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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-6000 FSWT | Device | Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Change of initial values at 3 weeks follow up after last application (8th week). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change of the echostructure at 3 weeks follow up after last application (8th week). |
| Number of Participants With Increased Thickness of Achilles Tendon |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanislav Machač, Mgr., Ph.D. | University Hospital Motol and 2nd Faculty of Medicine, Charles University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Motol and 2nd Faculty of Medicine, Charles University | Prague | Czechia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group (A) | Group of assigned patients with Achilles tendinopathy which were treated by focused extracorporeal shockwave therapy once a week for 5 weeks. BTL-6000 FSWT: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300. |
| FG001 | Sham Group (B) | Group of assigned 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. BTL-6000 FSWT with sham applicator: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group (A) | 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. BTL-6000 FSWT: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | cm^2 | Change of initial values at 3 weeks follow up after last application (8th week). |
|
From baseline to 3 weeks follow up
All-Cause Mortality is not expected when applying the ESWT at Achilles tendon area and was not monitored/assessed. However, Serious, and Other (Not Including Serious) Adverse Events were monitored using simple questions to patients during and after the procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group (A) | Group of assigned patients with Achilles tendinopathy which were treated by focused extracorporeal shockwave therapy once a week for 5 weeks. BTL-6000 FSWT: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jakub Katolicky | Charles University, 2nd Faculty of Medicine | +420 739 081 676 | jakub@katolicky.eu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2021 | Apr 3, 2021 | Prot_SAP_000.pdf |
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Participants are divided into two groups - treatment and placebo.
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Participants don't know which group (either treatment or placebo) they are in.
| BTL-6000 FSWT with sham applicator | Device | Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission. |
|
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. |
| 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. | 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. | 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. | Change of initial values at 3 weeks follow up after last application (8th week). |
| Sham Group (B) |
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. BTL-6000 FSWT with sham applicator: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Duration of difficulties | Simple question about duration of experienced difficulties until the baseline assessment. The result answer is presented in whole number of months. A number equal to 12 months refers the duration of the difficulties equal to or longer than 1 year. | Mean | Standard Deviation | months |
|
| Baseline maximal pain | Using Numeric Rating Scale in points reaching 0-10. Higher points indicate worse pain. | Mean | Standard Deviation | units on a scale |
|
| Baseline VISA-A score | Using the Victorian Institute of Sports Assessment - Achilles questionaire. Higher score indicates better condition. | Mean | Standard Deviation | score on a scale |
|
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.
BTL-6000 FSWT with sham applicator: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission.
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Change in maximum pain in the timeframe of the last application (5th week) |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Change in maximum pain at 3 weeks follow up after last application (8th week). |
|
|
|
|
| Primary | Change of Ankle Dorsiflexion Range of Motion | Measured using weight-bearing lunge test in cm. | Posted | Mean | Standard Deviation | cm | Change of initial values at 3 weeks follow up after last application (8th week). |
|
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|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Change of the echostructure at 3 weeks follow up after last application (8th week). |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Change of the tendon continuity at 3 weeks follow up after last application (8th week). |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change of initial values at 3 weeks follow up after last application (8th week). |
|
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| Secondary | 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. | In the Group A, this test was performed by all participants in initial and final examination. In the Group B, this test was performed by all participants in initial examination and by 8 (of 9) participants in final examination. One patient was not able to perform this test in final examination due to the associated health complications (not caused by the used intervention). | Posted | Mean | Standard Deviation | repetitions | Change of initial values at 3 weeks follow up after last application (8th week) |
|
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|
| Secondary | 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. | In the Group A, this test was performed by all participants in initial and final examination. In the Group B, this test was performed by all participants in initial examination and by 8 (of 9) participants in final examination. One patient was not able to perform this test in final examination due to the associated health complications (not caused by the used intervention). | Posted | Mean | Standard Deviation | repetitions | Change of initial values at 3 weeks follow up after last application (8th week). |
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| 0 |
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| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Sham Group (B) | Group of assigned 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. BTL-6000 FSWT with sham applicator: Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission. | 0 | 0 | 0 | 9 | 0 | 9 |
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