Shockwave Therapy + PRP for Achilles Tendonitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of different treatments for individuals with midportion Achilles tendinopathy, a condition that causes pain and movement issues in the Achilles tendon. The trial tests a combination of exercise, platelet-rich plasma (PRP) injections, and extracorporeal shockwave therapy to determine which combination is most beneficial. Participants will be divided into four groups to experience these treatments in various combinations. It is suitable for those who have experienced tendon pain for over three months and remain active but still face challenges with daily tasks. As an unphased trial, this study provides a unique opportunity to explore innovative treatment combinations for enhancing daily life.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulant therapy (blood thinners), you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that extracorporeal shockwave therapy (ESWT) is a safe treatment for Achilles tendinopathy. Studies have found that ESWT reduces pain and improves movement in patients. This treatment uses sound waves to aid tendon healing and has no major reported side effects.
Similarly, platelet-rich plasma (PRP) injections are safe for treating tendon problems. PRP uses a patient's own blood to accelerate healing. Research indicates that PRP does not cause infections, blood clots, or tendon tears. These findings suggest that both ESWT and PRP are well-tolerated by patients and carry minimal risks.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining Extracorporeal Shockwave Therapy (ESWT) with Platelet-Rich Plasma (PRP) for Achilles tendonitis because these treatments could offer new mechanisms of healing. Unlike traditional options like physical therapy, rest, or anti-inflammatory medications, ESWT delivers targeted acoustic waves to stimulate tissue regeneration, while PRP uses components from the patient's own blood to enhance healing and reduce inflammation. This dual approach aims to accelerate recovery and improve outcomes by directly addressing the underlying issues in the tendon, which could lead to more effective and faster relief for patients compared to current standard treatments.
What evidence suggests that this trial's treatments could be effective for Achilles tendonitis?
Research has shown that extracorporeal shockwave therapy (ESWT) can reduce pain and improve movement in people with midportion Achilles tendinopathy. Studies have found that about 54.9% of people experience success with ESWT for this condition. In this trial, one group of participants will receive ESWT alongside exercise therapy. Conversely, results for platelet-rich plasma (PRP) injections are mixed; some studies have found short-term benefits that often don't last. Another group in this trial will receive PRP combined with exercise therapy. When used together, ESWT and PRP still require more solid evidence to confirm their combined effectiveness for Achilles tendonitis.14567
Who Is on the Research Team?
Adam S. Tenforde, MD
Principal Investigator
Spaulding Rehabiltaition Hospital
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 who have had pain in one Achilles tendon (midportion) for over 3 months, are physically active, and have moderate to severe symptoms. Participants must be able to join a rehab program.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a standardized exercise program alone or in combination with PRP injection, ESWT, or both therapies
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Extracorporeal Shockwave Therapy
- Platelet Rich Plasma
Trial Overview
The study compares four treatments: exercise alone, exercise plus platelet-rich plasma (PRP) injection, exercise plus shockwave therapy (ESWT), or both PRP and ESWT together. Participants are randomly assigned to one group and followed for six months.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
PRP will be administered followed by three sessions of ESWT. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
Sham PRP will be delivered. Three sessions of ESWT will be delivered to the Achilles tendon. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
PRP will be delivered around the tendon, sham ESWT will be issued. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
A sham PRP injection will be performed where the needle breaks the skin but does not fenestrate the tendon. The sham ESWT will include radial pressure waves and focused shockwaves delivered without the device turned on to deliver energy and audio recording. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spaulding Rehabilitation Hospital
Lead Sponsor
Storz Medical AG
Industry Sponsor
Foundation for Physical Medicine and Rehabilitation
Collaborator
Plymouth Medical
Collaborator
Citations
The Effectiveness of Extracorporeal Shockwave Therapy for ...
This review suggests that ESWT is a safe and effective modality for treating midportion Achilles tendinopathy as it reduces pain and improves function.
Therapeutic effects following extracorporeal shock wave ...
In a study that analyzed 355 patients after shock wave treatment for the management of tendinopathies, Notarnicola et al. reported a success rate of only 54.9% ...
Effectiveness of extracorporeal shockwave therapy versus ...
Our study revealed that both ESWT and conventional physical therapy recorded highly significant VAS reduction and highly significant improvement ...
Long-Term Outcome and Factors Affecting Prognosis of ... - PMC
The shorter duration of 'post-treatment soreness after first ESWT' was identified as the only positive prognostic parameter in achieving long-term success.
Clinical Trial to Evaluate the Adjuvant Effect of Shock Wave ...
If, on the one hand, the results for non-insertional tendinopathy were encouraging, 82% of them being duly successful, the insertional tendinopathy, on the ...
Efficacy and safety of extracorporeal shock wave therapy for ...
ESWT is effective and safe. An optimum treatment protocol for ESWT appears to be three treatment sessions at 1-week intervals, with 2000 impulses per session ...
Extracorporeal shockwave therapy versus sham ... - PMC
Extracorporeal shockwave therapy (ESWT) is widely used, but its true effectiveness and safety for chronic Achilles tendinopathy remains debated.
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