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

Last updated: August 18, 2024
Sponsor: Hangang Sacred Heart Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Hyponatremia

Skin Wounds

Treatment

Extracorporeal shock wave therapy (ESWT)

sham stimulation

Clinical Study ID

NCT06438224
HangangSHH-18
  • Ages 18-75
  • All Genders

Study 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

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 asplit-thickness skin graft (STSG) after the thermal injury

  • nerve injury to the hand was confirmed by electromyography

  • < 6 months prior to the enrollment

Exclusion

Exclusion Criteria:

  • musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, anddegenerative joint diseases) of the hands

  • acute infection

  • malignant tumors

  • coagulopathy

  • pregnancy

  • potential for additional skin damage if exposed to ESWT and conventionaloccupational therapy.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Extracorporeal shock wave therapy (ESWT)
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
August 20, 2024

Study Description

Burns that occur in the hand cause early joint range-of-motion (ROM) limitations and hand muscle weakness that significantly affect quality of life. Hand burns, though restricted to a small total body surface area (TBSA), can have significant functional consequences. 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.

The investigators 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.

Connect with a study center

  • Hangang sacred heart hodpital

    Seoul, 07247
    Korea, Republic of

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.