Insertional Achilles TendinopathyPhase 4NCT06384859
Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy
A Phase 4 study testing ESWT and PRP in people with Insertional Achilles Tendinopathy, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insertional Achilles Tendinopathy
- What is being tested?
- ESWT and PRP
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2024to 1 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with insertional Achilles tendinopathy
- Had symptom more than 6 months
- Failed other standard conservative treatment (rest, medication, activity modification, stretching exercise, and heel lift orthosis)
Who cannot join
- Receive corticosteroid injection at the Achilles insertion
- History of infection around ankle and heel
- Has neurological deficit
- Has a contraindication for ESWT(hemophilia, coagulopathy or foot and ankle malignancy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Ramathibodi hospital
Ratchathewi, Bangkok, 10400
Prapan Wongrungrote, MD, +66 0810688654, prapanw197@gmail.com
Sukij Laohajaroensombat, MD, +66 022011589, sukij.lah@mahidol.ac.th
About this study
The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:
Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?
Read more
Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.
Participants will:
- Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks
- Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score
- Conditions
- Insertional Achilles Tendinopathy
- Being tested
- ESWT, PRP
- Keywords
- chronic insertional Achilles tendinopathy, extracorporeal shockwave therapy, platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWTDevice
Receive ESWT once a week for 4 weeks
PRPBiological
Receive PRP injection at week 5
| Study group | Role | What they receive |
|---|---|---|
| ESWT + PRP | Experimental | Receive ESWT once a week for 4 weeks and PRP injection at a week later Receives: Device: ESWT; Biological: PRP |
| ESWT | Active comparator | Receive ESWT once a week for 4 weeks Receives: Device: ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual Analogue Scale
Measured: 6 week, 3 months, 6 months and 1 year after treatment
Secondary outcomes (3)
VAS-FA
Visual analogue scale foot and ankle
Measured: 6 week, 3 months, 6 months and 1 year after treatment
FFI
Foot functional index
Measured: 6 week, 3 months, 6 months and 1 year after treatment
FAAM
Foot and Ankle Ability Measure
Measured: 6 week, 3 months, 6 months and 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insertional Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384859
- Sponsor's protocol ID
- Pending
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT06384859
- Acronym / sponsor ID
- Pending
- Conditions
- Insertional Achilles Tendinopathy
- Keywords
- chronic insertional Achilles tendinopathy, extracorporeal shockwave therapy, platelet rich plasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 25 Apr 2024 (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.
The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:
Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?
Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.
Participants will:
- Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks
- Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT + PRP | Experimental | Device: ESWT, Biological: PRPReceive ESWT once a week for 4 weeks and PRP injection at a week later |
| ESWT | Active comparator | Device: ESWTReceive ESWT once a week for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with insertional Achilles tendinopathy
- Had symptom more than 6 months
- Failed other standard conservative treatment (rest, medication, activity modification, stretching exercise, and heel lift orthosis)
Key exclusion criteria (4 listed)
- Receive corticosteroid injection at the Achilles insertion
- History of infection around ankle and heel
- Has neurological deficit
- Has a contraindication for ESWT(hemophilia, coagulopathy or foot and ankle malignancy)
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 |
|---|---|---|
| ESWTReceive ESWT once a week for 4 weeks | Device | ESWT, ESWT + PRP |
| PRPReceive PRP injection at week 5 | Biological | ESWT + PRP |
Primary outcome
VAS
Time frame: 6 week, 3 months, 6 months and 1 year after treatment
Visual Analogue Scale
3 secondary outcomes
VAS-FA
Time frame: 6 week, 3 months, 6 months and 1 year after treatment
FFI
Time frame: 6 week, 3 months, 6 months and 1 year after treatment
FAAM
Time frame: 6 week, 3 months, 6 months and 1 year after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: Yes
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Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
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Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
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Augmenting Standard Rehabilitation With Blood Flow Restriction for Chronic Achilles Tendinopathy
Achilles Tendinopathy (AT)
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Achilles Tendinopathy; the Effect of Shockwave Treatment
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ESWT and PRP in people with Insertional Achilles Tendinopathy, run by Mahidol University at 1 site in Thailand.
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 4 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: opening soon, as of the sponsor's last update on 25 Apr 2024. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: 6 week, 3 months, 6 months and 1 year after treatment). 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 25 Apr 2024.