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Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy

Status: Recruiting

Location: See location...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 55

Healthy Volunteers: f

View:

• 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.

Locations

United States

Massachusetts

Spaulding Cambridge Hospital

RECRUITING

Cambridge

Contact Information

Primary

Adam S Tenforde, MD

atenforde@mgh.harvard.edu

(617) 952-6800

Time Frame

Start Date: 2025-04-01

Estimated Completion Date: 2026-09

Participants

Target number of participants: 70

Treatments

Sham_comparator: Control Group: Sham ESWT Arm

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.

Experimental: Treatment Group: ESWT Arm

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.

Related Therapeutic Areas

Arthritis

Osteoarthritis

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