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

Inflammation Clinical Trial

Official title:

Chung Shan Medical University Hospital Institutional Review Board

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257281
• Other study ID #: CS14008
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: December 13, 2015
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation

Intervention

Device:
• Active Therapeutic Ultrasound
For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.
• Non-active Therapeutic Ultrasound
For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin blood flow		2 weeks	Yes
Secondary	skin temperature		2 weeks	Yes
Secondary	skin water content		2 weeks	Yes
Secondary	Tactile pain threshold		2 weeks	Yes
Secondary	erythema index		2 weeks	Yes
Secondary	skin thickness		2 weeks	Yes