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The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04138355
Enrollment
48
Registered
2019-10-24
Start date
2019-11-02
Completion date
2020-04-20
Last updated
2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Burn

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.

Interventions

OTHERExtracorporeal shock wave therapy

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.

Sponsors

Hallym University
CollaboratorOTHER
Hangang Sacred Heart Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The patients' burn scars had re-epithelialized after aseptic care or skin graft. We included patients aged ≥18 years with a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands, with joint contracture(hand and wrist), having been transferred to the rehabilitation department after acute burn treatment, and less than 6 months since the onset of the burn injury. Selected patients had a history of hand surgery resulting in painful, retracting scarring on hands.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
melanin and erythema4 weeksmeasure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU)
sebum4 weeksthe severity of greese, the higher values indicating a more greese(mg/cm2)
elasticity4 weeksThe numeric values (mm) of the skin's distortion is presented as the elasticity.
thickness4 weeksscar thickness(cm)
transepithelial water loss4 weeksthe degree of water evaporation

Secondary

MeasureTime frameDescription
Jebsen-Taylor hand function test4 weeksThe 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).
grip strength4 weeksmeasure grip strength, the higher values indicating a more strength

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026