Shockwave Therapy + PRP for Achilles Tendonitis

SK
Overseen BySydney Karnovsky, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Spaulding Rehabilitation Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Midportion Achilles tendinopathy is a common cause of pain and functional limitation in both athletes and the general population. Progressive tendon loading programs are considered first-line treatment but do not lead to satisfactory outcomes in all patients. Extracorporeal shockwave therapy (ESWT) and platelet-rich plasma (PRP) injections are commonly used interventions for refractory symptoms, yet evidence supporting their combined use is limited particularly in treating Achilles tendon disorders.

This randomized controlled trial will evaluate the effectiveness of a standardized exercise program alone or in combination with PRP injection, ESWT, or both therapies in active adults with midportion Achilles tendinopathy. Participants will be randomized to one of four treatment groups and followed for six months. The primary outcome will assess changes in Achilles tendon symptoms and function using the Victorian Institute of Sport Assessment-Achilles (VISA-A) score. Secondary outcomes will include patient-reported outcomes, physical function testing, ultrasound tendon structure measures, and gait biomechanics.

Who Is on the Research Team?

AS

Adam S. Tenforde, MD

Principal Investigator

Spaulding Rehabiltaition Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 65 years old.
I have Achilles tendinopathy in one leg, in the middle part of the tendon.
I have had symptoms for more than 3 months.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a standardized exercise program alone or in combination with PRP injection, ESWT, or both therapies

6 months
Multiple visits for treatment sessions and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Follow-up assessments at baseline, 8 weeks, 4 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Extracorporeal Shockwave Therapy
  • Platelet Rich Plasma

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave TherapyExperimental Treatment2 Interventions
Group II: Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRPExperimental Treatment2 Interventions
Group III: Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham ShockwaveExperimental Treatment2 Interventions
Group IV: Arm 1 - Control Exercise Therapy + Sham PRP + Sham ShockwavePlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials
143
Recruited
11,200+

Storz Medical AG

Industry Sponsor

Trials
9
Recruited
540+

Foundation for Physical Medicine and Rehabilitation

Collaborator

Trials
7
Recruited
240+

Plymouth Medical

Collaborator