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Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Nov 30, 2027 → Mar 15, 2028
See other at-risk trials from Spaulding Rehabilitation Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Aug 1, 2026 to Oct 15, 2026
    • Primary completion pushed from Nov 30, 2027 to Mar 15, 2028
    • Study completion pushed from May 30, 2028 to Sep 30, 2028
    • Eligibility criteria expanded, about 16 words
  2. Start date: Jun 1, 2026 to Aug 1, 2026v3
  3. Start date: Apr 1, 2026 to Jun 1, 2026v2 Show 4 more changesShow less
    • Primary completion pushed from Sep 30, 2027 to Nov 30, 2027
    • Study completion pushed from Mar 30, 2028 to May 30, 2028
    • Secondary endpoints: details revised at 1 of 6 entries
    • Collaborators: 3 to 2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07483320
Lead Sponsor Spaulding Rehabilitation Hospital
Collaborators: Storz Medical AG, Foundation for Physical Medicine and Rehabilitation
Conditions
(from sponsor)		 Achilles Injuries Tendon, Achilles Tendinopathy (AT), Achilles Tendinitis, Left Leg, Achilles Tendinitis, Right Leg, Achilles Tendon Pain, Achilles Tendonitis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov