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Completed

NCT Number: NCT02257281

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

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Therapeutic Ultrasound

Device

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

Non-active Therapeutic Ultrasound

Device

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

Primary outcomes

  1. skin blood flow

    Time frame: 2 weeks

Secondary outcomes

  1. skin temperature

    Time frame: 2 weeks

  2. skin water content

    Time frame: 2 weeks

  3. Tactile pain threshold

    Time frame: 2 weeks

  4. erythema index

    Time frame: 2 weeks

  5. skin thickness

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Chung Shan Medical University Hospital Institutional Review Board

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2014
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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