UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008669 |
|---|---|
| Receipt number | R000010161 |
| Scientific Title | Effects of paravertebral massage on autonomic nerve - A randomized controlled trial - |
| Date of disclosure of the study information | 2012/08/10 |
| Last modified on | 2016/02/19 10:07:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of paravertebral massage on autonomic nerve - A randomized controlled trial -
Acronym
Effects of paravertebral massage
Scientific Title
Effects of paravertebral massage on autonomic nerve - A randomized controlled trial -
Scientific Title:Acronym
Effects of paravertebral massage
Region
| Japan |
Condition
Condition
Normal subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of paravertebral massage on autonomic nerve.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
autonomic nerve function
Key secondary outcomes
POMS, check of brain fatigue, questionnaire of mood check, plasmalogen
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Paravertebral massage is practiced on the bed
Interventions/Control_2
No pararavertebral massage but rest is practiced on the bed
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Persons who take sufficient explanations on the trial and give an agreement in written form. In cases under 20 years old, persons whose parents or protectors give agreement an agreement .
2.Persons whose age are 18 to 70 years old.
3.Persons who have brain fatigue.
4.Persons who give the picture by thermography and permit the advertisement
Key exclusion criteria
1.Persons who have taken part in the other clinical trial within a month before the beginning of this trial
2.Persons who have ever taken the paravertebral massage before the trial
3.Persons who may get pregnant or are pregnant or are lactating
4.Persons who may exchange the use or dosages of drugs or functional food which are influential for the clinical results
5.Persons who were judged unqualified by the doctor in charge
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiko Fujino |
Organization
BOOCS Medical Corporation
Division name
Director
Zip code
Address
6-18-6F,Tenyamachi, Hakata-ku, Fukuoka-shi Fukuoka 812-0025 Japan
TEL
092-283-6852
fujino-t@boocsclinic.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikako Wakana |
Organization
BOOCS Medical Corporation
Division name
BOOCS Clinic Fukuoka
Zip code
Address
6-18-6F,Tenyamachi, Hakata-ku, Fukuoka-shi Fukuoka 812-0025 Japa
TEL
092-283-6852
Homepage URL
fujino-t@boocsclinic.com
Sponsor or person
Institute
Bioennet corporation
Institute
Department
Personal name
Funding Source
Organization
EBM corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 08 | Month | 10 | 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
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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 10 | Day |
Last modified on
| 2016 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010161
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
