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Search / Trial NCT06774066

High Volume Injection in Mid Portion AChilles Tendinopathy

Launched by UNIVERSITY OF MALTA · Jan 8, 2025

Trial Information

Current as of June 24, 2025

Completed

Keywords

Achilles Tendinopathy High Volume Saline Injection Mechanical Properties Free Tendon

ClinConnect Summary

This clinical trial is studying a new treatment for people suffering from mid-portion Achilles tendinopathy, which is pain in the middle part of the Achilles tendon at the back of the ankle. The researchers want to find out if a specific treatment called high-volume image-guided injection, combined with rehabilitation exercises, works better than regular care for improving tendon health and reducing pain. The trial will also look at changes in the tendon’s structure after treatment over a period of three months.

To be eligible for the trial, participants should be between 18 and 75 years old and have had persistent Achilles tendon pain for more than three months despite previous treatments like physiotherapy. The study is looking for individuals who have certain ultrasound signs of tendinopathy, such as a thickened tendon or changes in its appearance. Participants can expect to receive either the new injection treatment or standard rehabilitation exercises, and they will be closely monitored throughout the study to assess their progress and improvement. This trial is currently recruiting participants, and all genders are welcome to join.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Participants with mid-portion Achilles tendon pain in one or both legs. In bilateral symptoms, the most symptomatic leg will be considered for assessing the intervention or standard progressive rehabilitation exercise programme.
  • Participants with chronic Achilles tendinopathy for more than three months who had previously undergone physiotherapy and exercise rehabilitation but experienced no improvement or continued to suffer from severe pain.
  • Having one or more ultrasonography characteristics of mid-portion tendinopathy including thickened tendon, neovascularisation, hypoechogenic areas or loss of fibrillar homogeneity.
  • Exclusion Criteria:
  • History of previous Achilles tendon rupture or surgically repaired tendons.
  • Presentation of insertional Achilles tendinopathy or concurrent pain at both the insertional and mid-portion of the Achilles tendon at the start of the study.
  • Presence of neurological or metabolic conditions known to affect tendon health

About University Of Malta

The University of Malta, a premier institution for higher education and research in the Mediterranean region, is committed to advancing medical knowledge and improving healthcare outcomes through innovative clinical trials. With a multidisciplinary approach, the University leverages its extensive expertise in various fields, including medicine, pharmacy, and biomedical sciences, to conduct rigorous and ethically sound research. By fostering collaboration among academic, clinical, and industry partners, the University of Malta aims to translate scientific discoveries into practical applications, ultimately enhancing patient care and contributing to the global body of medical knowledge.

Locations

Imsida, , Malta

Patients applied

0 patients applied

Trial Officials

Tiziana Mifsud

Principal Investigator

University of Malta

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported