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

Chung Shan Medical University

Status: Completed

Conditions: Inflammation

Treatments: Device: Non-active Therapeutic Ultrasound; Device: Active Therapeutic Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02257281

CS14008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups, including a placebo group

Active Therapeutic Ultrasound

Experimental group

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 .

Treatment:

Device: Active Therapeutic Ultrasound

Non-active Therapeutic Ultrasound

Placebo Comparator group

Description:

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

Treatment:

Device: Non-active Therapeutic Ultrasound