High Volume Injection in Mid Portion AChilles Tendinopathy

NCT ID: NCT06774066

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-02-28

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.

Conditions

Mid-Portion Achilles Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Progressive rehabilitation exercise group

This group will receive the standard first-line treatment, which consists of education and progressive exercise-based rehabilitation tailored to the patient. The exercises will 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) where the pain is allowed to reach a level of 5 on the Visual Analog Scale during exercises, provided that it diminishes immediately after the session. This pain should subside by the following morning and the pain and stiffness in the Achilles tendon are not permitted to increase from one day to the next.

Group Type: ACTIVE_COMPARATOR

Progressive rehabilitation exercise programme

Intervention Type: OTHER

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)

High volume image guided injection + progressive rehabilitation exercise group

The intervention group will be given the high volume image-guided injection only once at the beginning of the trial, together with the same education and progressive exercise-based rehabilitation as the control group. The participants will be informed to rest for the first three days and then start slowly the progressive exercises on the same principle as for the control group.

Group Type: EXPERIMENTAL

High volume image guided injection

Intervention Type: OTHER

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.

Progressive rehabilitation exercise programme

Intervention Type: OTHER

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)

Interventions

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.

Intervention Type: 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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malta

OTHER

Sponsor Role: lead

Responsible Party

Tiziana Mifsud

PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tiziana Mifsud

Role: PRINCIPAL_INVESTIGATOR

University of Malta

Locations

Mater Dei Hospital

Msida, , Malta

Countries

Malta

Other Identifiers

V:15062020 7806

Identifier Type: -

Identifier Source: org_study_id