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

December 13, 2015 updated by: GCRC, Chung Shan Medical University

Chung Shan Medical University Hospital Institutional Review Board

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 .
Device: Active Therapeutic Ultrasound
For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.
Placebo Comparator: 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 .
Device: Non-active Therapeutic Ultrasound
For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
skin blood flow
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Principal Investigator: Peir Renn Wang, MD, Department of Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (Estimate)

October 6, 2014

Study Record Updates

Last Update Posted (Estimate)

December 15, 2015

Last Update Submitted That Met QC Criteria

December 13, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS14008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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