UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058681 |
|---|---|
| Receipt number | R000067098 |
| Scientific Title | Effects of Trunk Training Combined with Radial Extracorporeal Pressure Wave Therapy on Lumbar Erector Spinae Muscle Stiffness |
| Date of disclosure of the study information | 2025/08/03 |
| Last modified on | 2025/08/03 10:35:52 |
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Basic information
Public title
Effects of Trunk Training Combined with Extracorporeal Shock Waves on Back Muscle Stiffness
Acronym
Effects of Trunk Training with Extracorporeal Shock Waves on Back Muscle Stiffness
Scientific Title
Effects of Trunk Training Combined with Radial Extracorporeal Pressure Wave Therapy on Lumbar Erector Spinae Muscle Stiffness
Scientific Title:Acronym
Effects of Trunk Training Using Radial Extracorporeal Pressure Wave on Lumbar Erector Spinae Muscle Stiffness
Region
| Japan |
Condition
Condition
Low back pain and healthy individuals
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of Trunk Training combined with radial extracorporeal pressure waves on muscle stiffness of lumbar erector spinae muscles
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Erector spinae muscle stiffness by ultrasound
Key secondary outcomes
Degree of pain
Range of motion of lumbar flexion
Electromyography of erector spinae muscles (flexion-relaxation phenomenon)
Lumbar pressure pain threshold
Heart rate variability (LF, HF)
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Radial extracorporeal pressure wave therapy + Trunk Training
Interventions/Control_2
Trunk Training
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
University students with chronic low back pain for more than 3 months or healthy university students
Key exclusion criteria
Acute low back pain for less than 3 months, those with deformity, history of deformity or surgery with significant limitation of lumbar hip motion, those with motor dysfunction such as paralysis due to cerebrovascular disease, those who cannot understand methods, etc. due to cognitive decline, etc., and those who are pregnant.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Miyachi |
Organization
Hokuriku University
Division name
Faculty of Medical and Health Sciences
Zip code
9201180
Address
1-1 Taiyogaoka, Kanazawa, Ishikawa
TEL
076-229-1161
ry_miyachi@hokuriku-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Miyachi |
Organization
Hokuriku University
Division name
Faculty of Medical and Health Sciences
Zip code
9201180
Address
1-1 Taiyogaoka, Kanazawa, Ishikawa
TEL
09020909720
Homepage URL
ry_miyachi@hokuriku-u.ac.jp
Sponsor or person
Institute
Hokuriku University
Institute
Department
Personal name
Funding Source
Organization
Hokuriku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokuriku University Ethics Committee on Research Involving Human Subjects
Address
1-1 Taiyogaoka, Kanazawa, Ishikawa
Tel
0762296111
syakairenkei@hokuriku-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
石川県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 03 | 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
| 2025 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 03 | 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 | 08 | Month | 03 | Day |
Last modified on
| 2025 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067098
