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.
Age 18-65 years
Diagnosis of unilateral midportion Achilles tendinopathy
Symptoms present for more than 3 months
VISA-A score <80 at baseline
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
Parallel
Platelet Rich Plasma
DeviceParticipants 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 Therapy
DeviceParticipants 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 PRP
DeviceA needle will be inserted but no injection will occur around the Achilles tendon
Sham ESWT
DeviceBoth 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.
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).
PROMIS-29 Patient Reported Outcomes
Change in PROMIS-29 domain scores evaluating physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and social participation.
University of Wisconsin Running Injury and Recovery Index (UWRI)
Running-specific recovery and functional ability measure for participants who run regularly.
Ultrasound Tendon Cross-Sectional Area
Changes in Achilles tendon cross-sectional area measured by ultrasound at the site of maximal tendon thickness.
Heel Rise Test Endurance
Total number of single-leg heel raises performed until fatigue or inability to maintain pace or same height.
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Spaulding Rehabilitation Hospital
Lead sponsor
Storz Medical AG
Collaborator
Foundation for Physical Medicine and Rehabilitation
Collaborator
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