Achilles Injuries TendonNCT07483320
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
A study testing Platelet Rich Plasma and Extracorporeal Shockwave Therapy in people with Achilles Injuries Tendon and Achilles Tendinopathy (AT), run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Injuries Tendon, Achilles Tendinopathy (AT), Achilles Tendinitis, Left Leg
- What is being tested?
- Platelet Rich Plasma and Extracorporeal Shockwave Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Diagnosis of unilateral midportion Achilles tendinopathy
- Symptoms present for more than 3 months
- VISA-A score <80 at baseline
- Pre-injury physical activity level ≥3 on the Physical Activity Scale
- Ability to participate in rehabilitation program
Who cannot join
- Symptoms present for less than 3 months
- Prior PRP injection or ESWT treatment to the Achilles tendon within 3 months
- Other lower extremity musculoskeletal injury affecting function
- Symptomatic arthritis affecting the ankle or foot
- Rheumatologic disease or connective tissue disorder
- Coagulopathy or anticoagulant therapy affecting platelet function
Show all 10Show fewer
- Neuropathy affecting pain perception
- Known cardiac condition contraindicating treatment
- Poorly controlled diabetes (HbA1c >9.0)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Spaulding Cambridge Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: A Randomized Controlled Trial Evaluating the Influence of Physical Therapy, Shockwave Therapy, Platelet Rich Plasma or Combined Treatment in the Management of Midportion Achilles Tendinopathy
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.
Read the detailed description
Midportion Achilles tendinopathy (Mid-AT) is characterized by pain, stiffness, and impaired function resulting from a failed tendon healing response. Progressive loading exercise programs such as the Silbernagel protocol represent the current standard treatment and provide meaningful improvement for many individuals. However, approximately 40% of patients continue to experience persistent symptoms despite rehabilitation.
Extracorporeal shockwave therapy (ESWT) and platelet-rich plasma (PRP) injections are increasingly used in clinical practice to address refractory symptoms. ESWT is proposed to stimulate tissue healing through mechanotransduction and has demonstrated improved outcomes when combined with exercise therapy in some studies. PRP contains concentrated autologous growth factors that may enhance tendon healing through stimulation of extracellular matrix production, angiogenesis, and collagen synthesis.
Despite increasing clinical use, there remains limited evidence evaluating the comparative or combined effects of PRP and ESWT in the treatment of Achilles tendinopathy. Furthermore, few trials have evaluated these therapies within a standardized rehabilitation framework.
The purpose of this randomized controlled trial is to evaluate the effectiveness of exercise therapy alone compared with exercise therapy combined with PRP injection, ESWT, or both interventions in individuals with chronic midportion Achilles tendinopathy. Participants will be randomized to one of four treatment groups: exercise with sham procedures (control), exercise plus PRP injection, exercise plus ESWT, or exercise combined with PRP and ESWT. Participants will be followed for six months to evaluate patient-reported outcomes, tendon structure using ultrasound, physical function testing, and gait biomechanics. This study aims to determine whether PRP, ESWT, or the combination of both treatments provide superior functional recovery compared with exercise-based rehabilitation alone.
- Conditions
- Achilles Injuries Tendon, Achilles Tendinopathy (AT), Achilles Tendinitis, Left Leg, Achilles Tendinitis, Right Leg, Achilles Tendon Pain, Achilles Tendonitis
- Being tested
- Platelet Rich Plasma, Extracorporeal Shockwave Therapy, Sham PRP, Sham ESWT
- Keywords
- PRP, platelet rich plasma, extracorporeal shockwave, focus shockwave, radial pressure waves, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaDevice
Participants randomized to PRP will receive a single ultrasound-guided injection of approximately 3 mL of neutrophil-poor platelet-rich plasma derived from autologous blood. Blood will be processed to concentrate platelets and the PRP will be injected adjacent to the Achilles tendon at the site of maximal pain.
Extracorporeal Shockwave TherapyDevice
Participants randomized to ESWT will receive three weekly treatment sessions. Focused shockwave therapy will deliver approximately 2000 shocks with gradual energy escalation, followed by radial shockwave therapy delivering approximately 3000 pulses to the Achilles tendon and 3000 pulses to surrounding musculature.
Sham PRPDevice
A needle will be inserted but no injection will occur around the Achilles tendon
Sham ESWTDevice
Both focused shockwave and radial pressure wave will be in contact with the skin, but the devices will not be active to deliver energy. An audio recording will provide noises similar to the machines operating.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave | Sham comparator | 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. Receives: Device: Sham PRP; Device: Sham ESWT |
| Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave | Experimental | 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. Receives: Device: Platelet Rich Plasma; Device: Sham ESWT |
| Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP | Experimental | 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. Receives: Device: Extracorporeal Shockwave Therapy; Device: Sham PRP |
| Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy | Experimental | 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. Receives: Device: Platelet Rich Plasma; Device: Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Victorian Institute of Sport Assessment-Achilles (VISA-A)
The VISA-A is an eight item questionnaire measures Achilles tendon pain and function, with scores ranging from 0 to 100 (higher scores indicating better function).
Measured: baseline, 8 weeks, 4 months, 6 months
Secondary outcomes (6)
PROMIS-29 Patient Reported Outcomes
Change in PROMIS-29 domain scores evaluating physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and social participation.
Measured: Baseline, 8 weeks, 4 months, 6 months
University of Wisconsin Running Injury and Recovery Index (UWRI)
Running-specific recovery and functional ability measure for participants who run regularly.
Measured: baseline, 8 weeks, 4 months, 6 months
Ultrasound Tendon Cross-Sectional Area
Changes in Achilles tendon cross-sectional area measured by ultrasound at the site of maximal tendon thickness.
Measured: baseline, 6 months
Heel Rise Test Endurance
Total number of single-leg heel raises performed until fatigue or inability to maintain pace or same height.
Measured: baseline, 6 months
Hop Test Pain
Pain rating following completion of a standardized single-leg hop test of 20 repetitions.
Measured: baseline, 6 months
Gait Biomechanics
Changes in lower extremity biomechanics and symmetry during walking and running assessed using motion capture and instrumented treadmill analysis in those who elect to complete biomechanical assessment.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Injuries TendonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional study with option to receive additional treatment at 6 months for those assigned to sham PRP and sham ESWT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Storz Medical AG, Foundation for Physical Medicine and Rehabilitation
- Responsible party
- Principal investigator, Adam Tenforde, Spaulding Rehabilitation Hospital
- Investigators
- Adam S. Tenforde, MD, Principal investigator, Spaulding Rehabiltaition Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483320
- Sponsor's protocol ID
- 2025P002308
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: No identifiable information will be shared outside Mass General Brigham. We will consider publishing a limited deidentified data set at time of publication of our findings.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Influence of Physical Therapy, Shockwave Therapy, Platelet Rich Plasma or Combined Treatment in the Management of Midportion Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT07483320
- Acronym / sponsor ID
- 2025P002308
- Conditions
- Achilles Injuries Tendon, Achilles Tendinopathy (AT), Achilles Tendinitis, Left Leg, Achilles Tendinitis, Right Leg, Achilles Tendon Pain, Achilles Tendonitis
- Keywords
- PRP, platelet rich plasma, extracorporeal shockwave, focus shockwave, radial pressure waves, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Storz Medical AG, Foundation for Physical Medicine and Rehabilitation
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Midportion Achilles tendinopathy (Mid-AT) is characterized by pain, stiffness, and impaired function resulting from a failed tendon healing response. Progressive loading exercise programs such as the Silbernagel protocol represent the current standard treatment and provide meaningful improvement for many individuals. However, approximately 40% of patients continue to experience persistent symptoms despite rehabilitation.
Extracorporeal shockwave therapy (ESWT) and platelet-rich plasma (PRP) injections are increasingly used in clinical practice to address refractory symptoms. ESWT is proposed to stimulate tissue healing through mechanotransduction and has demonstrated improved outcomes when combined with exercise therapy in some studies. PRP contains concentrated autologous growth factors that may enhance tendon healing through stimulation of extracellular matrix production, angiogenesis, and collagen synthesis.
Despite increasing clinical use, there remains limited evidence evaluating the comparative or combined effects of PRP and ESWT in the treatment of Achilles tendinopathy. Furthermore, few trials have evaluated these therapies within a standardized rehabilitation framework.
