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NCT Number: NCT06438224

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal shock wave therapy (ESWT)

Other

Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals.

Sham stimulation

Other

the sham group was treated using an adapter that had the same shape but did not emit any energy

Primary outcomes

  1. 10-point visual analog scale (VAS)

    Time frame: 12 weeks

    self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain

Secondary outcomes

  1. the total active motion (TAM) scoring system

    Time frame: 12 weeks

    range of motion measurement, higher scores indicating better range of motion. For each finger, the maximum angle is 260 degrees and the minimum angle is 260 degrees.

  2. Jebsen-Taylor hand function test (JTT)

    Time frame: 12 weeks

    The JTT consists of seven subtests, each scored on a 0-15-point scale, with higher scores indicating better hand function

  3. Grip and pinch strengths

    Time frame: 12 weeks

    quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger

  4. Scar thickness

    Time frame: 12 weeks

    quantified using ultrasonography (128 BW1 US system, Medison, Korea)

  5. erythema

    Time frame: 12 weeks

    Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the melanin levels. Higher values indicated darker.

  6. Trans-epidermal water loss (TEWL)

    Time frame: 12 weeks

    measured using a Tewameter® (Courage-Khazaka Electronic GmbH, Germany) to evaluate water evaporation. Higher values indicated skin dryness

  7. pigmentation

    Time frame: 12 weeks

    Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the severity of erythema. Higher values indicated redder skin.

Study contacts

Contact information is provided by the study sponsor or research team.

Sung Rakyum

CONTACT

[email protected]

82-2-2639-5900

Sponsors and collaborators

Lead sponsor

Hangang Sacred Heart Hospital

Other

Registry information

Official study title

Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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