NCT06774066

High Volume Injection in Mid Portion AChilles Tendinopathy

High Volume Image Guided Injection in Mid Portion Achilles Tendinopathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Malta · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This prospective randomised clinical trial aims to evaluate the effectiveness of treatment for mid-portion Achilles tendinopathy in a real-world clinical setting, minimising the excessive control typically associated with explanatory studies. The primary focus is to assess the mechanical effects of high-volume image-guided injection in combination with rehabilitation exercises over three months. Additionally, the study will determine the overall clinical improvement in participants. The main questions it aims to answer are: Is high-volume image-guided injection treatment superior to the usual care in treating mid-portion Achilles tendinopathy? Do mechanical and morphological properties of the tendon change after the treatment?

Detailed description

The objectives of this trial are to * Evaluate the effectiveness of high-volume image-guided injection combined with rehabilitation exercises in improving symptoms and functionality in patients with mid-portion Achilles tendinopathy. * Measure changes in the mechanical properties of the Achilles tendon, including dynamic stiffness, as well as morphological characteristics such as thickness, cross-sectional area, and neovascularisation following treatment. * Assess patient-reported outcomes related to pain, disability and function using validated questionnaires * Explore participants' experiences and perceptions regarding their symptoms and the trial itself.

Conditions

• Mid-Portion Achilles Tendinopathy

Interventions

Type	Name	Description
OTHER	High volume image guided injection	High volume image guided injection consists of 9.5ml of bupivacaine, 0.5ml 20mg Depo-medrol, and 40ml of injectable saline. This procedure will be commenced with a thorough disinfection of the injection site. The mid-portion of the Achilles tendon will then be imaged in the short axis to obtain a cross-sectional view of the tendon, alongside the anterior region, including Kager's fat pad, particularly in areas of maximal pain and increased neovascularity. Once the needle is correctly positioned, the high-volume fluid will be infiltrated under pressure, with ultrasound guidance confirming the reduction or complete disappearance of neovascularisation.
OTHER	Progressive rehabilitation exercise programme	A comprehensive explanation of the progressive exercise program will be provided to patients, along with a detailed booklet that includes four tiers of exercises, ranging from the easiest to the most challenging. Exercises include several eccentrics, isometrics and heavy slow resistance exercises. These exercises are to be performed once a day and the intensity and number of repetitions will be based on the patients' status. The progressive exercise program is designed to avoid exacerbating the patient's symptoms; however, some pain is permitted during the sessions following the pain monitoring model proposed by Thomee (1997)

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2025-01-14
• Last updated: 2025-03-30

Locations

1 site across 1 country: Malta