The purpose of this randomized controlled trial is to evaluate the effectiveness of exercise therapy alone compared with exercise therapy combined with PRP injection, ESWT, or both interventions in individuals with chronic midportion Achilles tendinopathy. Participants will be randomized to one of four treatment groups: exercise with sham procedures (control), exercise plus PRP injection, exercise plus ESWT, or exercise combined with PRP and ESWT. Participants will be followed for six months to evaluate patient-reported outcomes, tendon structure using ultrasound, physical function testing, and gait biomechanics. This study aims to determine whether PRP, ESWT, or the combination of both treatments provide superior functional recovery compared with exercise-based rehabilitation alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Interventional study with option to receive additional treatment at 6 months for those assigned to sham PRP and sham ESWT
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave | Sham comparator | Device: Sham PRP, Device: Sham ESWTA 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. |
| Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave | Experimental | Device: Platelet Rich Plasma, Device: Sham ESWTPRP 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. |
| Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP | Experimental | Device: Extracorporeal Shockwave Therapy, Device: Sham PRPSham 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. |
| Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy | Experimental | Device: Platelet Rich Plasma, Device: Extracorporeal Shockwave TherapyPRP 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 years
- Diagnosis of unilateral midportion Achilles tendinopathy
- Symptoms present for more than 3 months
- VISA-A score <80 at baseline
- Pre-injury physical activity level ≥3 on the Physical Activity Scale
Key exclusion criteria (10 listed)
- Symptoms present for less than 3 months
- Prior PRP injection or ESWT treatment to the Achilles tendon within 3 months
- Other lower extremity musculoskeletal injury affecting function
- Symptomatic arthritis affecting the ankle or foot
- Rheumatologic disease or connective tissue disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich PlasmaParticipants randomized to PRP will receive a single ultrasound-guided injection of approximately 3 mL of neutrophil-poor platelet-rich plasma derived from autologous blood. Blood will be processed to concentrate platelets and the PRP will be injected adjacent to the Achilles tendon at the site of maximal pain. | Device | Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave, Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy |
| Extracorporeal Shockwave TherapyParticipants randomized to ESWT will receive three weekly treatment sessions. Focused shockwave therapy will deliver approximately 2000 shocks with gradual energy escalation, followed by radial shockwave therapy delivering approximately 3000 pulses to the Achilles tendon and 3000 pulses to surrounding musculature. | Device | Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP, Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy |
| Sham PRPA needle will be inserted but no injection will occur around the Achilles tendon | Device | Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave, Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP |
| Sham ESWTBoth focused shockwave and radial pressure wave will be in contact with the skin, but the devices will not be active to deliver energy. An audio recording will provide noises similar to the machines operating. | Device | Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave, Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave |
Primary outcome
Victorian Institute of Sport Assessment-Achilles (VISA-A)
Time frame: baseline, 8 weeks, 4 months, 6 months
The VISA-A is an eight item questionnaire measures Achilles tendon pain and function, with scores ranging from 0 to 100 (higher scores indicating better function).
6 secondary outcomes
PROMIS-29 Patient Reported Outcomes
Time frame: Baseline, 8 weeks, 4 months, 6 months
University of Wisconsin Running Injury and Recovery Index (UWRI)
Time frame: baseline, 8 weeks, 4 months, 6 months
Ultrasound Tendon Cross-Sectional Area
Time frame: baseline, 6 months
Heel Rise Test Endurance
Time frame: baseline, 6 months
Hop Test Pain
Time frame: baseline, 6 months
Gait Biomechanics
Time frame: baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided. No identifiable information will be shared outside Mass General Brigham. We will consider publishing a limited deidentified data set at time of publication of our findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam S. Tenforde, MD principal investigator
Spaulding Rehabiltaition Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma and Extracorporeal Shockwave Therapy in people with Achilles Injuries Tendon and Achilles Tendinopathy (AT), run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sydney Karnovsky, MD ((862) 216-8050, skarnovsky@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Victorian Institute of Sport Assessment-Achilles (VISA-A) (time frame: baseline, 8 weeks, 4 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.