The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hand Burn

Intervention / Treatment
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* Other: Extracorporeal shock wave therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extracorporeal shock wave therapy group<br>. 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. | Other: Extracorporeal shock wave therapy<br>* 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.<br>|
| No Intervention: conventional manual therapy<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness | scar thickness(cm) | 4 weeks | 
| melanin and erythema | measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU) | 4 weeks | 
| transepithelial water loss | the degree of water evaporation | 4 weeks | 
| sebum | the severity of greese, the higher values indicating a more greese(mg/cm2) | 4 weeks | 
| elasticity | The numeric values (mm) of the skin's distortion is presented as the elasticity. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grip strength | measure grip strength, the higher values indicating a more strength | 4 weeks | 
| Jebsen-Taylor hand function test | 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). | 4 weeks |