Trial Outcomes & Findings for Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy (NCT NCT05702918)
NCT ID: NCT05702918
Last Updated: 2026-01-14
Results Overview
Peak Spatial Frequency Radius (PSFR) was assessed using spatial frequency analysis (SFA) software applied to standardized B-mode ultrasound images of the Achilles tendon. Ultrasound images were acquired in a long-axis using predefined machine settings. The image was saved and exported for subsequent analysis. In the SFA software, the region corresponding to the site of maximal tendon pathology was selected, and PSFR values (mm-¹) were calculated. PSFR values were recorded at baseline and at the 26-week follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Values at baseline and week 26.
Results posted on
2026-01-14
Participant Flow
Participant milestones
| Measure |
Group A - ESWT + Exercise
Participants in group A will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
In addition, participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy will be set to 0.10-0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 shocks are applied from all three sides (medial, lateral, dorsal). The set values will not change throughout the research. These parameters were selected in accordance to ISMST guidelines.
|
Group B - Exercise
Participants in group B will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Group A - ESWT + Exercise
Participants in group A will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
In addition, participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy will be set to 0.10-0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 shocks are applied from all three sides (medial, lateral, dorsal). The set values will not change throughout the research. These parameters were selected in accordance to ISMST guidelines.
|
Group B - Exercise
Participants in group B will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Unrelated injury
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A - ESWT + Exercise
n=21 Participants
Participants in group A will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
In addition, participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy will be set to 0.10-0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 shocks are applied from all three sides (medial, lateral, dorsal). The set values will not change throughout the research. These parameters were selected in accordance to ISMST guidelines.
|
Group B - Exercise
n=20 Participants
Participants in group B will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 11.7 • n=21 Participants
|
32.8 years
STANDARD_DEVIATION 11.8 • n=20 Participants
|
33.1 years
STANDARD_DEVIATION 11.6 • n=41 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=21 Participants
|
9 Participants
n=20 Participants
|
16 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=21 Participants
|
11 Participants
n=20 Participants
|
25 Participants
n=41 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
24.7 kg/m^2
STANDARD_DEVIATION 5.1 • n=21 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 4.4 • n=20 Participants
|
24.9 kg/m^2
STANDARD_DEVIATION 4.8 • n=41 Participants
|
PRIMARY outcome
Timeframe: Values at baseline and week 26.Peak Spatial Frequency Radius (PSFR) was assessed using spatial frequency analysis (SFA) software applied to standardized B-mode ultrasound images of the Achilles tendon. Ultrasound images were acquired in a long-axis using predefined machine settings. The image was saved and exported for subsequent analysis. In the SFA software, the region corresponding to the site of maximal tendon pathology was selected, and PSFR values (mm-¹) were calculated. PSFR values were recorded at baseline and at the 26-week follow-up.
Outcome measures
| Measure |
Group A - ESWT + Exercise
n=21 Participants
Participants in group A will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
In addition, participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy will be set to 0.10-0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 shocks are applied from all three sides (medial, lateral, dorsal). The set values will not change throughout the research. These parameters were selected in accordance to ISMST guidelines.
|
Group B - Exercise
n=20 Participants
Participants in group B will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
|
|---|---|---|
|
Peak Spatial Frequency Radius at the Site of Pathology
Week 26
|
2.194 mm^-1
Standard Deviation 0.115
|
2.184 mm^-1
Standard Deviation 0.094
|
|
Peak Spatial Frequency Radius at the Site of Pathology
Baseline
|
2.180 mm^-1
Standard Deviation 0.093
|
2.146 mm^-1
Standard Deviation 0.067
|
PRIMARY outcome
Timeframe: Values at baseline and week 26.The VISA-A questionnaire is a validated, disease-specific patient-reported outcome measure for Achilles tendinopathy. Scores range from 0 to 100 (score on scale), with higher scores indicating better function and fewer symptoms. Scores were recorded at baseline and at the 26-week follow-up.
Outcome measures
| Measure |
Group A - ESWT + Exercise
n=21 Participants
Participants in group A will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
In addition, participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy will be set to 0.10-0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 shocks are applied from all three sides (medial, lateral, dorsal). The set values will not change throughout the research. These parameters were selected in accordance to ISMST guidelines.
|
Group B - Exercise
n=20 Participants
Participants in group B will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
|
|---|---|---|
|
VISA-A Questionnaire Score
Baseline
|
66.9 scores on scale
Standard Deviation 13.2
|
62.9 scores on scale
Standard Deviation 12.8
|
|
VISA-A Questionnaire Score
Week 26
|
92.7 scores on scale
Standard Deviation 7.2
|
86 scores on scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Values at baseline and week 26.Achilles tendon diameter was measured using standardized B-mode ultrasound imaging at the site of maximal tendon width. Measurements were performed using built-in ultrasound system measurement tools. Measurements were recorded at baseline and at the 26-week follow-up.
Outcome measures
| Measure |
Group A - ESWT + Exercise
n=21 Participants
Participants in group A will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
In addition, participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy will be set to 0.10-0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 shocks are applied from all three sides (medial, lateral, dorsal). The set values will not change throughout the research. These parameters were selected in accordance to ISMST guidelines.
|
Group B - Exercise
n=20 Participants
Participants in group B will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
|
|---|---|---|
|
Tendon Diameter at the Place of Maximum Tendon Width
Baseline
|
6.0 mm
Standard Deviation 2.0
|
6.6 mm
Standard Deviation 2.2
|
|
Tendon Diameter at the Place of Maximum Tendon Width
Week 26
|
5.9 mm
Standard Deviation 1.9
|
6.4 mm
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Values at baseline and week 26Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores were recorded at baseline and at the 26-week follow-up.
Outcome measures
| Measure |
Group A - ESWT + Exercise
n=21 Participants
Participants in group A will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
In addition, participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy will be set to 0.10-0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 shocks are applied from all three sides (medial, lateral, dorsal). The set values will not change throughout the research. These parameters were selected in accordance to ISMST guidelines.
|
Group B - Exercise
n=20 Participants
Participants in group B will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
|
|---|---|---|
|
Pain Intensity Measured by Numeric Rating Scale (NRS)
Baseline
|
6.8 scores on a scale
Standard Deviation 1.8
|
5.7 scores on a scale
Standard Deviation 1.6
|
|
Pain Intensity Measured by Numeric Rating Scale (NRS)
Week 26
|
1.8 scores on a scale
Standard Deviation 1.4
|
1.9 scores on a scale
Standard Deviation 1.8
|
Adverse Events
Group A - ESWT + Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B - Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mgr. Jakub Katolický
Second Faculty of Medicine, Charles University
Phone: +420702088258
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place