CompletedNot Applicable

Effectiveness of High-Voltage PRF for Chronic Lumbosacral Radicular Pain

Indonesia22 participantsStarted 2025-02-07

Plain-language summary

This randomized controlled trial compared high-voltage (60 V) and low-voltage (45 V) pulsed radiofrequency (PRF) for treating chronic lumbosacral radicular pain in adult patients. The study evaluated differences in pain reduction (using the Visual Analogue Scale \[VAS\] and Numeric Rating Scale \[NRS-11\]), functional ability (using Oswestry Disability Index scores), serum Interleukin-6 levels, and overall safety. All participants received fluoroscopy-guided PRF at 42°C for three 120-second cycles and were followed for approximately 6 weeks.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged ≥ 18 years old * Numeric Rating Scale (NRS-11) ≥ 4 at screening * Clinical diagnosis of lumbosacral radicular pain with symptom duration ≥ 12 weeks * Insufficient response to conservative therapy, including but not limited to pharmacotherapy and/or physiotherapy Exclusion Criteria: * Known hypersensitivity or allergy to medication required during the study (e.g., steroid, contrast media) * Coagulopathy, systemic infection, localized infection at needle-entry site, lumbar fracture, myelopathy, or severe organ dysfunction (e.g., renal failure, heart failure, severe respiratory diseases) * Comorbidities that compromise valid pain assessment (e.g., post-stroke, central neuropathy, malignancy) * Previous neurological deficits * Pregnancy * Refusal of participation in the study

What they're measuring

Change from Baseline in the Numeric rating scale (NRS-11) at Follow Up

Timeframe: Baseline (pre-intervention) through study completion, an average of 6 weeks.

Change from Baseline in the Visual Analog Scale (VAS) at Follow Up

Timeframe: Baseline (pre-intervention) through study completion, an average of 6 weeks.

Trial details

NCT IDNCT07303309

SponsorHasanuddin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-29

View on ClinicalTrials.gov More Lumbosacral Radicular Pain trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline in the Numeric rating scale (NRS-11) at Follow Up

Timeframe: Baseline (pre-intervention) through study completion, an average of 6 weeks.

Change from Baseline in the Visual Analog Scale (VAS) at Follow Up

Timeframe: Baseline (pre-intervention) through study completion, an average of 6 weeks.