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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.

Interventions

High volume image guided injectionOther

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 programmeOther

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

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

High Volume Injection in Mid Portion AChilles Tendinopathy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Other Outcomes (3)

Study Arms (2)

Progressive rehabilitation exercise group

High volume image guided injection + progressive rehabilitation exercise group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Other Outcomes (3)

Study Arms (2)

Progressive rehabilitation exercise group

High volume image guided injection + progressive rehabilitation exercise group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations