Effectiveness of High-Voltage PRF for Chronic Lumbosacral Radicular Pain
CompletedNot applicableNCT07303309
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effectiveness of High-Voltage Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain: A Randomized Controlled Trial
- Conditions
- Lumbosacral Radicular Pain
- Chronic Radicular Back Pain
- Interventions
- Device: Pulsed Radiofrequency
- Drug: Post-operative Analgesia
- Sponsor
- Hasanuddin University
- Collaborators
- Faculty of Medicine, Gadjah Mada University; Sardjito General Hospital, Yogyakarta, Indonesia
- Start date
- 2025-02-07
- Primary completion
- 2025-04-29
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Indonesia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07303309