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

Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780919
• Other study ID #: EK- 1/21
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: April 2, 2021

Study information

• Verified date: June 2021
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Device:
• BTL-6000 FSWT
Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Motol and 2nd Faculty of Medicine, Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Change of initial values at 3 weeks follow up after last application (8th week).
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.	Change in maximum pain in the timeframe of the last application (5th week)
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.	Change in maximum pain at 3 weeks follow up after last application (8th week).
Primary	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	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).
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.	Change of the tendon continuity at 3 weeks follow up after last application (8th week).
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.	Change of initial values at 3 weeks follow up after last application (8th week).
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.	Change of initial values at 3 weeks follow up after last application (8th week)
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.	Change of initial values at 3 weeks follow up after last application (8th week).