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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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.