Lumbosacral Radicular PainNCT07303309
Effectiveness of High-Voltage PRF for Chronic Lumbosacral Radicular Pain
A study testing Pulsed Radiofrequency and Post-operative Analgesia in people with Lumbosacral Radicular Pain and Chronic Radicular Back Pain, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbosacral Radicular Pain, Chronic Radicular Back Pain
- What is being tested?
- Pulsed Radiofrequency and Post-operative Analgesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Feb 2025to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSI Sultan Agung Islamic Teaching Hospital
Semarang, Central Java, 50112
About this study
Official title: Effectiveness of High-Voltage Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Pulsed Radiofrequency, Post-operative Analgesia
- Keywords
- pain measurement, high-voltage, pulsed radiofrequency, chronic lumbosacral radicular pain, visual analogue pain scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed RadiofrequencyDevice
Also called PRF
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.
Post-operative AnalgesiaDrug
Also called Rescue Analgesia, Post-operative opioid
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard/Low-Voltage PRF at 45 V | Active comparator | Pulsed Radiofrequency set the voltage at 45 V. Receives: Device: Pulsed Radiofrequency; Drug: Post-operative Analgesia |
| High-Voltage PRF at 60 V | Experimental | Pulsed Radiofrequency set the voltage at 60 V. Receives: Device: Pulsed Radiofrequency; Drug: Post-operative Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: Baseline (pre-intervention) through study completion, an average of 6 weeks.
Secondary outcomes (2)
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.
Measured: Baseline (pre-intervention) through study completion, an average of 6 weeks.
Change from Baseline in Serum Interleukin-6 at Follow Up
A reduction or maintenance of serum interleukin-6 levels from baseline at follow-up.
Measured: Baseline (pre-intervention) through study completion, an average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start7 Feb 2025
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbosacral Radicular PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Standard/Low-voltage pulsed radiofrequency (45V) was compared with high-voltage pulsed radiofrequency (60 V)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Medicine, Gadjah Mada University, Sardjito General Hospital, Yogyakarta, Indonesia
- Responsible party
- Principal investigator, dr. Farhan Ali Rahman, Sp. An-T.I., F.I.P., Gadjah Mada University
- Investigators
- Farhan A Rahman, MD, Principal investigator, RSUP Dr. Sardjito/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah MadaNur S Wirawan, MD, Study director, Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin UniversityMuhammad R Ahmad, MD, Study director, Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303309
- Sponsor's protocol ID
- 28/KEPK-RSISA/I/2025
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27144851Jang 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.
PubMed 37976483Erken 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.
PubMed 36463027
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-Voltage Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07303309
- Acronym / sponsor ID
- 28/KEPK-RSISA/I/2025
- Keywords
- pain measurement, high-voltage, pulsed radiofrequency, chronic lumbosacral radicular pain, visual analogue pain scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Collaborators
- Faculty of Medicine, Gadjah Mada University, Sardjito General Hospital, Yogyakarta, Indonesia
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Standard/Low-voltage pulsed radiofrequency (45V) was compared with high-voltage pulsed radiofrequency (60 V)
| Arm | Type | Receives |
|---|---|---|
| Standard/Low-Voltage PRF at 45 V | Active comparator | Device: Pulsed Radiofrequency, Drug: Post-operative AnalgesiaPulsed Radiofrequency set the voltage at 45 V. |
| High-Voltage PRF at 60 V | Experimental | Device: Pulsed Radiofrequency, Drug: Post-operative AnalgesiaPulsed Radiofrequency set the voltage at 60 V. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed RadiofrequencyAlso: PRFA 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. | Device | High-Voltage PRF at 60 V, Standard/Low-Voltage PRF at 45 V |
| Post-operative AnalgesiaAlso: Rescue Analgesia, Post-operative opioidPost-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. | Drug | High-Voltage PRF at 60 V, Standard/Low-Voltage PRF at 45 V |
Primary outcome
Change from Baseline in the Numeric rating scale (NRS-11) at Follow Up
Time frame: 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
Time frame: 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."
2 secondary outcomes
Change from Baseline in Oswestry's Disability Index Score at Follow Up
Time frame: Baseline (pre-intervention) through study completion, an average of 6 weeks.
Change from Baseline in Serum Interleukin-6 at Follow Up
Time frame: Baseline (pre-intervention) through study completion, an average of 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 27144851Deyo 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.
- Background: PubMed 37976483Jang 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.
- Background: PubMed 36463027Erken 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farhan A Rahman, MD principal investigator
RSUP Dr. Sardjito/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada
Nur S Wirawan, MD study director
Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University
Muhammad R Ahmad, MD study director
Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency and Post-operative Analgesia in people with Lumbosacral Radicular Pain and Chronic Radicular Back Pain, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Numeric rating scale (NRS-11) at Follow Up (time frame: Baseline (pre-intervention) through study completion, an average of 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07303309, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.