Pulsed RadiofrequencyRadiofrequencyNCT06264297
High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial
A study testing Radiofrequency in people with Pulsed Radiofrequency and Lumbar Radiculopathy, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulsed Radiofrequency, Lumbar Radiculopathy
- What is being tested?
- Radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients over 18 years of age.
- Unilateral pain radiating to the lower extremity (with or without lumbar pain), which clinically corresponds to the path of the corresponding dermatomes.
- Correlation between clinical symptoms and lesion observed by magnetic resonance imaging (MRI).
- Radicular syndrome of three months or more of evolution.
- Normal or pathological electromyogram (EMG).
- Pain with neuropathic characteristics confirmed by the DN4 neuropathic pain questionnaire.
- Patients with a previous positive block diagnosis.
- Patients who have signed the informed consent document.
Who cannot join
- Patients under 18 years of age.
- Patients with non-radicular low back pain.
- MRI not consistent with the patient\'s symptoms.
- Patients with peripheral neuropathy of the lower extremities.
- Patients with a history or current diagnosis of serious mental disorder.
- Patients with moderate or severe cognitive impairment, or evidence of acute or subacute confusional syndrome.
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- Infection at the puncture site.
- Coagulation disorders.
- Pregnant patients.
- Patients who refuse to sign the informed consent document.
- Patients allergic to radiological contrast.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Maria Martinez Garcia, +34650528215, mariamartinezgarcia@gmail.com
mariamartinezgarcia@gmail.com
About this study
The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain.
- Conditions
- Pulsed Radiofrequency, Lumbar Radiculopathy
- Being tested
- Radiofrequency
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyProcedure or surgery
Pulsed radiofrequency (PRF) is a nonablative pain treatment that uses radiofrequency current in short high-voltage bursts, resulting in interruption of nociceptive afferent pathways. This study aims to show how the variation in radiofrequency voltage applied to the dorsal root ganglion (DRG) affects the treatment of neuropathic pain.
| Study group | Role | What they receive |
|---|---|---|
| GROUP I | Active comparator | RFP on the affected level or levels will be carried out during three cycles of 120 s, limited to a temperature of 42° and a voltage of 45V Receives: Procedure: Radiofrequency |
| GROUP II | Experimental | RFP on the affected level or levels will be carried out during three cycles of 120 s, limited to a temperature of 42° and a voltage of 65V Receives: Procedure: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE
this questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (4)
DN4 - QUESTIONNAIRE
DN4 - QUESTIONNAIRE To estimate the probability of neuropathic pain, please answer yes or no for each item of the following four questions.
Measured: From enrollment to the end of treatment at 6 months
Visual Numeric Scale
ranging from 0 to 10 was used to measure pain intensity
Measured: From enrollment to the end of treatment at 6 months
Categorical scale
uses adjectives, such as "mild," "moderate," "severe," and excruciating," to describe pain levels.
Measured: From enrollment to the end of treatment at 6 months
patient global impression of improvement (pgi-i) score
is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start20 Feb 2023
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pulsed RadiofrequencyStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Martinez, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264297
- Sponsor's protocol ID
- 01-22-270-111
- Acronym
- Radiofrequency
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Erdine S, Bilir A, Cosman ER, Cosman ER Jr. Ultrastructural changes in axons following exposure to pulsed radiofrequency fields. Pain Pract. 2009 Nov-Dec;9(6):407-17. doi: 10.1111/j.1533-2500.2009.00317.x. Epub 2009 Sep 15.
PubMed 19761513Ewertowska E, Mercadal B, Munoz V, Ivorra A, Trujillo M, Berjano E. Effect of applied voltage, duration and repetition frequency of RF pulses for pain relief on temperature spikes and electrical field: a computer modelling study. Int J Hyperthermia. 2018 Feb;34(1):112-121. doi: 10.1080/02656736.2017.1323122. Epub 2017 May 16.
PubMed 28540817Cosman ER Jr, Cosman ER Sr. Electric and thermal field effects in tissue around radiofrequency electrodes. Pain Med. 2005 Nov-Dec;6(6):405-24. doi: 10.1111/j.1526-4637.2005.00076.x.
PubMed 16336478Russo M, Santarelli D, Wright R, Gilligan C. A History of the Development of Radiofrequency Neurotomy. J Pain Res. 2021 Dec 24;14:3897-3907. doi: 10.2147/JPR.S334862. eCollection 2021.
PubMed 34992451Abejon D, Garcia-del-Valle S, Fuentes ML, Gomez-Arnau JI, Reig E, van Zundert J. Pulsed radiofrequency in lumbar radicular pain: clinical effects in various etiological groups. Pain Pract. 2007 Mar;7(1):21-6. doi: 10.1111/j.1533-2500.2007.00105.x.
PubMed 17305674Van Boxem K, Huntoon M, Van Zundert J, Patijn J, van Kleef M, Joosten EA. Pulsed radiofrequency: a review of the basic science as applied to the pathophysiology of radicular pain: a call for clinical translation. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):149-59. doi: 10.1097/AAP.0000000000000063.
PubMed 24553305Vigneri S, Sindaco G, La Grua M, Zanella M, Lo Bianco G, Paci V, Vinci FM, Sciacca C, Ravaioli L, Pari G. Electrocatheter-mediated High-voltage Pulsed Radiofrequency of the Dorsal Root Ganglion in the Treatment of Chronic Lumbosacral Neuropathic Pain: A Randomized Controlled Study. Clin J Pain. 2020 Jan;36(1):25-33. doi: 10.1097/AJP.0000000000000766.
PubMed 31577546Van Boxem K, van Bilsen J, de Meij N, Herrler A, Kessels F, Van Zundert J, van Kleef M. Pulsed radiofrequency treatment adjacent to the lumbar dorsal root ganglion for the management of lumbosacral radicular syndrome: a clinical audit. Pain Med. 2011 Sep;12(9):1322-30. doi: 10.1111/j.1526-4637.2011.01202.x. Epub 2011 Aug 3.
PubMed 21812907Karakose Caliskan D, Akesen S, Turker YG, Gurbet A. The effect of combined pulsed radiofrequency treatment to dorsal root ganglion with transforaminal epidural steroid injection on pain. Agri. 2021 Oct;33(4):223-231. doi: 10.14744/agri.2021.94824.
PubMed 34671961Vuka I, Marcius T, Dosenovic S, Ferhatovic Hamzic L, Vucic K, Sapunar D, Puljak L. Efficacy and Safety of Pulsed Radiofrequency as a Method of Dorsal Root Ganglia Stimulation in Patients with Neuropathic Pain: A Systematic Review. Pain Med. 2020 Dec 25;21(12):3320-3343. doi: 10.1093/pm/pnaa141.
PubMed 32488240De M, Mohan VK, Bhoi D, Talawar P, Kumar A, Garg B, Trikha A, Dehran M, Kashyap L, Shende DR. Transforaminal Epidural Injection of Local Anesthetic and Dorsal Root Ganglion Pulsed Radiofrequency Treatment in Lumbar Radicular Pain: A Randomized, Triple-Blind, Active-Control Trial. Pain Pract. 2020 Feb;20(2):154-167. doi: 10.1111/papr.12840. Epub 2019 Oct 21.
PubMed 31538405Napoli A, Alfieri G, Scipione R, Andrani F, Leonardi A, Catalano C. Pulsed radiofrequency for low-back pain and sciatica. Expert Rev Med Devices. 2020 Feb;17(2):83-86. doi: 10.1080/17434440.2020.1719828. Epub 2020 Jan 23. No abstract available.
PubMed 31973587
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06264297
- Acronym / sponsor ID
- Radiofrequency / 01-22-270-111
- Conditions
- Pulsed Radiofrequency, Lumbar Radiculopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Feb 2024 (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.
The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP I | Active comparator | Procedure: RadiofrequencyRFP on the affected level or levels will be carried out during three cycles of 120 s, limited to a temperature of 42° and a voltage of 45V |
| GROUP II | Experimental | Procedure: RadiofrequencyRFP on the affected level or levels will be carried out during three cycles of 120 s, limited to a temperature of 42° and a voltage of 65V |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients over 18 years of age.
- Unilateral pain radiating to the lower extremity (with or without lumbar pain), which clinically corresponds to the path of the corresponding dermatomes.
- Correlation between clinical symptoms and lesion observed by magnetic resonance imaging (MRI).
- Radicular syndrome of three months or more of evolution.
- Normal or pathological electromyogram (EMG).
Key exclusion criteria (11 listed)
- Patients under 18 years of age.
- Patients with non-radicular low back pain.
- MRI not consistent with the patient\'s symptoms.
- Patients with peripheral neuropathy of the lower extremities.
- Patients with a history or current diagnosis of serious mental disorder.
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 |
|---|---|---|
| RadiofrequencyPulsed radiofrequency (PRF) is a nonablative pain treatment that uses radiofrequency current in short high-voltage bursts, resulting in interruption of nociceptive afferent pathways. This study aims to show how the variation in radiofrequency voltage applied to the dorsal root ganglion (DRG) affects the treatment of neuropathic pain. | Procedure or surgery | GROUP I, GROUP II |
Primary outcome
OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE
Time frame: From enrollment to the end of treatment at 6 months
this questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life
4 secondary outcomes
DN4 - QUESTIONNAIRE
Time frame: From enrollment to the end of treatment at 6 months
Visual Numeric Scale
Time frame: From enrollment to the end of treatment at 6 months
Categorical scale
Time frame: From enrollment to the end of treatment at 6 months
patient global impression of improvement (pgi-i) score
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Background: PubMed 19761513Erdine S, Bilir A, Cosman ER, Cosman ER Jr. Ultrastructural changes in axons following exposure to pulsed radiofrequency fields. Pain Pract. 2009 Nov-Dec;9(6):407-17. doi: 10.1111/j.1533-2500.2009.00317.x. Epub 2009 Sep 15.
