Clinical trial NCT06774066: High Volume Injection in Mid Portion AChilles Tendinopathy
Official title: High Volume Image Guided Injection in Mid Portion Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mid-Portion Achilles Tendinopathy
Keywords: Achilles tendinopathy
high volume saline injection
mechanical properties
free tendon
Lead sponsor: University of Malta
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mechanical properties of tendon - dynamic stiffness
timeFrame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
measure: The Victorian Institute of Sport Assessment - Achilles
timeFrame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
Secondary outcomes:
measure: Single heel raises
timeFrame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
measure: Ultrasonography
timeFrame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
measure: Tampa Scale of Kinesiophobia
timeFrame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
measure: Global scale of change
timeFrame: This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.
Other outcomes:
measure: Use of other co-interventions
timeFrame: This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.
measure: Adherence to exercises
timeFrame: This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.
measure: Exiting interview on patient satisfaction
timeFrame: This outcome will be measured at the end of the trial after 12 weeks.
Locations:
city: Imsida
country: Malta
facility: Mater Dei Hospital
Study officials:
affiliation: University of Malta
name: Tiziana Mifsud
role: PRINCIPAL_INVESTIGATOR
References: