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

Not Applicable

Completed

• Conditions: Inflammation
• Interventions: Device: Non-active Therapeutic Ultrasound; Device: Active Therapeutic Ultrasound

• Registration Number: NCT02257281
• Lead Sponsor: Chung Shan Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-06
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-13
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. asia healthy subjects
2. aged 20-45 years

Exclusion Criteria

1. disadvantaged groups
2. systemic disease, such as DM, cancer, autoimmune disorder
3. hyperhidrosis or hypothyroidism
4. a past history of dermatitis
5. active infective or inflammatory cutaneous disease
6. smoking or drinking
7. take medicine, over sun exposure, exercise or menstruation during experimental period
8. contraindication of therapeutic ultrasound

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-active Therapeutic Ultrasound	Non-active Therapeutic Ultrasound	The contralateral three inflammatory forearm spots induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with non-active therapeutic ultrasound .
Active Therapeutic Ultrasound	Active Therapeutic Ultrasound	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 .

Primary Outcome Measures

Name	Time	Method
skin blood flow	2 weeks

Secondary Outcome Measures

Name	Time	Method
skin temperature	2 weeks
skin water content	2 weeks
skin thickness	2 weeks
erythema index	2 weeks
Tactile pain threshold	2 weeks