High Volume Injection in Mid Portion AChilles Tendinopathy (HighIMPACT)

High Volume Image Guided Injection in Mid Portion Achilles Tendinopathy

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?

Study Overview

• Status: Completed
• Conditions: Mid-Portion Achilles Tendinopathy
• Intervention / Treatment: Other: Progressive rehabilitation exercise programme; Other: High volume image guided injection

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malta
  • Imsida, Malta
    • Mater Dei Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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)
Experimental: 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.	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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical properties of tendon - dynamic stiffness	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.	This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
The Victorian Institute of Sport Assessment - Achilles	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).	This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single heel raises	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).	This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
Ultrasonography	Ultrasonography was employed to assess secondary outcome measures, including cross-sectional area, tendon length, tendon thickness, and neovascularisation.	This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
Tampa Scale of Kinesiophobia	Tampa Scale of Kinesiophobia will be used to assess patients' perspectives on their condition and the avoidance and fear of movement.	This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
Global scale of change	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.	This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of other co-interventions	Patients were asked to report any co-interventions undertaken during the 3-month period	This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.
Adherence to exercises	Participants self-reported their adherence using a 4-point Likert scale, which categorised adherence into four distinct levels: very good adherence, indicating consistent engagement with the prescribed exercise regimen; good adherence, reflecting regular participation but not on a daily basis; poor adherence, suggesting infrequent engagement; and very poor adherence, denoting minimal or no participation in the prescribed exercises. Participants were informed about the option to maintain a logbook of exercises performed; however, this was not mandatory.	This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.
Exiting interview on patient satisfaction	An exiting satisfactory semi structured interview was conducted with willing participants to explore patients perspective on the effectiveness of their treatment and elaborate on their results.	This outcome will be measured at the end of the trial after 12 weeks.

Collaborators and Investigators

• Sponsor: University of Malta
• Collaborators: University of Malta
• Investigators: Principal Investigator: Tiziana Mifsud, University of Malta

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Achilles tendinopathy; free tendon; mechanical properties; high volume saline injection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: V:15062020 7806

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No