UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033913 |
|---|---|
| Receipt number | R000038660 |
| Scientific Title | Elucidation of neuronal mechanisms for massage therapy. |
| Date of disclosure of the study information | 2018/08/27 |
| Last modified on | 2019/04/17 10:58:41 |
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Basic information
Public title
Elucidation of neuronal mechanisms for massage therapy.
Acronym
Elucidation of neuronal mechanisms for massage therapy.
Scientific Title
Elucidation of neuronal mechanisms for massage therapy.
Scientific Title:Acronym
Elucidation of neuronal mechanisms for massage therapy.
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to investigate the effect of compression at myofascial trigger points in patients with low back pain on hemodynamic response and electrical activity in the brain using a near infrared spectroscopy (NIRS) and an electroencephalogram (EEG).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective feeling of pain score (Visual Analog Scale: VAS)
Key secondary outcomes
Near Infrared Spectroscopy (NIRS)
Electroencephalogram (EEG)
Pressure Pain Thereshold
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Compression at myofascial trigger point
Interventions/Control_2
Compression at non-trigger point
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Subjects who complain of low back pain.
2)Subjects who had myofascial trigger points on quadratus lumborum muscle.
Key exclusion criteria
1) Patients with The past history of spinal surgery.
2) Patients with spinal fracture or dislocation.
3) Patients with neurological signs.
4) Patients with analgesics
5) Patients with complain of systemic pain, or those with a history of rheumatoid arthritis, metastasis such as tumor, fibromyalgia,Tumors of the spine or intervertebral disc, infections, or other diseases responsible for systemic pain.
6) Pregnant patients.
7) Patients who received treatments such as massage, acupuncture, never block, etc, for their back pain at other hospitals or clinics within 1 month from the start of the study.
8) Patients with a history of whiplash injury due to traffic accidents.
9) Patients whom are recognized as inadequate subjects by the experimenters.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichi Takamoto |
Organization
University of Toyama
Division name
Department of system emotional science
Zip code
Address
2630, Sugitani, Toyama, Japan
TEL
076-434-7218
ktakamo@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouich Takamoto |
Organization
University of Toyama
Division name
Department of system emotional science
Zip code
Address
2630, Sugitani, Toyama, Japan
TEL
076-434-7218
Homepage URL
ktakamo@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
1)Grants-in-Aid for Scientific Research
2)University of Toyama
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2018 | Year | 08 | Month | 27 | 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
| 2018 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 27 | Day |
Last modified on
| 2019 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038660
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
