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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.
Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission.
University Hospital Motol and 2nd Faculty of Medicine, Charles University
Prague, Czechia
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).
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)
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).
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).
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).
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).
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).
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)
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).
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