Ultrasound-Monitored Changes in Achilles Tendinopathy After Extracorporeal Shock Wave Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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The Ultrasound-Monitored Changes in Achilles Tendinopathy After Focused Extracorporeal Shock Wave Therapy - a Randomized Sham-Controlled Trial

Conditions
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Achilles Tendinopathy

Intervention / Treatment
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* Device: BTL-6000 FSWT
* Device: BTL-6000 FSWT with sham applicator


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are divided into two groups - treatment and placebo.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group (A)<br>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. | Device: BTL-6000 FSWT<br>* Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.<br>|
| Sham Comparator: Sham Group (B)<br>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. | Device: BTL-6000 FSWT with sham applicator<br>* Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Shock Wave Therapy, Achilles Tendinopathy, Ultrasonography