70 Participants Needed

Shockwave Therapy for Knee Arthritis

(PTOA Knee Trial)

AS
Overseen ByAdam S Tenforde, MD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Spaulding Rehabilitation Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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
See 3 more

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.
See 9 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Group: ESWT ArmExperimental Treatment1 Intervention
Group II: Control Group: Sham ESWT ArmPlacebo Group1 Intervention

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

🇺🇸
Approved in United States as ESWT for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials
143
Recruited
11,200+
Unbiased ResultsWe believe in providing patients with all the options.
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