Achilles TendinopathyNCT04780919
Ultrasound-Monitored Changes in Achilles Tendinopathy After Extracorporeal Shock Wave Therapy
A study testing BTL-6000 FSWT in people with Achilles Tendinopathy, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- BTL-6000 FSWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2021to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- the patient complains about Achilles tendon pain, which limits (at least partially) his quality of life during daily activities or sport, and this condition would be referred as a tendinopathy
- the patient's other leg is asymptomatic
- the patient is not aware of the symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
- the patient has no previous experience with extracorporeal shockwave therapy treatment
Who cannot join
- the patient has condition which is contraindication for extracorporeal shock wave therapy treatment
- the patient had symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Motol and 2nd Faculty of Medicine, Charles University
Prague
About this study
Official title: The Ultrasound-Monitored Changes in Achilles Tendinopathy After Focused Extracorporeal Shock Wave Therapy - a Randomized Sham-Controlled Trial
This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.
Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the first week, there will be a clinical examination by a physiotherapist, an ultrasonographic examination, and the patient will complete a VISA-A questionnaire. At the end of the examination, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.
Read the detailed description
This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.
Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the initial session, there will be a clinical examination by a physiotherapist, which includes case history questions, measuring range of motion (measured by weight-bearing lunge test), functional loading tests (1-leg heel rise test, 1-leg hop test) and an ultrasonographic examination (tendon cross section area and width at the maximal tendon antero-posterior width place). In addition, the patient will complete a VISA-A questionnaire. At the end of the initial session, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.
- Conditions
- Achilles Tendinopathy
- Being tested
- BTL-6000 FSWT, BTL-6000 FSWT with sham applicator
- Keywords
- Extracorporeal Shock Wave Therapy, Achilles Tendinopathy, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-6000 FSWTDevice
Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.
BTL-6000 FSWT with sham applicatorDevice
Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group (A) | Experimental | Group of patients with Achilles tendinopathy which are treated by focused extracorporeal shockwave therapy once a week for 5 weeks. ESWT parameters: 0,12 mJ/mm2, 10 Hz, 1300 shocks. Receives: Device: BTL-6000 FSWT |
| Sham Group (B) | Sham comparator | Group of patients with Achilles tendinopathy in which sham extracorporeal shockwave therapy is applied once a week for 5 weeks. Total applications are 5, applicated weekly. Sham ESWT parameters are same as in Group A (0,12 mJ/mm2, 10 Hz, 1300 shocks) but with modified applicator which does not allow wave transmission. Receives: Device: BTL-6000 FSWT with sham applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cross-sectional Area at the Place of Maximum Tendon Width
Measured by measuring tools in ultrasound machine in cm2. In linear view is selected maximal width place, then the position of ultrasound head is rotated to horizontal view and in this view cross section area is measured.
Measured: Change of initial values at 3 weeks follow up after last application (8th week).
Change in Maximum Pain in the Achilles Tendon Area
Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.
Measured: Change in maximum pain in the timeframe of the last application (5th week)
Change in Maximum Pain in the Achilles Tendon Area (Follow up)
Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.
Measured: Change in maximum pain at 3 weeks follow up after last application (8th week).
Change of Ankle Dorsiflexion Range of Motion
Measured using weight-bearing lunge test in cm.
Measured: Change of initial values at 3 weeks follow up after last application (8th week).
Secondary outcomes (5)
Number of Participants With Hypoechogenic Areas
Echostructure is evaluated visually by investigator using musculoskeletal ultrasound machine. Patients who have a hypoechogenic areas in the tendon are counted.
Measured: Change of the echostructure at 3 weeks follow up after last application (8th week).
Number of Participants With Increased Thickness of Achilles Tendon
The Achilles tendon continuity in evaluated visually by investigator using musculoskeletal ultrasound machine. Patients who have a visually significant increased thickness of tendon will be counted.
Measured: Change of the tendon continuity at 3 weeks follow up after last application (8th week).
Change in VISA-A Questionnaire Score
The VISA-A questionnaire is standardized questionnaire for patients with Achilles tendinopathy. The results are recorded in points (0-100 points). The higher score indicates patients better condition.
Measured: Change of initial values at 3 weeks follow up after last application (8th week).
Change in Single Leg Heel Rise Test
Patient performs as many heel rises using only one leg as possible in 30 seconds or until first sign of pain in Achilles tendon area.
Measured: Change of initial values at 3 weeks follow up after last application (8th week)
Change in Single Leg Hop Test
Patient performs as many hops on one leg as possible in 30 seconds or until first sign of pain in Achilles tendon area.
Measured: Change of initial values at 3 weeks follow up after last application (8th week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Feb 2021
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Model description
- Participants are divided into two groups - treatment and placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislav Machač, Ph.D, Charles University, Czech Republic
- Investigators
- Stanislav Machač, Mgr., Ph.D., Principal investigator, University Hospital Motol and 2nd Faculty of Medicine, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780919
- Sponsor's protocol ID
- EK- 1/21
- Status last verified
- Jun 2021
- First submitted
- 24 Feb 2021
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ultrasound-Monitored Changes in Achilles Tendinopathy After Focused Extracorporeal Shock Wave Therapy - a Randomized Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT04780919
- Acronym / sponsor ID
- EK- 1/21
- Conditions
- Achilles Tendinopathy
- Keywords
- Extracorporeal Shock Wave Therapy, Achilles Tendinopathy, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Posted 2 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.
Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the first week, there will be a clinical examination by a physiotherapist, an ultrasonographic examination, and the patient will complete a VISA-A questionnaire. At the end of the examination, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.
Detailed description
This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.
Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the initial session, there will be a clinical examination by a physiotherapist, which includes case history questions, measuring range of motion (measured by weight-bearing lunge test), functional loading tests (1-leg heel rise test, 1-leg hop test) and an ultrasonographic examination (tendon cross section area and width at the maximal tendon antero-posterior width place). In addition, the patient will complete a VISA-A questionnaire. At the end of the initial session, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are divided into two groups - treatment and placebo.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (A) | Experimental | Device: BTL-6000 FSWTGroup of patients with Achilles tendinopathy which are treated by focused extracorporeal shockwave therapy once a week for 5 weeks. ESWT parameters: 0,12 mJ/mm2, 10 Hz, 1300 shocks. |
| Sham Group (B) | Sham comparator | Device: BTL-6000 FSWT with sham applicatorGroup of patients with Achilles tendinopathy in which sham extracorporeal shockwave therapy is applied once a week for 5 weeks. Total applications are 5, applicated weekly. Sham ESWT parameters are same as in Group A (0,12 mJ/mm2, 10 Hz, 1300 shocks) but with modified applicator which does not allow wave transmission. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- the patient complains about Achilles tendon pain, which limits (at least partially) his quality of life during daily activities or sport, and this condition would be referred as a tendinopathy
- the patient's other leg is asymptomatic
- the patient is not aware of the symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
- the patient has no previous experience with extracorporeal shockwave therapy treatment
Key exclusion criteria (2 listed)
- the patient has condition which is contraindication for extracorporeal shock wave therapy treatment
- the patient had symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
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 |
|---|---|---|
| BTL-6000 FSWTIntensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300. | Device | Treatment Group (A) |
| BTL-6000 FSWT with sham applicatorIntensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission. | Device | Sham Group (B) |
Primary outcome
Change in Cross-sectional Area at the Place of Maximum Tendon Width
Time frame: Change of initial values at 3 weeks follow up after last application (8th week).
Measured by measuring tools in ultrasound machine in cm2. In linear view is selected maximal width place, then the position of ultrasound head is rotated to horizontal view and in this view cross section area is measured.
Change in Maximum Pain in the Achilles Tendon Area
Time frame: Change in maximum pain in the timeframe of the last application (5th week)
Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.
Change in Maximum Pain in the Achilles Tendon Area (Follow up)
Time frame: Change in maximum pain at 3 weeks follow up after last application (8th week).
Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.
Change of Ankle Dorsiflexion Range of Motion
Time frame: Change of initial values at 3 weeks follow up after last application (8th week).
Measured using weight-bearing lunge test in cm.
5 secondary outcomes
Number of Participants With Hypoechogenic Areas
Time frame: Change of the echostructure at 3 weeks follow up after last application (8th week).
Number of Participants With Increased Thickness of Achilles Tendon
Time frame: Change of the tendon continuity at 3 weeks follow up after last application (8th week).
Change in VISA-A Questionnaire Score
Time frame: Change of initial values at 3 weeks follow up after last application (8th week).
Change in Single Leg Heel Rise Test
Time frame: Change of initial values at 3 weeks follow up after last application (8th week)
Change in Single Leg Hop Test
Time frame: Change of initial values at 3 weeks follow up after last application (8th week).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Stanislav Machač, Mgr., Ph.D. principal investigator
University Hospital Motol and 2nd Faculty of Medicine, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTL-6000 FSWT in people with Achilles Tendinopathy, run by University Hospital, Motol at 1 site in Czechia.
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 4 inclusion and 2 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 28 Jun 2021. 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 Czechia. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Cross-sectional Area at the Place of Maximum Tendon Width (time frame: Change of initial values at 3 weeks follow up after last application (8th week).). The study lists 4 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 28 Jun 2021.