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

NCT06210152 | Unknown

• 1 other identifier: 2-1040781-A-N-012021092HR
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Immediate change from baseline after intervention

Study Arms (2)

Radial Extracorporeal Shockwave Therapy

Device: Radial Extracorporeal Shockwave Therapy

Sham Extracorporeal Shockwave Therapy

Device: Sham Extracorporeal Shockwave Therapy

Interventions

Radial Extracorporeal Shockwave Therapy DEVICE

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.

Radial Extracorporeal Shockwave Therapy

Sham Extracorporeal Shockwave Therapy DEVICE

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.

Sham Extracorporeal Shockwave Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hyunjoong Kim: lead

Study Sites (1)

Sahmyook University

Seoul, 01795, South Korea

Location

Central Study Contacts

Hyunjoong Kim, PhD

CONTACT

+82-10-8005-1460; hyun-joongkim@nmslab.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 18, 2024
• Study Start: January 10, 2024
• Primary Completion: January 17, 2024
• Study Completion: January 19, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)