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Completed

NCT Number: NCT04138355

The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hand function and hypertrophic scar characteristics. To investigate ESWT effects on burned hands, the investigators compare the results of ESWT combined with manual therapy group to the results of matched conventional(CON) rehabilitation combined with manual therapy group.

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Key information

Conditions

Hand Burn

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangang Sacred Heart Hospital

Seoul, Yeong-deungpo-Dong, 150-719, South Korea

About this study

Hands are the most frequent injury sites caused by burn, and appropriate rehabilitation is essential to ensure that good functional recovery is achieved. In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, red, inflexible and responsible functional and cosmetic impairments.

This randomized, controlled trial involved 40 patients with burns and dominant right-hand function impairment. Patients were randomized into a ESWT or a CON group. Each intervention was applied to the affected hand for 4 weeks once per week. Hand function was evaluated using the Jebsen-Taylor hand function test (JTT), grasp and pinch power test, and Michigan Hand Outcomes Questionnaire (MHQ). These assessments were evaluated pre-intervention and 4 weeks post-intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands
  • less than 6 months since the onset of the burn injury

Exclusion criteria

  • fourth-degree burns(involving muscles, tendons, and bone injuries)\\
  • musculoskeletal diseases(fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) in the burned hands
  • neurological diseases(such as peripheral nerve disorders)
  • preexisting physical and psychologic disability (severe aphasia and cognitive impairment that could influence the intervention)
  • severe pain impeding hand rehabilitation

Treatment and study plan

Extracorporeal Shock Wave Therapy

Other

ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen,Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave. ESWT was performed around the primary treatment site at 100 impulses/cm2, an energy flux density(EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses were administered at 1-week intervals for 4 sessions.

Primary outcomes

  1. thickness

    Time frame: 4 weeks

    scar thickness(cm)

  2. melanin and erythema

    Time frame: 4 weeks

    measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU)

  3. transepithelial water loss

    Time frame: 4 weeks

    the degree of water evaporation

  4. sebum

    Time frame: 4 weeks

    the severity of greese, the higher values indicating a more greese(mg/cm2)

  5. elasticity

    Time frame: 4 weeks

    The numeric values (mm) of the skin's distortion is presented as the elasticity.

Secondary outcomes

  1. grip strength

    Time frame: 4 weeks

    measure grip strength, the higher values indicating a more strength

  2. Jebsen-Taylor hand function test

    Time frame: 4 weeks

    The JTT measure the performance speed of standardized tasks. The JTT involves a series of 7 subtests. We used a scoring system (each subtest score ranged from 0 to 15, and the total score ranged from 0 to 105).

Sponsors and collaborators

Lead sponsor

Hangang Sacred Heart Hospital

Other

Collaborators

  • Hallym University

Registry information

Official study title

The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns : a Randomized Controlled Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 24, 2019
Registry last updated
Apr 24, 2020

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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