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

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: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: Radial Extracorporeal Shockwave Therapy; Device: Sham Extracorporeal Shockwave Therapy

• Study Type: Observational
• Enrollment (Estimated): 33

Contacts and Locations

• Study Contact: Name: Hyunjoong Kim, PhD; Phone Number: +82-10-8005-1460; Email: hyun-joongkim@nmslab.org

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 01795
    • Sahmyook University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hyunjoong Kim

Study record dates

Study Major Dates

• Study Start (Estimated): January 10, 2024
• Primary Completion (Estimated): January 17, 2024
• Study Completion (Estimated): January 19, 2024

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 6, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID 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