Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:10 PM
Study NCT ID:
NCT07483320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional study with option to receive additional treatment at 6 months for those assigned to sham PRP and sham ESWT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-03-15', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Victorian Institute of Sport Assessment-Achilles (VISA-A)', 'timeFrame': 'baseline, 8 weeks, 4 months, 6 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'PROMIS-29 Patient Reported Outcomes', 'timeFrame': 'Baseline, 8 weeks, 4 months, 6 months', 'description': 'Change in PROMIS-29 domain scores evaluating physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and social participation.'}, {'measure': 'University of Wisconsin Running Injury and Recovery Index (UWRI)', 'timeFrame': 'baseline, 8 weeks, 4 months, 6 months', 'description': 'Running-specific recovery and functional ability measure for participants who run regularly.'}, {'measure': 'Ultrasound Tendon Cross-Sectional Area', 'timeFrame': 'baseline, 6 months', 'description': 'Changes in Achilles tendon cross-sectional area measured by ultrasound at the site of maximal tendon thickness.'}, {'measure': 'Heel Rise Test Endurance', 'timeFrame': 'baseline, 6 months', 'description': 'Total number of single-leg heel raises performed until fatigue or inability to maintain pace or same height.'}, {'measure': 'Hop Test Pain', 'timeFrame': 'baseline, 6 months', 'description': 'Pain rating following completion of a standardized single-leg hop test of 20 repetitions.'}, {'measure': 'Gait Biomechanics', 'timeFrame': 'baseline, 6 months', 'description': 'Changes in lower extremity biomechanics and symmetry during walking and running assessed using motion capture and instrumented treadmill analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PRP', 'platelet rich plasma', 'extracorporeal shockwave', 'focus shockwave', 'radial pressure waves', 'rehabilitation'], 'conditions': ['Achilles Injuries Tendon', 'Achilles Tendinopathy (AT)', 'Achilles Tendinitis, Left Leg', 'Achilles Tendinitis, Right Leg', 'Achilles Tendon Pain', 'Achilles Tendonitis']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': '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.\n\nExtracorporeal 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.\n\nDespite 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of unilateral midportion Achilles tendinopathy\n* Symptoms present for more than 3 months\n* VISA-A score \\<80 at baseline\n* Pre-injury physical activity level ≥3 on the Physical Activity Scale\n* Ability to participate in rehabilitation program\n\nExclusion Criteria:\n\n* Symptoms present for less than 3 months\n* Prior PRP injection or ESWT treatment to the Achilles tendon within 3 months\n* Other lower extremity musculoskeletal injury affecting function\n* Symptomatic arthritis affecting the ankle or foot\n* Rheumatologic disease or connective tissue disorder\n* Coagulopathy or anticoagulant therapy affecting platelet function\n* Neuropathy affecting pain perception\n* Known cardiac condition contraindicating treatment\n* Poorly controlled diabetes (HbA1c \\>9.0)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07483320', 'briefTitle': 'Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2025P002308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave', 'description': '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.', 'interventionNames': ['Device: Sham PRP', 'Device: Sham ESWT']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave', 'description': '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.', 'interventionNames': ['Device: Platelet Rich Plasma', 'Device: Sham ESWT']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP', 'description': '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.', 'interventionNames': ['Device: Extracorporeal Shockwave Therapy', 'Device: Sham PRP']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy', 'description': '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.', 'interventionNames': ['Device: Platelet Rich Plasma', 'Device: Extracorporeal Shockwave Therapy']}], 'interventions': [{'name': 'Platelet Rich Plasma', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave', 'Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy']}, {'name': 'Extracorporeal Shockwave Therapy', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP', 'Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy']}, {'name': 'Sham PRP', 'type': 'DEVICE', 'description': 'A needle will be inserted but no injection will occur around the Achilles tendon', 'armGroupLabels': ['Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave', 'Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP']}, {'name': 'Sham ESWT', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave', 'Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Cambridge Hospital', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'centralContacts': [{'name': 'Sydney Karnovsky, MD', 'role': 'CONTACT', 'email': 'skarnovsky@mgb.org', 'phone': '(862) 216-8050'}], 'overallOfficials': [{'name': 'Adam S. Tenforde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spaulding Rehabiltaition Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Storz Medical AG', 'class': 'INDUSTRY'}, {'name': 'Plymouth Medical', 'class': 'UNKNOWN'}, {'name': 'Foundation for Physical Medicine and Rehabilitation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Harvard Medical School', 'investigatorFullName': 'Adam Tenforde', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}