Mid-Portion Achilles TendinopathyHighIMPACTNCT06774066
High Volume Injection in Mid Portion AChilles Tendinopathy
A study testing High volume image guided injection and Progressive rehabilitation exercise programme in people with Mid-Portion Achilles Tendinopathy, run by University of Malta at 1 site in Malta.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mid-Portion Achilles Tendinopathy
- What is being tested?
- High volume image guided injection and Progressive rehabilitation exercise programme
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalta
- Study dates
- 1 Nov 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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
- Being tested
- High volume image guided injection, Progressive rehabilitation exercise programme
- Keywords
- Achilles tendinopathy, high volume saline injection, mechanical properties, free tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Progressive rehabilitation exercise programmeOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High volume image guided injection; Other: Progressive rehabilitation exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Nov 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid-Portion Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiziana Mifsud, University of Malta
- Investigators
- Tiziana Mifsud, Principal investigator, University of Malta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774066
- Sponsor's protocol ID
- V:15062020 7806
- Acronym
- HighIMPACT
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Volume Image Guided Injection in Mid Portion Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT06774066
- Acronym / sponsor ID
- HighIMPACT / V:15062020 7806
- Conditions
- Mid-Portion Achilles Tendinopathy
- Keywords
- Achilles tendinopathy, high volume saline injection, mechanical properties, free tendon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MaltaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive rehabilitation exercise group | Active comparator | Other: Progressive rehabilitation exercise programmeThis 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. |
| High volume image guided injection + progressive rehabilitation exercise group | Experimental | Other: High volume image guided injection, Other: Progressive rehabilitation exercise programmeThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High volume image guided injectionHigh 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. | Other | High volume image guided injection + progressive rehabilitation exercise group |
| Progressive rehabilitation exercise programmeA 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 + progressive rehabilitation exercise group, Progressive rehabilitation exercise group |
Primary outcome
Mechanical properties of tendon - dynamic stiffness
Time frame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
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.
The Victorian Institute of Sport Assessment - Achilles
Time frame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
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).
4 secondary outcomes
Single heel raises
Time frame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
Ultrasonography
Time frame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
Tampa Scale of Kinesiophobia
Time frame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.
Global scale of change
Time frame: This outcome will be measured after 2 weeks, after 6 weeks and after 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiziana Mifsud principal investigator
University of Malta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High volume image guided injection and Progressive rehabilitation exercise programme in people with Mid-Portion Achilles Tendinopathy, run by University of Malta at 1 site in Malta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malta. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical properties of tendon - dynamic stiffness (time frame: This outcome will be measured at baseline, after 2 weeks, after 6 weeks and after 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.