Achilles Tendinopathy
Conditions
Keywords
Extracorporeal Shock Wave Therapy, Achilles Tendinopathy, Ultrasonography
Brief 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. 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.
Interventions
DEVICEBTL-6000 FSWT
Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.
DEVICEBTL-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.
Sponsors
University Hospital, Motol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants don't know which group (either treatment or placebo) they are in.
Intervention model description
Participants are divided into two groups - treatment and placebo.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cross-sectional Area at the Place of Maximum Tendon Width | 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 | 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) | 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 | Change of initial values at 3 weeks follow up after last application (8th week). | Measured using weight-bearing lunge test in cm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hypoechogenic Areas | 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. |
| Change in Single Leg Hop Test | Change of initial values at 3 weeks follow up after last application (8th week). | Patient performs as many hops on one leg as possible in 30 seconds or until first sign of pain in Achilles tendon area. |
| Number of Participants With Increased Thickness of Achilles Tendon | 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. |
| Change in VISA-A Questionnaire Score | 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. |
| Change in Single Leg Heel Rise Test | Change of initial values at 3 weeks follow up after last application (8th week) | 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. |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Treatment Group (A) | Sham Group (B) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Continuous | 35.3 years STANDARD_DEVIATION 9.6 | 43.2 years STANDARD_DEVIATION 12.3 | 39.3 years STANDARD_DEVIATION 11.5 |
| Baseline maximal pain | 6.6 units on a scale STANDARD_DEVIATION 1.7 | 6.1 units on a scale STANDARD_DEVIATION 2.3 | 6.3 units on a scale STANDARD_DEVIATION 2 |
| Baseline VISA-A score | 64.3 score on a scale STANDARD_DEVIATION 12.1 | 65.3 score on a scale STANDARD_DEVIATION 15.9 | 64.8 score on a scale STANDARD_DEVIATION 13.7 |
| Body Mass Index | 26.5 kg/m^2 STANDARD_DEVIATION 4.4 | 32.7 kg/m^2 STANDARD_DEVIATION 7.5 | 29.6 kg/m^2 STANDARD_DEVIATION 6.8 |
| Duration of difficulties | 6 months STANDARD_DEVIATION 3.8 | 7.6 months STANDARD_DEVIATION 4.4 | 6.8 months STANDARD_DEVIATION 4.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
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.
Time frame: Change of initial values at 3 weeks follow up after last application (8th week).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group (A) | Change in Cross-sectional Area at the Place of Maximum Tendon Width | Baseline | 0.8 cm^2 | Standard Deviation 0.19 |
| Treatment Group (A) | 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 |
| Sham Group (B) | Change in Cross-sectional Area at the Place of Maximum Tendon Width | Baseline | 0.76 cm^2 | Standard Deviation 0.18 |
| Sham Group (B) | Change in Cross-sectional Area at the Place of Maximum Tendon Width | 3 weeks follow up after last application | 0.69 cm^2 | Standard Deviation 0.14 |
Comparison: The Group A will have significantly decreased Cross Section Area compared to Group B at 3 weeks follow up after last application.p-value: 0.722Two-way ANOVA
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.
Time frame: Change in maximum pain in the timeframe of the last application (5th week)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group (A) | Change in Maximum Pain in the Achilles Tendon Area | Baseline | 6.6 units on a scale | Standard Deviation 1.7 |
| Treatment Group (A) | Change in Maximum Pain in the Achilles Tendon Area | Timeframe of last application | 3.6 units on a scale | Standard Deviation 1.4 |
| Sham Group (B) | Change in Maximum Pain in the Achilles Tendon Area | Baseline | 6.1 units on a scale | Standard Deviation 2.3 |
| Sham Group (B) | Change in Maximum Pain in the Achilles Tendon Area | Timeframe of last application | 5.2 units on a scale | Standard Deviation 1.9 |
Comparison: The maximum pain will decrease significantly more in Group A compared to Group B in the timeframe of the last application compared to baseline.p-value: 0.096Two-way ANOVA
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.
Time frame: Change in maximum pain at 3 weeks follow up after last application (8th week).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group (A) | Change in Maximum Pain in the Achilles Tendon Area (Follow up) | Baseline | 6.6 units on a scale | Standard Deviation 1.7 |
| Treatment Group (A) | 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 |
| Sham Group (B) | Change in Maximum Pain in the Achilles Tendon Area (Follow up) | Baseline | 6.1 units on a scale | Standard Deviation 2.3 |
| Sham Group (B) | Change in Maximum Pain in the Achilles Tendon Area (Follow up) | 3 weeks follow up after last application | 5 units on a scale | Standard Deviation 2.1 |
Comparison: The maximum pain will decrease significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.p-value: 0.035Two-way ANOVA
Primary
Change of Ankle Dorsiflexion Range of Motion
Measured using weight-bearing lunge test in cm.
Time frame: Change of initial values at 3 weeks follow up after last application (8th week).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group (A) | Change of Ankle Dorsiflexion Range of Motion | Baseline | 7.4 cm | Standard Deviation 3 |
| Treatment Group (A) | Change of Ankle Dorsiflexion Range of Motion | 3 weeks follow up after last application | 10.1 cm | Standard Deviation 2.5 |
| Sham Group (B) | Change of Ankle Dorsiflexion Range of Motion | Baseline | 8.7 cm | Standard Deviation 2.9 |
| Sham Group (B) | Change of Ankle Dorsiflexion Range of Motion | 3 weeks follow up after last application | 8.7 cm | Standard Deviation 3 |
Comparison: The maximum of ankle dorsiflexion range of motion will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.p-value: 0.171Two-way ANOVA
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group (A) | Change in Single Leg Heel Rise Test | Baseline | 16.6 repetitions | Standard Deviation 5.8 |
| Treatment Group (A) | Change in Single Leg Heel Rise Test | 3 weeks follow up after last application | 26.4 repetitions | Standard Deviation 7.6 |
| Sham Group (B) | Change in Single Leg Heel Rise Test | Baseline | 21.8 repetitions | Standard Deviation 10.8 |
| Sham Group (B) | Change in Single Leg Heel Rise Test | 3 weeks follow up after last application | 26.5 repetitions | Standard Deviation 17.4 |
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group (A) | Change in Single Leg Hop Test | Baseline | 31.1 repetitions | Standard Deviation 16.9 |
| Treatment Group (A) | Change in Single Leg Hop Test | 3 weeks follow up after last application | 51.9 repetitions | Standard Deviation 12.7 |
| Sham Group (B) | Change in Single Leg Hop Test | Baseline | 29.5 repetitions | Standard Deviation 23.6 |
| Sham Group (B) | Change in Single Leg Hop Test | 3 weeks follow up after last application | 45.0 repetitions | Standard Deviation 23.5 |
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.
Time frame: Change of initial values at 3 weeks follow up after last application (8th week).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group (A) | Change in VISA-A Questionnaire Score | Baseline | 64.3 score on a scale | Standard Deviation 12.1 |
| Treatment Group (A) | Change in VISA-A Questionnaire Score | 3 weeks follow up after last application | 84.9 score on a scale | Standard Deviation 9.9 |
| Sham Group (B) | Change in VISA-A Questionnaire Score | Baseline | 65.3 score on a scale | Standard Deviation 15.9 |
| Sham Group (B) | Change in VISA-A Questionnaire Score | 3 weeks follow up after last application | 69.2 score on a scale | Standard Deviation 20 |
Comparison: The VISA-A score will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.p-value: 0.104Two-way ANOVA
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.
Time frame: Change of the echostructure at 3 weeks follow up after last application (8th week).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group (A) | Number of Participants With Hypoechogenic Areas | Baseline | 6 Participants |
| Treatment Group (A) | Number of Participants With Hypoechogenic Areas | 3 weeks follow up after last application | 6 Participants |
| Sham Group (B) | Number of Participants With Hypoechogenic Areas | Baseline | 6 Participants |
| Sham Group (B) | Number of Participants With Hypoechogenic Areas | 3 weeks follow up after last application | 6 Participants |
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.
Time frame: Change of the tendon continuity at 3 weeks follow up after last application (8th week).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group (A) | Number of Participants With Increased Thickness of Achilles Tendon | Baseline | 5 Participants |
| Treatment Group (A) | Number of Participants With Increased Thickness of Achilles Tendon | 3 weeks follow up after last application | 5 Participants |
| Sham Group (B) | Number of Participants With Increased Thickness of Achilles Tendon | Baseline | 4 Participants |
| Sham Group (B) | Number of Participants With Increased Thickness of Achilles Tendon | 3 weeks follow up after last application | 4 Participants |