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

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ClinicalTrials.gov Identifier: NCT04780919
Recruitment Status : Completed
First Posted : March 4, 2021
Results First Posted : June 2, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Stanislav Machač, Ph.D, Charles University, Czech Republic

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.


Condition or disease Intervention/treatment Phase
Achilles Tendinopathy Device: BTL-6000 FSWT Device: BTL-6000 FSWT with sham applicator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are divided into two groups - treatment and placebo.
Masking: Single (Participant)
Masking Description: Participants don't know which group (either treatment or placebo) they are in.
Primary Purpose: Treatment
Official Title: The Ultrasound-Monitored Changes in Achilles Tendinopathy After Focused Extracorporeal Shock Wave Therapy - a Randomized Sham-Controlled Trial
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : April 2, 2021
Actual Study Completion Date : April 2, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780919


Locations
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Czechia
University Hospital Motol and 2nd Faculty of Medicine, Charles University
Prague, Czechia
Sponsors and Collaborators
University Hospital, Motol
Investigators
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Principal Investigator: Stanislav Machač, Mgr., Ph.D. University Hospital Motol and 2nd Faculty of Medicine, Charles University
  Study Documents (Full-Text)

Documents provided by Stanislav Machač, Ph.D, Charles University, Czech Republic:
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Responsible Party: Stanislav Machač, Ph.D, Academic worker, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT04780919    
Other Study ID Numbers: EK- 1/21
First Posted: March 4, 2021    Key Record Dates
Results First Posted: June 2, 2021
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stanislav Machač, Ph.D, Charles University, Czech Republic:
Extracorporeal Shock Wave Therapy
Achilles Tendinopathy
Ultrasonography
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries