
• Have a pacemaker, bone screws, or any other metal implants that would prohibit participation in an MRI scan or EWST
• Non-English speaking individuals

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Cambridge Hospital

Cambridge, Massachusetts, 02138, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Adam S Tenforde, MD

CONTACT

(617) 952-6800; atenforde@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Parallel study model of randomization to placebo or true shockwave. Elective cross-over design after each participant completes the study who was assigned placebo can receive shockwave.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 13, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)