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

Chung Shan Medical University Hospital Institutional Review Board

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02257281

Enrollment

Registered

2014-10-06

Start date

2014-10-31

Completion date

2015-09-30

Last updated

2015-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

Sodium lauryl sulfate, Skin irritants, inflammation, therapeutic ultrasound

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.

Interventions

DEVICEActive Therapeutic Ultrasound

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

DEVICENon-active Therapeutic Ultrasound

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
skin blood flow	2 weeks

Secondary

Measure	Time frame
skin temperature	2 weeks
skin water content	2 weeks
Tactile pain threshold	2 weeks
erythema index	2 weeks
skin thickness	2 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026