InflammationNCT02257281
The Effect of Therapeutic Ultrasound on Soft Tissue: An Experimentally-induced Skin Model
A study testing Active Therapeutic Ultrasound and Non-active Therapeutic Ultrasound in people with Inflammation, run by Chung Shan Medical University.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Active Therapeutic Ultrasound and Non-active Therapeutic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- asia healthy subjects
- aged 20-45 years
Who cannot join
- 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
About this study
Official title: Chung Shan Medical University Hospital Institutional Review Board
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.
Read the 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.
- Conditions
- Inflammation
- Being tested
- Active Therapeutic Ultrasound, Non-active Therapeutic Ultrasound
- Keywords
- Sodium lauryl sulfate, Skin irritants, inflammation, therapeutic ultrasound
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Therapeutic UltrasoundDevice
For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.
Non-active Therapeutic UltrasoundDevice
For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.
| Study group | Role | What they receive |
|---|---|---|
| Active Therapeutic Ultrasound | Experimental | 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 . Receives: Device: Active Therapeutic Ultrasound |
| Non-active Therapeutic Ultrasound | Placebo comparator | The contralateral three inflammatory forearm spots induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with non-active therapeutic ultrasound . Receives: Device: Non-active Therapeutic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin blood flow
Measured: 2 weeks
Secondary outcomes (5)
skin temperature
Measured: 2 weeks
skin water content
Measured: 2 weeks
Tactile pain threshold
Measured: 2 weeks
erythema index
Measured: 2 weeks
skin thickness
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GCRC, Chung Shan Medical University
- Investigators
- Peir Renn Wang, MD, Principal investigator, Department of rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257281
- Sponsor's protocol ID
- CS14008
- Status last verified
- Dec 2015
- First submitted
- 2 Oct 2014
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chung Shan Medical University Hospital Institutional Review Board
- ClinicalTrials.gov ID
- NCT02257281
- Acronym / sponsor ID
- CS14008
- Conditions
- Inflammation
- Keywords
- Sodium lauryl sulfate, Skin irritants, inflammation, therapeutic ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Therapeutic Ultrasound | Experimental | Device: Active Therapeutic UltrasoundThe three inflammatory forearm spots on the same side induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with active therapeutic ultrasound . |
| Non-active Therapeutic Ultrasound | Placebo comparator | Device: Non-active Therapeutic UltrasoundThe contralateral three inflammatory forearm spots induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with non-active therapeutic ultrasound . |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- asia healthy subjects
- aged 20-45 years
Key exclusion criteria (8 listed)
- disadvantaged groups
- systemic disease, such as DM, cancer, autoimmune disorder
- hyperhidrosis or hypothyroidism
- a past history of dermatitis
- active infective or inflammatory cutaneous disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Therapeutic UltrasoundFor Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days. | Device | Active Therapeutic Ultrasound |
| Non-active Therapeutic UltrasoundFor Placebo group: The non-active therapeutic ultrasound was applied each spot for several days. | Device | Non-active Therapeutic Ultrasound |
Primary outcome
skin blood flow
Time frame: 2 weeks
5 secondary outcomes
skin temperature
Time frame: 2 weeks
skin water content
Time frame: 2 weeks
Tactile pain threshold
Time frame: 2 weeks
erythema index
Time frame: 2 weeks
skin thickness
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peir Renn Wang, MD principal investigator
Department of rehabilitation
Questions about this trial
What is this clinical trial studying?
A study testing Active Therapeutic Ultrasound and Non-active Therapeutic Ultrasound in people with Inflammation, run by Chung Shan Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin blood flow (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.