Shockwave Therapy for Knee Arthritis

(PTOA Knee Trial)

Overseen By Adam S Tenforde, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 3 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for current or former athletes who had ACL reconstruction surgery over a year ago and now have knee osteoarthritis. Participants should be diagnosed with post-traumatic knee OA to qualify.

Inclusion Criteria

My main source of pain is my knee.

I have been diagnosed with mild to moderate knee arthritis confirmed by X-rays.

No clear contraindication to complete protocol including mechanical symptoms which would limit ability to complete the study

Exclusion Criteria

I am not currently taking any oral steroids or anti-inflammatory medications.

I have a chronic condition like severe asthma or an immune disorder that affects my inflammation.

I have a nerve condition that changes how I feel pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including biomechanical assessment, thermal imaging, bioimpedance, knee range of motion, quadriceps strength, and MRI of the knee.

1-2 weeks

2-3 visits (in-person)

Treatment

Participants receive ESWT or sham ESWT treatment over three sessions, with blood draws and biomarker analysis.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with repeat assessments at 8 weeks and 4 months.

4 months

2 visits (in-person), 1 visit (virtual)

Optional Cross-over

Participants in the sham ESWT group have the option to cross-over and receive ESWT treatment.

4 months

Treatment Details

Interventions

• Extracorporeal Shockwave Therapy

Trial Overview The study investigates the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, and joint health in knees affected by osteoarthritis compared to a sham treatment.

Participant Groups

Group I: Treatment Group: ESWT Arm Experimental Treatment 1 Intervention

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.

Group II: Control Group: Sham ESWT Arm Placebo Group 1 Intervention

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.

Extracorporeal Shockwave Therapy is already approved in United States for the following indications:

Approved in United States as ESWT for:

• Chronic plantar fasciitis
• Lateral epicondylitis of the elbow

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+