Does Radial Extracorporeal Shockwave Therapy Applied to the Achilles Tendon Influence Ankle Functionality?

January 6, 2024 updated by: Hyunjoong Kim

Influence of Radial Extracorporeal Shockwave Therapy on Achilles Tendon on Ankle Functionality

Radial Extracorporeal Shockwave Therapy has been shown to restore shortened muscles and normalize fibrotic tissues in muscles or fascia. Shockwave therapy can soften fibrotic tissues and alleviate pain. While there are various methods to relax muscles and fascia, radial extracorporeal shockwave therapy can achieve good results in a short treatment time. Although there is research on the pain-related effects of radial extracorporeal shockwave therapy for conditions such as plantar fasciitis and knee osteoarthritis, there is a lack of literature on its functional effects. Therefore, this study aims to investigate the improvement of ankle functionality through the application of radial extracorporeal shockwave therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The recruitment of participants for the study is planned to take place in Han-nam-dong and at Sahmyook University in Seoul, Republic of Korea. Potential participants selected through recruitment documents will be enrolled upon meeting the eligibility criteria. After providing a comprehensive explanation of the study, those who voluntarily agree to participate will be recruited.

Description

Inclusion Criteria:

  • Individuals who have ankle-related pain scores of 0 to 2 on the Numeric Pain Rating Scale (NPRS).
  • Individuals with no functional impairment in the ankle.

Exclusion Criteria:

  • Individuals who have undergone surgical procedures such as ankle joint arthrodesis.
  • Individuals showing signs of functional impairment in ankle functionality.
  • Individuals with ankle-related pain rated above 3 on the NPRS.
  • Individuals with acute ankle fractures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Radial Extracorporeal Shockwave Therapy
Device: Radial Extracorporeal Shockwave Therapy
Radial Extracorporeal Shockwave Therapy (rESWT) was administered using the Masterpuls® MP200 device (Storz Medical AG, Tägerwilen, Switzerland). Participants were seated with their calves exposed. A coupling gel was applied to the Achilles tendon area and, adhering to the 90° application rule, a 15-mm applicator was used in both transverse and diagonal patterns at the myotendinous junction, extending across the muscle belly using a smoothing motion. Each session involved the delivery of 1000 pulses at a frequency of 10Hz and an air pressure setting of 1.0 bar.
Sham Extracorporeal Shockwave Therapy
Device: Sham Extracorporeal Shockwave Therapy
Sham Extracorporeal Shockwave Therapy (rESWT) was administered using the Masterpuls® MP200 device (Storz Medical AG, Tägerwilen, Switzerland). Participants were seated with their calves exposed. A coupling gel was applied to the Achilles tendon area and, adhering to the 90° application rule, a 15-mm applicator was used in both transverse and diagonal patterns at the myotendinous junction, extending across the muscle belly using a smoothing motion. In each session, the device was held against the achilles tendon without being powered on.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Jump height
Time Frame: Immediate change from baseline after intervention
The Single-Leg Vertical Jump is measured using the OptoGait System (Microgate, S.R.L, Bolzano, Italy, 2010) to determine maximum height, flight time, and ground contact time. Higher jumps, longer flight times, and shorter ground contact times indicate improved single-leg vertical jump performance. The setup involves placing two parallel bars embedded with sensors on either side and positioning a camera in front. Participants, with their shoes removed, enter between the bars. They are instructed to "Please jump as high as you can, five times," with the command given loudly. After five jumps, the collected data are processed using the OptoGait software (Version 1.5.0.0, Microgate, S.R.L). Jump height (cm) is calculated from the maximum jump height in OptoGait.
Immediate change from baseline after intervention
flying time
Time Frame: Immediate change from baseline after intervention
The Single-Leg Vertical Jump is measured using the OptoGait System (Microgate, S.R.L, Bolzano, Italy, 2010) to determine maximum height, flight time, and ground contact time. Higher jumps, longer flight times, and shorter ground contact times indicate improved single-leg vertical jump performance. The setup involves placing two parallel bars embedded with sensors on either side and positioning a camera in front. Participants, with their shoes removed, enter between the bars. They are instructed to "Please jump as high as you can, five times," with the command given loudly. After five jumps, the collected data are processed using the OptoGait software (Version 1.5.0.0, Microgate, S.R.L). Flying time (msec) is calculated as hover time when jumping in OptoGait.
Immediate change from baseline after intervention
contact time
Time Frame: Immediate change from baseline after intervention
The Single-Leg Vertical Jump is measured using the OptoGait System (Microgate, S.R.L, Bolzano, Italy, 2010) to determine maximum height, flight time, and ground contact time. Higher jumps, longer flight times, and shorter ground contact times indicate improved single-leg vertical jump performance. The setup involves placing two parallel bars embedded with sensors on either side and positioning a camera in front. Participants, with their shoes removed, enter between the bars. They are instructed to "Please jump as high as you can, five times," with the command given loudly. After five jumps, the collected data are processed using the OptoGait software (Version 1.5.0.0, Microgate, S.R.L). Contact time (msec) is calculated by OptoGait as the time on the floor before jumping.
Immediate change from baseline after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hyunjoong Kim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2-1040781-A-N-012021092HR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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