High Volume Injection in Mid Portion AChilles Tendinopathy

NCT06774066 | Completed

• 1 other identifier: V:15062020 7806
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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?

Conditions

Mid-Portion Achilles Tendinopathy

Keywords

Achilles tendinopathy; high volume saline injection; mechanical properties; free tendon

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Single heel raises

  This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.

• Ultrasonography

  This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.

• Tampa Scale of Kinesiophobia

  This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.

• Global scale of change

  This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.

Other Outcomes (3)

• Use of other co-interventions

  This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.

• Adherence to exercises

  This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.

• Exiting interview on patient satisfaction

  This outcome will be measured at the end of the trial after 12 weeks.

Study Arms (2)

Progressive rehabilitation exercise group

ACTIVE COMPARATOR

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

High volume image guided injection + progressive rehabilitation exercise group

EXPERIMENTAL

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: High volume image guided injection; Other: Progressive rehabilitation exercise programme

Interventions

High volume image guided injection 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.

High volume image guided injection + progressive rehabilitation exercise group

Progressive rehabilitation exercise programme 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; Progressive rehabilitation exercise group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malta: lead

Study Sites (1)

Mater Dei Hospital

Msida, Malta

Location

Study Officials

• Tiziana Mifsud

  University of Malta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician and the clinician assessing mechanical and morphological changes will be blinded to treatment allocation, which will reduce observer bias in the evaluation of outcomes. Additionally, ultrasonographic images will be taken and saved for offline analysis without any identification of the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: November 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-01

Locations

MA (1)