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

NCT ID: NCT02257281

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-09-30

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.

Conditions

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Inflammation

Keywords

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Sodium lauryl sulfate Skin irritants inflammation therapeutic ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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 .

Group Type EXPERIMENTAL

Active Therapeutic Ultrasound

Intervention Type DEVICE

For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.

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 .

Group Type PLACEBO_COMPARATOR

Non-active Therapeutic Ultrasound

Intervention Type DEVICE

For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.

Interventions

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Active Therapeutic Ultrasound

For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.

Intervention Type DEVICE

Non-active Therapeutic Ultrasound

For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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GCRC

Chung Shan Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peir Renn Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of rehabilitation

Other Identifiers

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CS14008

Identifier Type: -

Identifier Source: org_study_id