UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061113 |
|---|---|
| Receipt number | R000069935 |
| Scientific Title | Measurement of Output Changes Induced by Continuous Infusion of Cooled Saline During Pulsed Radiofrequency Treatment |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/03/31 14:02:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of the effect of cooled saline infusion on electrical output during pulsed radiofrequency treatment
Acronym
Cooled Continuous saline PRF output study
Scientific Title
Measurement of Output Changes Induced by Continuous Infusion of Cooled Saline During Pulsed Radiofrequency Treatment
Scientific Title:Acronym
Cooled Continuous saline PRF output study
Region
| Japan |
Condition
Condition
Radicular pain due to lumbar disc herniation, lumbar spinal canal stenosis, or related conditions
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether continuous infusion of cooled saline during pulsed radiofrequency (PRF) treatment alters the mean electrical power output (W) within the same procedure in lumbar and sacral nerve root blocks.
Secondary outcomes include impedance changes, temperature-related parameters, and safety outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean electrical power output (W) during each 3-minute phase
Key secondary outcomes
Change in impedance (ohm)
Temperature parameters (mean, peak, change)
Time to maximum power
Patient-reported outcomes (procedural pain NRS)
Adverse events (abnormal pain, excessive motor response, vasovagal reaction, hematoma, etc.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Within the same nerve root block procedure, the first 3 minutes are performed without saline infusion, followed by 3 minutes with continuous infusion of cooled saline (4 to 8 degrees Celcius, <=0.5 mL/min, total <=1.5 mL).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged (18 years or more)
Chronic pain clinically diagnosed as radicular pain due to lumbar disc herniation, spinal stenosis, or similar conditions
Indicated for lumbar or sacral nerve root block
Able to understand the study and provide written informed consent
Key exclusion criteria
Local or systemic infection
Severe bleeding tendency or inability to discontinue anticoagulants
Allergy to local anesthetics or contrast agents
Severe arrhythmia
Non-radicular pain
Severe spinal deformity or post-surgical changes impairing reproducibility
Inability to understand or consent
Cases deemed inappropriate by the investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Makito |
| Middle name | |
| Last name | Oji |
Organization
Nagasaki Rosai Hospital
Division name
Department of Anesthesiology
Zip code
857-0134
Address
2-12-5, Setogoe, Sasebo, Nagasaki
TEL
0956-49-2191
callme_jo6ptj@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Makito |
| Middle name | |
| Last name | Oji |
Organization
Nagasaki Rosai Hospital
Division name
Department of Anesthesiology
Zip code
857-0134
Address
2-12-5, Setogoe, Sasebo, Nagasaki
TEL
0956-49-2191
Homepage URL
callme_jo6ptj@yahoo.co.jp
Sponsor or person
Institute
Nagaski Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagaski Rosai Hospital
Address
2-12-5, Setogoe, Sasebo, Nagasaki
Tel
0956-49-2191
callme_jo6ptj@yahoo.co.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 | 03 | Month | 31 | 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
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | 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 | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069935
