UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059062 |
|---|---|
| Receipt number | R000067560 |
| Scientific Title | Sustained Effects of High-Voltage Treatment on the Psoas Muscle in Patients with Acute Low Back Pain |
| Date of disclosure of the study information | 2025/09/15 |
| Last modified on | 2025/09/11 19:21:30 |
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Basic information
Public title
Sustained Effects of High-Voltage Treatment on the Psoas Muscle in Patients with Acute Low Back Pain
Acronym
Sustained Effects of High-Voltage Treatment on the Psoas Muscle in Patients with Acute Low Back Pain
Scientific Title
Sustained Effects of High-Voltage Treatment on the Psoas Muscle in Patients with Acute Low Back Pain
Scientific Title:Acronym
Sustained Effects of High-Voltage Treatment on the Psoas Muscle in Patients with Acute Low Back Pain
Region
| Japan |
Condition
Condition
Acute low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the sustained efficacy of high-voltage pulsed current therapy applied to the iliopsoas muscle in improving low back pain among patients with acute low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Rating Scale (NRS) before and after treatment, and up to 3 days after treatment
Key secondary outcomes
Pelvic tilt angle before and after treatment and three days later
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
While lying on your back, apply high-voltage treatment to left and right psoas muscles for 5minutes (130Hz x 3minutes, 5Hz x 2minutes) per session.
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Severe low back pain during activities of daily living
Acute low back pain lasting less than 4 weeks
Aged 18 to 80 years
Moderate pain rated 4 or higher on the Numerical Rating Scale (NRS)
Key exclusion criteria
Waseda University undergraduate and graduate students
Patients with conditions presumed to be specific low back pain
Patients with clearly identifiable traumatic causes of injury
Patients with dementia
Patients with specific implanted electronic devices such as pacemakers
Patients with acute (painful) conditions of unknown cause
Patients with cardiac impairment
Patients with high bleeding risk
Patients with malignant tumors
Patients with febrile illnesses
Patients with infectious diseases
Pregnant women or women who have recently given birth
Patients at risk of vascular disorders such as thrombosis, venous thrombosis, or varicose veins
Other patients deemed unsuitable by the physician
Ischemic tissue
Areas with moderate or severe edema
Areas with sensory impairment
Skin damage or inflamed areas
Skin surfaces with venous distension (where veins are prominent)
Areas with implanted metal or plastic objects (e.g., artificial joints, buried pins)
Above the carotid sinus
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Oka |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1164
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
042-947-7189
koka@waseda.jp
Public contact
Name of contact person
| 1st name | Ryujo |
| Middle name | |
| Last name | Hadano |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1164
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
090-9137-4279
Homepage URL
hadanodesu@akane.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University Research Promotion Division Research Management Section
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo 169-8050
Tel
03-5272-4652
rps-management@list.waseda.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 | 09 | Month | 15 | 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067560
