Back to resultsThe Effect of Therapeutic Ultrasound on Soft Tissue: An Experimentally-induced Skin Model
Primary Purpose
Inflammation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active Therapeutic Ultrasound
Non-active Therapeutic Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring Sodium lauryl sulfate, Skin irritants, inflammation, therapeutic ultrasound
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Therapeutic Ultrasound
Non-active Therapeutic Ultrasound
Arm Description
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 .
The contralateral three inflammatory forearm spots induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with non-active therapeutic ultrasound .
Outcomes
Primary Outcome Measures
skin blood flow
Secondary Outcome Measures
skin temperature
skin water content
Tactile pain threshold
erythema index
skin thickness
Full Information
NCT ID
NCT02257281
First Posted
October 2, 2014
Last Updated
December 13, 2015
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02257281
Brief Title
The Effect of Therapeutic Ultrasound on Soft Tissue: An Experimentally-induced Skin Model
Official Title
Chung Shan Medical University Hospital Institutional Review Board
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Sodium lauryl sulfate, Skin irritants, inflammation, therapeutic ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Therapeutic Ultrasound
Arm Type
Experimental
Arm Description
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 .
Arm Title
Non-active Therapeutic Ultrasound
Arm Type
Placebo Comparator
Arm Description
The contralateral three inflammatory forearm spots induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with non-active therapeutic ultrasound .
Intervention Type
Device
Intervention Name(s)
Active Therapeutic Ultrasound
Intervention Description
For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.
Intervention Type
Device
Intervention Name(s)
Non-active Therapeutic Ultrasound
Intervention Description
For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.
Primary Outcome Measure Information:
Title
skin blood flow
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
skin temperature
Time Frame
2 weeks
Title
skin water content
Time Frame
2 weeks
Title
Tactile pain threshold
Time Frame
2 weeks
Title
erythema index
Time Frame
2 weeks
Title
skin thickness
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peir Renn Wang, MD
Organizational Affiliation
Department of rehabilitation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Effect of Therapeutic Ultrasound on Soft Tissue: An Experimentally-induced Skin Model
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