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

NCT ID: NCT04780919

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-04-02

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.

Conditions

Achilles Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

BTL-6000 FSWT

Intervention Type: DEVICE

Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.

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.

Group Type: SHAM_COMPARATOR

BTL-6000 FSWT with sham applicator

Intervention Type: DEVICE

Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission.

Interventions

BTL-6000 FSWT

Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Motol

OTHER

Sponsor Role: lead

Responsible Party

Stanislav Machač, Ph.D

Academic worker

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanislav Machač, Mgr., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Motol and 2nd Faculty of Medicine, Charles University

Locations

University Hospital Motol and 2nd Faculty of Medicine, Charles University

Prague, , Czechia

Countries

Czechia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EK- 1/21

Identifier Type: -

Identifier Source: org_study_id