UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004956
Receipt number R000005656
Scientific Title Effect of teraseal for stiff shoulders
Date of disclosure of the study information 2011/01/26
Last modified on 2013/11/18 15:24:47

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Basic information

Public title

Effect of teraseal for stiff shoulders

Acronym

Effect of teraseal

Scientific Title

Effect of teraseal for stiff shoulders

Scientific Title:Acronym

Effect of teraseal

Region

Japan


Condition

Condition

stiff shoulders

Classification by specialty

Medicine in general Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this trial is to investigate a relaxation effect of teraseal (terhertz-emitting seal) against stiff shoulders. In general unhealthy livings and decayed plants and fruits have lower radiation dosage and average emissivity of incoherent terahertz waves because of disturbed lattice vibration of constituent molecules. Terhertz-emitting seals treated by strong terahertz wave in advance and those without treatment are randomly applied for men and women with stiff shoulders, and a relaxation effect of terhertz-emitting seal is evaluated against stiff shoulders under double blind randomized method.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Relaxation effect against stiff shoulders by a teraseal (terhertz-emitting seal) which radiates incoherent terahertz wave.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The purpose of this trial is to investigate a relaxation effect of a teraseal (terahertz-emitting seal) against stiff shoulders.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

men and women with stiff shoulders

Key exclusion criteria

men and women without stiff shoulders

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Shima, M.D. Ph.D.

Organization

The SHIMA Institution for Quantum Medicine

Division name

Division of Clinical Trial

Zip code


Address

3-7-41-401 Nakatsu, Kitaku, Osaka, JAPAN 531-0071

TEL

+81-6-6372-8755

Email

shima@siqm.org


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Shima, M.D. Ph.D.

Organization

The SHIMA Institution for Quantum Medicine

Division name

Division of Clinical Trial

Zip code


Address

3-7-41-401 Nakatsu, Kitaku, Osaka, JAPAN 531-0071

TEL

+81-6-6372-8755

Homepage URL


Email

shima@siqm.org


Sponsor or person

Institute

The SHIMA Institution for Quantum Medicine

Institute

Department

Personal name



Funding Source

Organization

The SHIMA Institution for Quantum Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2011 Year 01 Month 26 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

The report of a double-blind,
Randomized, Placebo-Controlled Trial of Terahertz wave-emitting seal.

The SHIMA Institution for Quantum Medicine
Director Hiroki Shima, M.D.Ph.D


Summary

The Double-blind, Randomized, Placebo-Controlled Trial of Terahertz wave-emitting and control seal against stiff shoulder was performed in 150 test subjects.
Both Terahertz wave-emitting and control seal groups showed significantly relaxation effects for stiff shoulders before and after patching seals on their shoulders for 5 minutes.
The NES (numerical evaluation scale for stiff shoulder) sensational intensity was converted to the rank of stimulus intensity using Weber-Fechner law. Ranking of stimulus intensity was analyzed by Wilcoxon rank sum test. The result showed that the relaxation effects for the stiff shoulders were significant before and after patching Terahertz wave-emitting seals on their shoulders. In female group (24 females), the relaxation effect of Terahertz wave-emitting seals on their stiff shoulders were statistically significant in comparison with that of control seals patched in the same way (p < 0.05).
In both male and total group, the relaxation effects by Terahertz wave-emitting seal were significantly recognized, but there were no statistical difference about the relaxation effects for the stiff shoulders between Terahertz wave-emitting seal and control groups.
In conclusion, Terahertz wave-emitting seals rendered test subjects the relaxation effects for their stiff shoulders.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2010 Year 12 Month 13 Day

Date of IRB


Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date

2011 Year 05 Month 01 Day

Date of closure to data entry

2011 Year 05 Month 01 Day

Date trial data considered complete

2011 Year 06 Month 01 Day

Date analysis concluded

2011 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 01 Month 26 Day

Last modified on

2013 Year 11 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005656


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name