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Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy

Primary Purpose

Achilles Tendinopathy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
BTL-6000 FSWT
Achilles Tendon Loading Exercise Protocol According to Silbernagel
Sponsored by
University Hospital, Motol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendinopathy focused on measuring Achilles Tendinopathy, Extracorporeal Shockwave Therapy, Ultrasonography

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: the patient shows symptoms of Achilles tendinopathy (pain, swelling and dysfunction in the area of Achilles tendon), which at least partially limit his quality of life during normal or sporting activities, the patient is in the age group of 18-60 years, the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference, the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury), the patient has not undergone any treatment aimed at AS in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective US examination of AS shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.). Exclusion Criteria: patient has been diagnosed with a rheumatic disease or a disease of the central nervous system patient has any condition which is contraindication for ESWT application patient is aware of mechanical damage to the Achilles tendon as a result of an injury in the past.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A - ESWT + exercise

Group B - exercise

Arm Description

Participants in group A will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day. In addition, participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy will be set to 0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 shocks are applied from all three sides (medial, lateral, dorsal). The set values will not change throughout the research. These parameters were selected in accordance to ISMST guidelines.

Participants in group B will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.

Outcomes

Primary Outcome Measures

Change in Peak Spatial Frequency Radius at the site of Pathology
Measured by spatial frequency analysis software from ultrasound picture in mm-1. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.
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.

Secondary Outcome Measures

Change in Tendon Diameter at the Place of Maximum Tendon Width
Measured by measuring tools in ultrasound machine in mm2. In linear view is selected maximal width place, then the tendon diameter is measured using device tools.
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.

Full Information

First Posted
January 18, 2023
Last Updated
April 1, 2023
Sponsor
University Hospital, Motol
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1. Study Identification

Unique Protocol Identification Number
NCT05702918
Brief Title
Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy
Official Title
Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy Using Ultrasonography
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Motol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This work is designed as a randomized clinical trial, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon and low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 40 patients will participate, randomly divided into two groups. Group A will be instructed to perform a training protocol in combination with ESWT according to selected parameters. Group B only completes the same training protocol.
Detailed Description
This work is designed as a randomized clinical trial, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon and low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 40 patients will participate, randomly divided into two groups. Group A will be instructed to perform a training protocol in combination with ESWT according to selected parameters. Group B only completes the same training protocol. The research within one patient will last a total of 39 weeks from the initial to the final examination and will include several control measurements: at 6, 12, 26 and 39 weeks from the beginning of therapy. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software. At the end of the initial examination, the participant will be randomly assigned to group A or B. The study program for a specific participant will depend on the assigned group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy
Keywords
Achilles Tendinopathy, Extracorporeal Shockwave Therapy, Ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be divided into two groups. Group A will follow resistance training protocol and receive ESWT. Group B will follow resistance training only.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A - ESWT + exercise
Arm Type
Active Comparator
Arm Description
Participants in group A will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day. In addition, participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy will be set to 0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 shocks are applied from all three sides (medial, lateral, dorsal). The set values will not change throughout the research. These parameters were selected in accordance to ISMST guidelines.
Arm Title
Group B - exercise
Arm Type
Active Comparator
Arm Description
Participants in group B will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
Intervention Type
Device
Intervention Name(s)
BTL-6000 FSWT
Intervention Description
The energy will be set to 0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 shocks are applied from all three sides (medial, lateral, dorsal).
Intervention Type
Other
Intervention Name(s)
Achilles Tendon Loading Exercise Protocol According to Silbernagel
Intervention Description
It is a 12-week Silbernagel ankle dorsiflexion resistance training protocol. It is a series of exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
Primary Outcome Measure Information:
Title
Change in Peak Spatial Frequency Radius at the site of Pathology
Description
Measured by spatial frequency analysis software from ultrasound picture in mm-1. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.
Time Frame
Change of initial values at 39 weeks follow up after beginning of the therapy.
Title
Change in VISA-A Questionnaire Score
Description
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.
Time Frame
Change of initial values at 39 weeks follow up after beginning of the therapy.
Secondary Outcome Measure Information:
Title
Change in Tendon Diameter at the Place of Maximum Tendon Width
Description
Measured by measuring tools in ultrasound machine in mm2. In linear view is selected maximal width place, then the tendon diameter is measured using device tools.
Time Frame
Change of initial values at 39 weeks follow up after beginning of the therapy.
Title
Change in Maximum Pain in the Achilles Tendon Area
Description
Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.
Time Frame
Change of initial values at 39 weeks follow up after beginning of the therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: the patient shows symptoms of Achilles tendinopathy (pain, swelling and dysfunction in the area of Achilles tendon), which at least partially limit his quality of life during normal or sporting activities, the patient is in the age group of 18-60 years, the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference, the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury), the patient has not undergone any treatment aimed at AS in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective US examination of AS shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.). Exclusion Criteria: patient has been diagnosed with a rheumatic disease or a disease of the central nervous system patient has any condition which is contraindication for ESWT application patient is aware of mechanical damage to the Achilles tendon as a result of an injury in the past.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislav Machač, PhD
Organizational Affiliation
University Hospital Motol and 2nd Faculty of Medicine, Charles University
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Motol and 2nd Faculty of Medicine, Charles University
City
Prague
Country
Czechia

12. IPD Sharing Statement

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Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy

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