- Background: PubMed 28540817Ewertowska E, Mercadal B, Munoz V, Ivorra A, Trujillo M, Berjano E. Effect of applied voltage, duration and repetition frequency of RF pulses for pain relief on temperature spikes and electrical field: a computer modelling study. Int J Hyperthermia. 2018 Feb;34(1):112-121. doi: 10.1080/02656736.2017.1323122. Epub 2017 May 16.
- Background: PubMed 16336478Cosman ER Jr, Cosman ER Sr. Electric and thermal field effects in tissue around radiofrequency electrodes. Pain Med. 2005 Nov-Dec;6(6):405-24. doi: 10.1111/j.1526-4637.2005.00076.x.
- Background: PubMed 34992451Russo M, Santarelli D, Wright R, Gilligan C. A History of the Development of Radiofrequency Neurotomy. J Pain Res. 2021 Dec 24;14:3897-3907. doi: 10.2147/JPR.S334862. eCollection 2021.
- Background: PubMed 17305674Abejon D, Garcia-del-Valle S, Fuentes ML, Gomez-Arnau JI, Reig E, van Zundert J. Pulsed radiofrequency in lumbar radicular pain: clinical effects in various etiological groups. Pain Pract. 2007 Mar;7(1):21-6. doi: 10.1111/j.1533-2500.2007.00105.x.
- Background: PubMed 24553305Van Boxem K, Huntoon M, Van Zundert J, Patijn J, van Kleef M, Joosten EA. Pulsed radiofrequency: a review of the basic science as applied to the pathophysiology of radicular pain: a call for clinical translation. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):149-59. doi: 10.1097/AAP.0000000000000063.
- Background: PubMed 31577546Vigneri S, Sindaco G, La Grua M, Zanella M, Lo Bianco G, Paci V, Vinci FM, Sciacca C, Ravaioli L, Pari G. Electrocatheter-mediated High-voltage Pulsed Radiofrequency of the Dorsal Root Ganglion in the Treatment of Chronic Lumbosacral Neuropathic Pain: A Randomized Controlled Study. Clin J Pain. 2020 Jan;36(1):25-33. doi: 10.1097/AJP.0000000000000766.
- Background: PubMed 21812907Van Boxem K, van Bilsen J, de Meij N, Herrler A, Kessels F, Van Zundert J, van Kleef M. Pulsed radiofrequency treatment adjacent to the lumbar dorsal root ganglion for the management of lumbosacral radicular syndrome: a clinical audit. Pain Med. 2011 Sep;12(9):1322-30. doi: 10.1111/j.1526-4637.2011.01202.x. Epub 2011 Aug 3.
- Background: PubMed 34671961Karakose Caliskan D, Akesen S, Turker YG, Gurbet A. The effect of combined pulsed radiofrequency treatment to dorsal root ganglion with transforaminal epidural steroid injection on pain. Agri. 2021 Oct;33(4):223-231. doi: 10.14744/agri.2021.94824.
- Background: PubMed 32488240Vuka I, Marcius T, Dosenovic S, Ferhatovic Hamzic L, Vucic K, Sapunar D, Puljak L. Efficacy and Safety of Pulsed Radiofrequency as a Method of Dorsal Root Ganglia Stimulation in Patients with Neuropathic Pain: A Systematic Review. Pain Med. 2020 Dec 25;21(12):3320-3343. doi: 10.1093/pm/pnaa141.
- Background: PubMed 31538405De M, Mohan VK, Bhoi D, Talawar P, Kumar A, Garg B, Trikha A, Dehran M, Kashyap L, Shende DR. Transforaminal Epidural Injection of Local Anesthetic and Dorsal Root Ganglion Pulsed Radiofrequency Treatment in Lumbar Radicular Pain: A Randomized, Triple-Blind, Active-Control Trial. Pain Pract. 2020 Feb;20(2):154-167. doi: 10.1111/papr.12840. Epub 2019 Oct 21.
- Background: PubMed 31973587Napoli A, Alfieri G, Scipione R, Andrani F, Leonardi A, Catalano C. Pulsed radiofrequency for low-back pain and sciatica. Expert Rev Med Devices. 2020 Feb;17(2):83-86. doi: 10.1080/17434440.2020.1719828. Epub 2020 Jan 23. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency in people with Pulsed Radiofrequency and Lumbar Radiculopathy, run by Consorci Sanitari de Terrassa at 1 site in Spain.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Feb 2024. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Martinez (+34650528215, mariamartinezgarcia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE (time frame: From enrollment to the end of treatment at 6 months). 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 NCT06264297, which also lists 12 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 16 Feb 2024.