UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061210 |
|---|---|
| Receipt number | R000070039 |
| Scientific Title | Effectiveness of Radiofrequency versus Ultrasound on Non-specific Chronic Low Back Pain: A Randomized Crossover Study |
| Date of disclosure of the study information | 2026/04/09 |
| Last modified on | 2026/04/09 10:18:50 |
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Basic information
Public title
Effectiveness of Radiofrequency versus Ultrasound on Non-specific Chronic Low Back Pain
Acronym
Radiofrequency versus Ultrasound application for Non-specific Chronic Low Back Pain
Scientific Title
Effectiveness of Radiofrequency versus Ultrasound on Non-specific Chronic Low Back Pain: A Randomized Crossover Study
Scientific Title:Acronym
Radiofrequency versus Ultrasound application for Non-specific Chronic Low Back Pain
Region
| Japan |
Condition
Condition
Non-specific Chronic Low Back Pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This aim of this study is to evaluate the immediate effects of radiofrequency (RF) versus therapeutic ultrasound (US) in improving pain and muscle stiffness as well as in normalizing muscle activity during maximum standing forward trunk flexion and the flexion relaxition phenomenon (FRP) among patients with nonspecific chronic low back pain (NSCLBP).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle stiffness of multifidus and erector spinae
Key secondary outcomes
Range of motion of lumber spine during extension and full flexion phase, muscle activity using Electromyography, and Pain
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Radiofrequency
Interventions/Control_2
Therapeutic ultrasound
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persistent chronic nonspecific low back pain for three months.
Key exclusion criteria
- If they exhibit any neurological symptoms.
- If the subject has a history of surgery and trauma to the neck and back within the past 12 months.
- Contraindications and precautions to heating modalities.
- If subject using any medication.
- If the subject has skin infection.
- Disc prolapse, nerve root compression, spinal canal stenosis, tumor and spondylolisthesis
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Usa |
Organization
Tokyo Metropolitan University, Tokyo, Japan
Division name
Faculty of Health Sciences, Division of Physical Therapy
Zip code
1168551
Address
7-2-10 Higashi-ogu, Arakawa-ku, Tokyo
TEL
+81-3-3819-1211
usa@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Usa |
Organization
Tokyo Metropolitan University, Tokyo, Japan
Division name
Faculty of Health Sciences, Division of Physical Therapy
Zip code
1168551
Address
7-2-10 Higashi-ogu, Arakawa-ku, Tokyo
TEL
+81-3-3819-1211
Homepage URL
usa@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokyo Metropolitan University Arakawa Campus
Address
7-2-10 Higashi-ogu, Arakawa-ku, Tokyo 116-8551, Japan
Tel
+81-3-3819-1211
a-rinri@jmj.tmu.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
| 2026 | Year | 04 | Month | 09 | 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
24
Results
The results will be published in peer-reviewed journal. The update will be provided here after publication. Expected publication time is December 2026.
Results date posted
| 2026 | Year | 04 | Month | 09 | Day |
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070039
