Trial Outcomes & Findings for Ultrasound-Monitored Changes in Achilles Tendinopathy After Extracorporeal Shock Wave Therapy (NCT NCT04780919)
NCT ID: NCT04780919
Last Updated: 2021-06-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Change of initial values at 3 weeks follow up after last application (8th week).
Results posted on
2021-06-28
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Group (A)
n=9 Participants
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.
|
Sham Group (B)
n=9 Participants
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.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
18 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 9.6 • n=9 Participants
|
43.2 years
STANDARD_DEVIATION 12.3 • n=9 Participants
|
39.3 years
STANDARD_DEVIATION 11.5 • n=18 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
26.5 kg/m^2
STANDARD_DEVIATION 4.4 • n=9 Participants
|
32.7 kg/m^2
STANDARD_DEVIATION 7.5 • n=9 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 6.8 • n=18 Participants
|
|
Duration of difficulties
|
6 months
STANDARD_DEVIATION 3.8 • n=9 Participants
|
7.6 months
STANDARD_DEVIATION 4.4 • n=9 Participants
|
6.8 months
STANDARD_DEVIATION 4.1 • n=18 Participants
|
|
Baseline maximal pain
|
6.6 units on a scale
STANDARD_DEVIATION 1.7 • n=9 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 2.3 • n=9 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 2 • n=18 Participants
|
|
Baseline VISA-A score
|
64.3 score on a scale
STANDARD_DEVIATION 12.1 • n=9 Participants
|
65.3 score on a scale
STANDARD_DEVIATION 15.9 • n=9 Participants
|
64.8 score on a scale
STANDARD_DEVIATION 13.7 • n=18 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment Group (A)
n=9 Participants
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.
|
Sham Group (B)
n=9 Participants
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.
|
|---|---|---|
|
Change in Cross-sectional Area at the Place of Maximum Tendon Width
Baseline
|
0.8 cm^2
Standard Deviation 0.19
|
0.76 cm^2
Standard Deviation 0.18
|
|
Change in Cross-sectional Area at the Place of Maximum Tendon Width
3 weeks follow up after last application
|
0.78 cm^2
Standard Deviation 0.2
|
0.69 cm^2
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment Group (A)
n=9 Participants
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.
|
Sham Group (B)
n=9 Participants
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.
|
|---|---|---|
|
Change in Maximum Pain in the Achilles Tendon Area
Baseline
|
6.6 units on a scale
Standard Deviation 1.7
|
6.1 units on a scale
Standard Deviation 2.3
|
|
Change in Maximum Pain in the Achilles Tendon Area
Timeframe of last application
|
3.6 units on a scale
Standard Deviation 1.4
|
5.2 units on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment Group (A)
n=9 Participants
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.
|
Sham Group (B)
n=9 Participants
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.
|
|---|---|---|
|
Change in Maximum Pain in the Achilles Tendon Area (Follow up)
Baseline
|
6.6 units on a scale
Standard Deviation 1.7
|
6.1 units on a scale
Standard Deviation 2.3
|
|
Change in Maximum Pain in the Achilles Tendon Area (Follow up)
3 weeks follow up after last application
|
2.7 units on a scale
Standard Deviation 1.8
|
5 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Change of initial values at 3 weeks follow up after last application (8th week).Measured using weight-bearing lunge test in cm.
Outcome measures
| Measure |
Treatment Group (A)
n=9 Participants
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.
|
Sham Group (B)
n=9 Participants
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.
|
|---|---|---|
|
Change of Ankle Dorsiflexion Range of Motion
Baseline
|
7.4 cm
Standard Deviation 3
|
8.7 cm
Standard Deviation 2.9
|
|
Change of Ankle Dorsiflexion Range of Motion
3 weeks follow up after last application
|
10.1 cm
Standard Deviation 2.5
|
8.7 cm
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Change of the echostructure at 3 weeks follow up after last application (8th week).Echostructure is evaluated visually by investigator using musculoskeletal ultrasound machine. Patients who have a hypoechogenic areas in the tendon are counted.
Outcome measures
| Measure |
Treatment Group (A)
n=9 Participants
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.
|
Sham Group (B)
n=9 Participants
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.
|
|---|---|---|
|
Number of Participants With Hypoechogenic Areas
Baseline
|
6 Participants
|
6 Participants
|
|
Number of Participants With Hypoechogenic Areas
3 weeks follow up after last application
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Change of the tendon continuity at 3 weeks follow up after last application (8th week).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.
Outcome measures
| Measure |
Treatment Group (A)
n=9 Participants
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.
|
Sham Group (B)
n=9 Participants
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.
|
|---|---|---|
|
Number of Participants With Increased Thickness of Achilles Tendon
Baseline
|
5 Participants
|
4 Participants
|
|
Number of Participants With Increased Thickness of Achilles Tendon
3 weeks follow up after last application
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Change of initial values at 3 weeks follow up after last application (8th week).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.
Outcome measures
| Measure |
Treatment Group (A)
n=9 Participants
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.
|
Sham Group (B)
n=9 Participants
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.
|
|---|---|---|
|
Change in VISA-A Questionnaire Score
Baseline
|
64.3 score on a scale
Standard Deviation 12.1
|
65.3 score on a scale
Standard Deviation 15.9
|
|
Change in VISA-A Questionnaire Score
3 weeks follow up after last application
|
84.9 score on a scale
Standard Deviation 9.9
|
69.2 score on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: Change of initial values at 3 weeks follow up after last application (8th week)Population: 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).
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.
Outcome measures
| Measure |
Treatment Group (A)
n=9 Participants
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.
|
Sham Group (B)
n=8 Participants
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.
|
|---|---|---|
|
Change in Single Leg Heel Rise Test
Baseline
|
16.6 repetitions
Standard Deviation 5.8
|
21.8 repetitions
Standard Deviation 10.8
|
|
Change in Single Leg Heel Rise Test
3 weeks follow up after last application
|
26.4 repetitions
Standard Deviation 7.6
|
26.5 repetitions
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: Change of initial values at 3 weeks follow up after last application (8th week).Population: 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).
Patient performs as many hops on one leg as possible in 30 seconds or until first sign of pain in Achilles tendon area.
Outcome measures
| Measure |
Treatment Group (A)
n=9 Participants
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.
|
Sham Group (B)
n=8 Participants
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.
|
|---|---|---|
|
Change in Single Leg Hop Test
3 weeks follow up after last application
|
51.9 repetitions
Standard Deviation 12.7
|
45.0 repetitions
Standard Deviation 23.5
|
|
Change in Single Leg Hop Test
Baseline
|
31.1 repetitions
Standard Deviation 16.9
|
29.5 repetitions
Standard Deviation 23.6
|
Adverse Events
Treatment Group (A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Group (B)
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
Jakub Katolicky
Charles University, 2nd Faculty of Medicine
Phone: +420 739 081 676
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place