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Recruiting NCT06438224

NCT06438224 Clinical Utility of ESWT in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns

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Clinical Trial Summary
NCT ID NCT06438224
Status Recruiting
Phase
Sponsor Hangang Sacred Heart Hospital
Condition Hand Injuries
Study Type INTERVENTIONAL
Enrollment 120 participants
Start Date 2023-01-01
Primary Completion 2024-07-10

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 75 Years
Study Type INTERVENTIONAL
Interventions
Extracorporeal shock wave therapy (ESWT)sham stimulation

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 120 participants in total. It began in 2023-01-01 with a primary completion date of 2024-07-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns. Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. The investigators planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment.

Eligibility Criteria

Inclusion Criteria: * ≥ 18 years old * had sustained a deep partial-thickness (second-degree) or a full-thickness (third-degree) burn in the right dominant hand, which had been treated with a split-thickness skin graft (STSG) after the thermal injury * nerve injury to the hand was confirmed by electromyography * \< 6 months prior to the enrollment Exclusion Criteria: * musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) of the hands * acute infection * malignant tumors * coagulopathy * pregnancy * potential for additional skin damage if exposed to ESWT and conventional occupational therapy.

Contact & Investigator

Central Contact

Sung Rakyum

✉ sung6652@hallym.or.kr

📞 82-2-2639-5900

Principal Investigator

SO YOUNG JOO

PRINCIPAL INVESTIGATOR

handgang sacred heart hospital

Frequently Asked Questions

Who can join the NCT06438224 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hand Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06438224 currently recruiting?

Yes, NCT06438224 is actively recruiting participants. Contact the research team at sung6652@hallym.or.kr for enrollment information.

Where is the NCT06438224 trial being conducted?

This trial is being conducted at Seoul, South Korea.

Who is sponsoring the NCT06438224 clinical trial?

NCT06438224 is sponsored by Hangang Sacred Heart Hospital. The principal investigator is SO YOUNG JOO at handgang sacred heart hospital. The trial plans to enroll 120 participants.

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