Low Back PainNCT06695481
Radiofrequency Treatments for Lumbar Facet Joint Pain Management
An observational study of Low Back Pain and Zygapophyseal Joint Arthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators compared the effectiveness of medial branch conventional radiofrequency application and combined radiofrequency application in patients with lumbar facet joint disease , focusing on pain scores. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Low Back Pain, Zygapophyseal Joint Arthritis
- What is being tested?
- Conventional RF and Combined RF
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 133 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Oct 2023
- Phase
- Observational
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are clinically diagnosed with lumbar facet joint pain after getting a pain reduction of over 50% following a selective diagnostic block (0.5 ml 2% lidocaine) performed on the facet joint medial branch block and after then RF (cobined or conventional) application under fluoroscopy.
Who may be able to join
- 40 - 90 years of age
- Patients with low back pain for more than three months and did not respond to conservative treatment
Who cannot join
- Patients who underwent facet joint medial branch RF treatment previously
- Patients had additional interventional pain treatment or lumbar surgery within one year of the procedure
- Patients had radicular and significant disc pathology, psychiatric diseases or mental problems, malignancies
- Patients of one year follow-up could not be assessed entirely in the system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Combined Versus Conventional Radiofrequency Thermocoagulation for Lumbar Facet Joint Pain Management: A Retrospective Study
In this study, investigators compared the effectiveness of medial branch conventional radiofrequency application and combined radiofrequency application in patients with lumbar facet joint disease , focusing on pain scores. The combined radiofrequency application, a sequence of pulsed radiofrequency and conventional radiofrequency , has been shown to be successful in treating neck pain and headache. These findings are of significant importance in the field of pain management and spinal disorders.
Read the detailed description
The treatment of chronic pain using pulsed radiofrequency (RF) has not shown any significant side effects. As a result, a combined approach of using both pulsed and conventional RF treatment in the same session has been assumed since the 2010s. This combined RF method is still widely used for pain management. The aim of this study is to compare the effectiveness of conventional RF with the combined RF method as a medial branch RF method for the management of lumbar facet joint pain.The study involved patients who had undergone medial branch denervation for lumbar facet joint pain and had medical records available. This study was conducted retrospectively by examining the study data. Patients with missing data were excluded from the study.
Patients underwent a fluoroscopy-guided selective medial branch nerve block using 2% lidocaine 0.5ml before treatment. After 30 minutes, they were asked if there was a 50% reduction in pain intensity.The conventional RF group consists of patients who received medial branch RF with a duration of 2 minutes, at 80̊ C temperature, and 7 Volts. In the combined RF group, treatment was initiated first with a conventional RF duration of 2 minutes at a temperature of 80̊ C at 7 Volts. Then, pulsed RF duration was applied for 6 minutes at a temperature of 42 C at 45 Volts, with a pulse frequency of 2 Hz and a width of 20 ms.After procedure In the outpatient clinic, experienced pain specialists recorded NRS (Numeric Rating Scale) and DN4 (Douleur Neuropathic 4 Questions) scores at the 6th and 12th-month follow-up appointments after the procedure.
- Conditions
- Low Back Pain, Zygapophyseal Joint Arthritis
- Being tested
- Conventional RF, Combined RF
- Keywords
- Pulsed Radiofrequency Treatment, Radiofrequency Ablation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RFProcedure or surgery
The conventional RF group consists of patients who received medial branch RF with a duration of 2 minutes, at 80̊ C temperature, and 7 Volts.
Combined RFProcedure or surgery
In the combined RF group, treatment was initiated first with a conventional RF duration of 2 minutes at a temperature of 80̊ C at 7 Volts. Then, pulsed RF duration was applied for 6 minutes at a temperature of 42 C at 45 Volts, with a pulse frequency of 2 Hz and a width of 20 ms.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | In this group, only patients who had facet joint medial branch conventional RF applied to the patients who benefited after diagnostic injection into the facet joint were selected. Receives: Procedure: Conventional RF | |
| Combined | This group was selected retrospectively from patients who benefited from diagnostic injection into the facet joint and who underwent pulsed rf in addition to facet joint medial branch conventional rf. Receives: Procedure: Combined RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Scale
Neuropathic Pain 4 Questions (DN4)
Measured: Scores of the patients ; before the procedure and 6 and 12 months after the procedure are shownThe 7 symptoms items are scored by interviewing the patient.The scores are added and a score of 4 or more out of ,10 point (severe pain ) .
