An interventional study of High volume image guided injection and Progressive rehabilitation exercise programme in Mid-Portion Achilles Tendinopathy, sponsored by University of Malta. Completed at 1 site in Malta. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by University of Malta · Not applicable, Interventional, and Treatment
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?
The objectives of this trial are to
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
This study's enrollment of 20 is below the median of 48 across 332 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →University of Malta is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
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)
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.
Time frame: 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).
Time frame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.
Use of other co-interventions
Patients were asked to report any co-interventions undertaken during the 3-month period
Time frame: 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.
Time frame: 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.
Time frame: This outcome will be measured at the end of the trial after 12 weeks.
Ran from Nov 2023 to primary completion in Feb 2025, 15 months.
Of 174 non-industry interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 15 months is below that.
Counting every sponsor, half of 183 studies reached it within 20 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University of Malta