HealthyNCT06210152
Does Radial Extracorporeal Shockwave Therapy Applied to the Achilles Tendon Influence Ankle Functionality?
An observational study of Healthy, run by Hyunjoong Kim at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Radial Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2024to 19 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Radial Extracorporeal Shockwave Therapy, Sham Extracorporeal Shockwave Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal Shockwave TherapyDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Radial Extracorporeal Shockwave Therapy | Not described Receives: Device: Radial Extracorporeal Shockwave Therapy | |
| Sham Extracorporeal Shockwave Therapy | Not described Receives: Device: Sham Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jump height
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.
Measured: Immediate change from baseline after intervention
flying time
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.
Measured: Immediate change from baseline after intervention
contact time
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.
Measured: Immediate change from baseline after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start10 Jan 2024 (estimated)
- Primary completion17 Jan 2024 (estimated)
- Study completion19 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyunjoong Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyunjoong Kim, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210152
- Sponsor's protocol ID
- 2-1040781-A-N-012021092HR
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Radial Extracorporeal Shockwave Therapy on Achilles Tendon on Ankle Functionality
- ClinicalTrials.gov ID
- NCT06210152
- Acronym / sponsor ID
- 2-1040781-A-N-012021092HR
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Hyunjoong KimUniversity, hospital or other
- Study start
- 10 Jan 2024 (estimated)
- Primary completion
- 17 Jan 2024 (estimated)
- Study completion
- 19 Jan 2024 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial Extracorporeal Shockwave Therapy | – | Device: Radial Extracorporeal Shockwave Therapy |
| Sham Extracorporeal Shockwave Therapy | – | Device: Sham Extracorporeal Shockwave Therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial Extracorporeal Shockwave TherapyRadial 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. | Device | Radial Extracorporeal Shockwave Therapy |
| Sham Extracorporeal Shockwave TherapySham 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. | Device | Sham Extracorporeal Shockwave Therapy |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Hyunjoong Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyunjoong Kim, PhD (+82-10-8005-1460, hyun-joongkim@nmslab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jump height (time frame: Immediate change from baseline after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.