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| Name | Class |
|---|---|
| Faculty of Medicine, Gadjah Mada University | UNKNOWN |
| Sardjito General Hospital, Yogyakarta, Indonesia | UNKNOWN |
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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.
Consecutive patients who met the inclusion and exclusion criteria were enrolled and randomized into two groups: the intervention group (high-voltage PRF, 60 V) and the control group (low-voltage PRF, 45 V). The sample size was calculated using the Neyman-Pearson approach with a superiority hypothesis, assuming that the intervention group would achieve greater pain reduction than the control group. Accounting for an estimated 20% dropout rate, 11 participants were required per group. Patients who voluntarily withdrew from the study were excluded from analysis, whereas patients who discontinued the intervention due to adverse effects during or after the procedure were included in the analysis and reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard/Low-Voltage PRF at 45 V | Active Comparator | Pulsed Radiofrequency set the voltage at 45 V. |
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| High-Voltage PRF at 60 V | Experimental | Pulsed Radiofrequency set the voltage at 60 V. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Radiofrequency | Device | A specialist performed fluoroscopy-guided monopolar Pulsed Radiofrequency (PRF) on a prone patient using a 22-gauge cannula (Cosman CC, CR type, 10 cm with a 10 mm active tip). Sensory stimulation prior to the procedure was applied at 200 Ohm, 50 Hz (threshold: 0.3 - 0.5 V), and motor stimulation at 2 Hz (threshold: 0.9 - 1.5 V). PRF was applied at a maximum temperature of 42 centigrade, with a frequency of 2 Hz, pulse width of 20 milliseconds, and a duration of 120 seconds per cycle for three cycles. An operating room nurse set the voltage at 45 V or 60 V. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Numeric rating scale (NRS-11) at Follow Up | Zero is equivalent to no pain and 10 indicates the worst possible pain. | Baseline (pre-intervention) through study completion, an average of 6 weeks. |
| Change from Baseline in the Visual Analog Scale (VAS) at Follow Up | The Visual Analogue Scale (VAS) is determined by measuring the distance (in millimeters) from the patient's mark on a 100mm line to the left end of the line. The left endpoint is equivalent to "no pain" and right endpoint represents the "worst imaginable pain." | Baseline (pre-intervention) through study completion, an average of 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Oswestry's Disability Index Score at Follow Up | The Oswestry Disability Index (ODI) was developed to evaluate the degree of disability associated with low back pain (LBP). An increase of 10% or more from the baseline ODI score is generally considered to indicate a clinically and statistically significant change in the patient's condition. | Baseline (pre-intervention) through study completion, an average of 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Complication and Adverse Event | Any complications or adverse events that occurred during the procedure or afterward up to the follow-up period. | From enrollment through study completion, an average of 6 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farhan A Rahman, MD | RSUP Dr. Sardjito/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada | Principal Investigator |
| Nur S Wirawan, MD | Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University | Study Director |
| Muhammad R Ahmad, MD | Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSI Sultan Agung Islamic Teaching Hospital | Semarang | Central Java | 50112 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27144851 | Background | Deyo RA, Mirza SK. CLINICAL PRACTICE. Herniated Lumbar Intervertebral Disk. N Engl J Med. 2016 May 5;374(18):1763-72. doi: 10.1056/NEJMcp1512658. No abstract available. | |
| 37976483 | Background | Jang JN, Park S, Park JH, Song Y, Kim YU, Kim DS, Sohn JE, Park S. Output Current and Efficacy of Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion in Patients With Lumbar Radiculopathy: A Prospective, Double-blind, Randomized Pilot Study. Pain Physician. 2023 Nov;26(7):E797-E804. |
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Individual participant data (IPD) underlying the results presented in future publication will be made available to facilitate additional research in this area. Excluding identifiers -such as names, addresses, and medical record numbers.
The IPD will be available for 5 years, starting immediately after publication.
The IPD will be accessible to all individuals who have access to the Google Drive link provided in the publication.
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| ID | Term |
|---|---|
| D061208 | Pulsed Radiofrequency Treatment |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D000078702 | Radiofrequency Therapy |
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Standard/Low-voltage pulsed radiofrequency (45V) was compared with high-voltage pulsed radiofrequency (60 V)
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| Post-operative Analgesia | Drug | Post-procedure analgesia in both groups was provided via IV fentanyl 0.5-1 µg/kg, administered as needed for patients reporting an NRS score greater than 4. This intervention was not a primary focus of the study. |
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| Change from Baseline in Serum Interleukin-6 at Follow Up | A reduction or maintenance of serum interleukin-6 levels from baseline at follow-up. | Baseline (pre-intervention) through study completion, an average of 6 weeks. |
| 36463027 | Background | Erken B, Edipoglu IS. Efficacy of High-Voltage Pulsed Radiofrequency of the Dorsal Root Ganglion for Treatment of Chronic Lumbosacral Radicular Pain: A Randomized Clinical Trial. Neuromodulation. 2024 Jan;27(1):135-140. doi: 10.1016/j.neurom.2022.10.056. Epub 2022 Dec 1. |
| D012046 | Rehabilitation |