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Study of the effect of cooled saline infusion on electrical output during pulsed radiofrequency treatment

Measurement of Output Changes Induced by Continuous Infusion of Cooled Saline During Pulsed Radiofrequency Treatment - Cooled Continuous saline PRF output study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061113
Enrollment
16
Registered
2026-03-31
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radicular pain due to lumbar disc herniation, lumbar spinal canal stenosis, or related conditions

Interventions

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, &lt
=0.5 mL/min, total &lt
=1.5 mL).

Sponsors

Nagaski Rosai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Mean electrical power output (W) during each 3-minute phase

Secondary

MeasureTime frame
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.)

Countries

Japan

Contacts

Public ContactMakito Oji

Nagasaki Rosai Hospital Department of Anesthesiology

callme_jo6ptj@yahoo.co.jp0956-49-2191

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026