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

NCT04780919 | Completed Results

• 1 other identifier: EK- 1/21
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendinopathy

Keywords

Extracorporeal Shock Wave Therapy; Achilles Tendinopathy; Ultrasonography

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Number of Participants With Hypoechogenic Areas

  Change of the echostructure at 3 weeks follow up after last application (8th week).

• Number of Participants With Increased Thickness of Achilles Tendon

  Change of the tendon continuity at 3 weeks follow up after last application (8th week).

• Change in VISA-A Questionnaire Score

  Change of initial values at 3 weeks follow up after last application (8th week).

• Change in Single Leg Heel Rise Test

  Change of initial values at 3 weeks follow up after last application (8th week)

• Change in Single Leg Hop Test

  Change of initial values at 3 weeks follow up after last application (8th week).

Study Arms (2)

Treatment Group (A)

EXPERIMENTAL

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

Sham Group (B)

SHAM COMPARATOR

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

Interventions

BTL-6000 FSWT DEVICE

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

Treatment Group (A)

BTL-6000 FSWT with sham applicator DEVICE

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

Sham Group (B)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

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

Prague, Czechia

Location

Results Point of Contact

• Title: Jakub Katolicky
• Organization: Charles University, 2nd Faculty of Medicine

jakub@katolicky.eu

+420 739 081 676

Study Officials

• Stanislav Machač, Mgr., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants don't know which group (either treatment or placebo) they are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic worker

Model Details: Participants are divided into two groups - treatment and placebo.

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 4, 2021
• Study Start: February 1, 2021
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: June 28, 2021
• Results First Posted: June 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)