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

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

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.

Study Overview

• Status: Completed
• Conditions: Achilles Tendinopathy
• Intervention / Treatment: Device: BTL-6000 FSWT; Device: BTL-6000 FSWT with sham applicator

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • University Hospital Motol and 2nd Faculty of Medicine, Charles University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: BTL-6000 FSWT; Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.
Sham Comparator: 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.	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.

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: University Hospital, Motol
• Investigators: Principal Investigator: Stanislav Machač, Mgr., Ph.D., University Hospital Motol and 2nd Faculty of Medicine, Charles University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): April 2, 2021
• Study Completion (Actual): April 2, 2021

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 28, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasonography; Extracorporeal Shock Wave Therapy; Achilles Tendinopathy
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: EK- 1/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No