Chronic Radicular Back Pain, Lumbosacral Radicular Pain
Conditions
Keywords
pain measurement, high-voltage, pulsed radiofrequency, chronic lumbosacral radicular pain, visual analogue pain scale
Brief 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.
Detailed description
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.
Interventions
DEVICEPulsed Radiofrequency
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.
DRUGPost-operative Analgesia
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.
Sponsors
Faculty of Medicine, Gadjah Mada University
Sardjito General Hospital, Yogyakarta, Indonesia
Hasanuddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Standard/Low-voltage pulsed radiofrequency (45V) was compared with high-voltage pulsed radiofrequency (60 V)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Numeric rating scale (NRS-11) at Follow Up | Baseline (pre-intervention) through study completion, an average of 6 weeks. | Zero is equivalent to no pain and 10 indicates the worst possible pain. |
| Change from Baseline in the Visual Analog Scale (VAS) at Follow Up | Baseline (pre-intervention) through study completion, an average of 6 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Oswestry's Disability Index Score at Follow Up | Baseline (pre-intervention) through study completion, an average of 6 weeks. | 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. |
| Change from Baseline in Serum Interleukin-6 at Follow Up | Baseline (pre-intervention) through study completion, an average of 6 weeks. | A reduction or maintenance of serum interleukin-6 levels from baseline at follow-up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complication and Adverse Event | From enrollment through study completion, an average of 6 weeks. | Any complications or adverse events that occurred during the procedure or afterward up to the follow-up period. |
Countries
Indonesia
Outcome results
None listed