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

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT07483320
Status
Not Yet Recruiting

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Conditions

  • Achilles Injuries Tendon
  • Achilles Tendinitis, Left Leg
  • Achilles Tendinitis, Right Leg
  • Achilles Tendinopathy (AT)
  • Achilles Tendon Pain
  • Achilles Tendonitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Platelet Rich Plasma — DEVICE
    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 Therapy — DEVICE
    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 PRP — DEVICE
    A needle will be inserted but no injection will occur around the Achilles tendon
  • Sham ESWT — DEVICE
    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 Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
May 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave
    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.
  • Experimental: Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave
    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.
  • Experimental: Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP
    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.
  • Experimental: Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy
    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.

Primary Outcome Measure

Victorian Institute of Sport Assessment-Achilles (VISA-A) [ Time Frame: baseline, 8 weeks, 4 months, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Cambridge HospitalCambridgeMassachusetts02138-

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By research site
Spaulding Cambridge Hospital· Cambridge, MA

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