Clinical trial NCT04780919: Ultrasound-Monitored Changes in Achilles Tendinopathy After Extracorporeal Shock Wave Therapy
Official title: The Ultrasound-Monitored Changes in Achilles Tendinopathy After Focused Extracorporeal Shock Wave Therapy - a Randomized Sham-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendinopathy
Keywords: Extracorporeal Shock Wave Therapy
Achilles Tendinopathy
Ultrasonography
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are divided into two groups - treatment and placebo.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Cross-sectional Area at the Place of Maximum Tendon Width
timeFrame: Change of initial values at 3 weeks follow up after last application (8th week).
measure: Change in Maximum Pain in the Achilles Tendon Area
timeFrame: Change in maximum pain in the timeframe of the last application (5th week)
measure: Change in Maximum Pain in the Achilles Tendon Area (Follow up)
timeFrame: Change in maximum pain at 3 weeks follow up after last application (8th week).
measure: Change of Ankle Dorsiflexion Range of Motion
timeFrame: Change of initial values at 3 weeks follow up after last application (8th week).
Secondary outcomes:
measure: Number of Participants With Hypoechogenic Areas
timeFrame: Change of the echostructure at 3 weeks follow up after last application (8th week).
measure: Number of Participants With Increased Thickness of Achilles Tendon
timeFrame: Change of the tendon continuity at 3 weeks follow up after last application (8th week).
measure: Change in VISA-A Questionnaire Score
timeFrame: Change of initial values at 3 weeks follow up after last application (8th week).
measure: Change in Single Leg Heel Rise Test
timeFrame: Change of initial values at 3 weeks follow up after last application (8th week)
measure: Change in Single Leg Hop Test
timeFrame: Change of initial values at 3 weeks follow up after last application (8th week).
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: University Hospital Motol and 2nd Faculty of Medicine, Charles University
Study officials:
affiliation: University Hospital Motol and 2nd Faculty of Medicine, Charles University
name: Stanislav Machač, Mgr., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: