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Clinical Trials/NCT04138355
NCT04138355
Completed
Not Applicable

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

Hangang Sacred Heart Hospital1 site in 1 country48 target enrollmentStarted: November 2, 2019Last updated:
ConditionsHand Burn

Overview

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
transepithelial water loss

Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

transepithelial water loss

Time Frame: 4 weeks

the degree of water evaporation

elasticity

Time Frame: 4 weeks

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

thickness

Time Frame: 4 weeks

scar thickness(cm)

sebum

Time Frame: 4 weeks

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

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)

Secondary Outcomes

  • grip strength(4 weeks)
  • Jebsen-Taylor hand function test(4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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