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The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

H

Hangang Sacred Heart Hospital

Status

Completed

Conditions

Hand Burn

Treatments

Other: Extracorporeal shock wave therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04138355
HangangSHH-7

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

Extracorporeal shock wave therapy group
Experimental group
Description:
. 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.
Treatment:
Other: Extracorporeal shock wave therapy
conventional manual therapy
No Intervention group
Description:
the same shock wave equipment used in the experimental group was used with a sham adapter that had the same shape but emitted no energy.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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