Shockwave Therapy for Knee Arthritis (PTOA Knee Trial)

Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Spaulding Rehabilitation Hospital

No Placebo Group

Approved in 1 jurisdiction

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

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

I had ACL surgery with a specific technique and now have arthritis in that knee.

I am between 18 and 55 years old.

My knee pain score is less than 72.

Exclusion Criteria

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

I have neuropathy that affects my ability to feel pain.

I have been cancer-free for at least five years.

I have had shock wave therapy for knee arthritis with the study's devices.

I have heart conditions that could be worsened by shockwave therapy.

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

I have had knee injections in the last 3 months.

I do not have a pacemaker, bone screws, or metal implants that prevent MRI scans or EWST.

I am pregnant or planning to become pregnant.

I have had surgery on both ACLs or had ACL revision surgery.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Group: ESWT ArmExperimental Treatment1 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 ArmPlacebo Group1 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: