UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047078 |
|---|---|
| Receipt number | R000053699 |
| Scientific Title | Analgesic effects of somatosensory stimuli with different vibration frequencies |
| Date of disclosure of the study information | 2022/03/04 |
| Last modified on | 2023/03/07 13:57:34 |
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Basic information
Public title
Analgesic effects of somatosensory stimuli with different vibration frequencies
Acronym
Analgesic effects of somatosensory stimuli with different vibration frequencies
Scientific Title
Analgesic effects of somatosensory stimuli with different vibration frequencies
Scientific Title:Acronym
Analgesic effects of somatosensory stimuli with different vibration frequencies
Region
| Japan |
Condition
Condition
Neck pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to effect vibration stimulation at myofascial trigger points with different frequencies for neck pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale
Key secondary outcomes
Pressure pain Threshold
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
High frequency vibration stimulation
Interventions/Control_2
Middle frequency vibration stimulation
Interventions/Control_3
Low frequency vibration stimulation
Interventions/Control_4
Control
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 neck pain.
2) Subjects who have myofascial trigger point(s) in the trapezius muscle.
Key exclusion criteria
1)Subjects with the past history of spinal surgery.
2) Subjects with spinal fracture or dislocation.
3)Subjects with neurological sings
4)Subjects with analgesics.
5) Subjects 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)Subjects with heart disease.
7)Subjects with active implantable medical devices such as pacemakers.
8)Subjects with severe hematogenous disorder.
9)Subjects with sensory abnormality caused by peripheral circulatory disturbances such as diabetes.
10) Subjects with balance disorders
11) Pregnant subjects.
12) Subjects who received treatments such as massage, acupuncture, nerve block, etc, whthin 1 month from the start of the study.
13)Subjects with a history of whiplash injury due to traffic accidents.
14) Subjects whom are recognized as inadequate subjects by the experimenters.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | kouichi |
| Middle name | |
| Last name | Takamoto |
Organization
University of East Asia
Division name
Department of sport and Health Sciences, Faculty of Human Sciences
Zip code
751-8503
Address
2-1 Ichinomiya Gakuencho, Shimonoseki City, Yamaguchi Prefecture
TEL
083-256-1111
ktakamo@toua-u.ac.jp
Public contact
Name of contact person
| 1st name | Kouichi |
| Middle name | |
| Last name | Takamoto |
Organization
University of East Asia
Division name
Department of sport and health Science, Faculty of Human Sciences
Zip code
751-8503
Address
2-1 Ichinomiya Gakuencho, Shimonoseki City, Yamaguchi Prefecture
TEL
083-256-1111
Homepage URL
ktakamo@toua-u.ac.jp
Sponsor or person
Institute
University of East Asia
Institute
Department
Personal name
Funding Source
Organization
Dream factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Toyama
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of East Asia University
Address
2-1 Ichinomiya Gakuencho, Shimonoseki City, Yamaguchi Prefecture
Tel
083-256-1111
kyomushitsu@toua-u.ac.jp
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
東亜大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053699
