High Volume Injection in Mid Portion AChilles Tendinopathy

Not Applicable

Completed

• Conditions: Mid-Portion Achilles Tendinopathy

• Registration Number: NCT06774066
• Lead Sponsor: University of Malta

Brief 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.

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mechanical properties of tendon - dynamic stiffness	This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.	Dynamic stiffness measured using the MyotonPRO at the middle part of the free tendon and over the soleus tendinous junction as identified by ultrasonography in both short and long axis.
The Victorian Institute of Sport Assessment - Achilles	This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.	The questionnaire encompasses three key domains: pain, functional capacity, and activity level, thereby providing a comprehensive assessment of the patient's condition from their perspective. The Victorian Institute of Sport Assessment - Achilles score ranges from 0 to 100, with 0 indicating no activity and maximum pain, while a score of 100 represents the highest level of activity with no pain experienced. A minimal detectable change of 12 points was considered for the change to be clinically significant (McCormack et al., 2015).

Secondary Outcome Measures

Name	Time	Method
Single heel raises	This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.	The single-leg heel raise test was utilised to assess the strength and endurance of the plantar flexor muscles. Participants were instructed to lift their heel to the maximum possible height for up to 25 repetitions or until the onset of discomfort or pain, whichever occurred first. A metronome was used to provide auditory feedback to help maintain a consistent pace throughout the test. A successful trial of the single-leg heel raise (SLHR) was recorded if the patient was able to maintain the set pace with the metronome (60 bpm/30 repetitions per minute) and demonstrated proper plantarflexion height and alignment. The trial was considered invalid if the patient compensated by: * flexing the knee,; * using a hip propulsive strategy,; * or losing vertical displacement due to trunk flexion (Hébert-Losier et al., 2022; Hebert-Losier et al., 2017).
Ultrasonography	This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.	Ultrasonography was employed to assess secondary outcome measures, including cross-sectional area, tendon length, tendon thickness, and neovascularisation.
Tampa Scale of Kinesiophobia	This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.	Tampa Scale of Kinesiophobia will be used to assess patients' perspectives on their condition and the avoidance and fear of movement.
Global scale of change	This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.	The global rating of change consists of a single question addressing the overall change in Achilles tendon symptoms from the start of treatment to the follow-up appointment, focusing on the patient's self-perceived change in health status.

Trial Locations

Locations (1)

Mater Dei Hospital; 🇲🇹 Imsida, Malta