UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057628 |
|---|---|
| Receipt number | R000065839 |
| Scientific Title | Effects of high-frequency electrical stimulation on autonomic nervous system response to low back pain syndrome |
| Date of disclosure of the study information | 2025/04/16 |
| Last modified on | 2025/04/16 13:55:42 |
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Basic information
Public title
Does Thermotherapy for Low Back Pain Syndrome Affect the Autonomic Nervous System?
Acronym
Effects of Thermotherapy on Low Back Pain Syndrome
Scientific Title
Effects of high-frequency electrical stimulation on autonomic nervous system response to low back pain syndrome
Scientific Title:Acronym
Effects of Thermal Stimulation on the Autonomic Nervous System for Low Back Pain Syndrome
Region
| Japan |
Condition
Condition
Low back pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effects of 448 kHz thermal stimulation on autonomic responses in individuals with low back pain or previous low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For the autonomic nervous system evaluation, a small heart rate monitor My Beat was attached to the chest during the above three interventions, and the heart rate variability obtained during the interventions was analyzed by RRI Analyzer to determine the Low Frequency/High Frequency and High Frequency changes over time are recorded.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The irradiation range for 448 kHz thermal stimulation was from the fourth thoracic spinous process to 5 cm on either side of the twelfth thoracic spinous process, where many sympathetic ganglia that run parallel to the spine and are involved in stress responses are located. The irradiation duration is 15 minutes. The irradiation intensity is adjusted on a score of 5 to 7 using an 11-point analog scale on which subjects self-report heat sensation according to the safety procedures recommended by Indaba.
Interventions/Control_2
When using hot packs, the hot packs should not be applied directly to the skin, but should be heated indirectly by using towels or other means according to the manufacturer's instructions to prevent burns or other skin damage.
Interventions/Control_3
The range of intervention and duration of hot packs and pseudothermal stimulation should also be the same.
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
| 25 | years-old | > |
Gender
Male
Key inclusion criteria
Sports enthusiasts who currently have low back pain or have a history of low back pain in the past 6 months or less.
Key exclusion criteria
Those who have been diagnosed with back pain more than 6 months ago, those with a history of spinal surgery, those with a history of cerebrovascular disease, those with superficial sensory disturbance, those with a history of autonomic imbalance, etc., and those with a history of psychosomatic medicine visits. Those with hypertension or hypotension. Those with specific or suspected cardiac disease, or those otherwise judged by a physician to have difficulty participating in the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Miyamori |
Organization
Juntendo University
Division name
Graduate School of Health Science
Zip code
1138421
Address
1-1 Hongo Bunkyo-ku Tokyo JAPAN
TEL
0338133111
t.miyamori.hi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | takayuki |
| Last name | Miyamori |
Organization
Juntendo University
Division name
Graduate School of Health Science
Zip code
1138421
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
0338133111
Homepage URL
t.miyamori.hi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
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
Juntendo University
Address
2-1-1 Hongo Bunkyo-ku Tokyo
Tel
0338133111
t.miyamori.hi@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 16 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 16 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065839
