The Effect of Therapeutic Ultrasound on Soft Tissue: An Experimentally-induced Skin Model

Study Overview
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Brief Summary
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The purposes of study are to investigate the effect of therapeutic ultrasound for the inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on different inflammatory level.

Detailed Description
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Therapeutic ultrasound for soft tissue repair has been used in clinical during the past decades. In some recent systematic review, the evidence of clinical trials were insufficiency. We assumed the reaserch biasin clinical trials may be due to the different inflammatory level of soft tissue under the similar ultrasound intensity. Our purpose of study is to investigate the effect of therapeutic ultrasound for the inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on different inflammatory level.

Official Title
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Chung Shan Medical University Hospital Institutional Review Board

Conditions
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Inflammation

Intervention / Treatment
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* Device: Active Therapeutic Ultrasound
* Device: Non-active Therapeutic Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: asia healthy subjects aged 20-45 years Exclusion Criteria: disadvantaged groups systemic disease, such as DM, cancer, autoimmune disorder hyperhidrosis or hypothyroidism a past history of dermatitis active infective or inflammatory cutaneous disease smoking or drinking take medicine, over sun exposure, exercise or menstruation during experimental period contraindication of therapeutic ultrasound

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Therapeutic Ultrasound<br>The three inflammatory forearm spots on the same side induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with active therapeutic ultrasound . | Device: Active Therapeutic Ultrasound<br>* For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.<br>|
| Placebo Comparator: Non-active Therapeutic Ultrasound<br>The contralateral three inflammatory forearm spots induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with non-active therapeutic ultrasound . | Device: Non-active Therapeutic Ultrasound<br>* For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin blood flow |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin temperature |  | 2 weeks | 
| skin water content |  | 2 weeks | 
| Tactile pain threshold |  | 2 weeks | 
| erythema index |  | 2 weeks | 
| skin thickness |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sodium lauryl sulfate, Skin irritants, inflammation, therapeutic ultrasound