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Completed

NCT Number: NCT04780919

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

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.

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Key information

Conditions

Achilles Tendinopathy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Prague, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BTL-6000 FSWT

Device

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

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.

Primary outcomes

  1. Change in Cross-sectional Area at the Place of Maximum Tendon Width

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

    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.

  2. Change in Maximum Pain in the Achilles Tendon Area

    Time frame: Change in maximum pain in the timeframe of the last application (5th week)

    Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.

  3. Change in Maximum Pain in the Achilles Tendon Area (Follow up)

    Time frame: Change in maximum pain at 3 weeks follow up after last application (8th week).

    Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.

  4. Change of Ankle Dorsiflexion Range of Motion

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

    Measured using weight-bearing lunge test in cm.

Secondary outcomes

  1. Number of Participants With Hypoechogenic Areas

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

    Echostructure is evaluated visually by investigator using musculoskeletal ultrasound machine. Patients who have a hypoechogenic areas in the tendon are counted.

  2. Number of Participants With Increased Thickness of Achilles Tendon

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

    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.

  3. Change in VISA-A Questionnaire Score

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

    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.

  4. Change in Single Leg Heel Rise Test

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

    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.

  5. Change in Single Leg Hop Test

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

    Patient performs as many hops on one leg as possible in 30 seconds or until first sign of pain in Achilles tendon area.

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2021
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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