Pain Rating Scale
Numeric Rating Scale
Measured: The NRS scores of the patients before the procedure and 6 and 12 months after the procedure .NRS in which individuals rate their pain on an ten-point numerical scale. Zero:''no pain at all' ten-point ''severe pain''
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Aug 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Yavuz, Hacettepe University
- Investigators
- Nalan Celebi, Professor, Study director, Hacettepe UniversityTuğçe Yavuz, M.D, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695481
- Sponsor's protocol ID
- 2023/13-08
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Malaithong W, Munjupong S. Combined Continuous Radiofrequency Ablation and Pulsed Neuromodulation to Treat Cervical Facet Joint Pain and Alleviate Postcervical Radiofrequency Side Effects. Anesth Pain Med. 2022 Dec 14;12(6):e129747. doi: 10.5812/aapm-129747. eCollection 2022 Dec.
PubMed 36938106Ding Y, Li H, Hong T, Zhu Y, Yao P, Zhou G. Combination of Pulsed Radiofrequency with Continuous Radiofrequency Thermocoagulation at Low Temperature Improves Efficacy and Safety in V2/V3 Primary Trigeminal Neuralgia. Pain Physician. 2018 Sep;21(5):E545-E553.
PubMed 30282402
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Combined Versus Conventional Radiofrequency Thermocoagulation for Lumbar Facet Joint Pain Management: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06695481
- Acronym / sponsor ID
- 2023/13-08
- Conditions
- Low Back Pain, Zygapophyseal Joint Arthritis
- Keywords
- Pulsed Radiofrequency Treatment, Radiofrequency Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 19 Nov 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.
In this study, investigators compared the effectiveness of medial branch conventional radiofrequency application and combined radiofrequency application in patients with lumbar facet joint disease , focusing on pain scores. The combined radiofrequency application, a sequence of pulsed radiofrequency and conventional radiofrequency , has been shown to be successful in treating neck pain and headache. These findings are of significant importance in the field of pain management and spinal disorders.
Detailed description
The treatment of chronic pain using pulsed radiofrequency (RF) has not shown any significant side effects. As a result, a combined approach of using both pulsed and conventional RF treatment in the same session has been assumed since the 2010s. This combined RF method is still widely used for pain management. The aim of this study is to compare the effectiveness of conventional RF with the combined RF method as a medial branch RF method for the management of lumbar facet joint pain.The study involved patients who had undergone medial branch denervation for lumbar facet joint pain and had medical records available. This study was conducted retrospectively by examining the study data. Patients with missing data were excluded from the study.
Patients underwent a fluoroscopy-guided selective medial branch nerve block using 2% lidocaine 0.5ml before treatment. After 30 minutes, they were asked if there was a 50% reduction in pain intensity.The conventional RF group consists of patients who received medial branch RF with a duration of 2 minutes, at 80̊ C temperature, and 7 Volts. In the combined RF group, treatment was initiated first with a conventional RF duration of 2 minutes at a temperature of 80̊ C at 7 Volts. Then, pulsed RF duration was applied for 6 minutes at a temperature of 42 C at 45 Volts, with a pulse frequency of 2 Hz and a width of 20 ms.After procedure In the outpatient clinic, experienced pain specialists recorded NRS (Numeric Rating Scale) and DN4 (Douleur Neuropathic 4 Questions) scores at the 6th and 12th-month follow-up appointments after the procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | – | Procedure: Conventional RFIn this group, only patients who had facet joint medial branch conventional RF applied to the patients who benefited after diagnostic injection into the facet joint were selected. |
| Combined | – | Procedure: Combined RFThis group was selected retrospectively from patients who benefited from diagnostic injection into the facet joint and who underwent pulsed rf in addition to facet joint medial branch conventional rf. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are clinically diagnosed with lumbar facet joint pain after getting a pain reduction of over 50% following a selective diagnostic block (0.5 ml 2% lidocaine) performed on the facet joint medial branch block and after then RF (cobined or conventional) application under fluoroscopy.
Key inclusion criteria (2 listed)
- 40 - 90 years of age
- Patients with low back pain for more than three months and did not respond to conservative treatment
Key exclusion criteria (4 listed)
- Patients who underwent facet joint medial branch RF treatment previously
- Patients had additional interventional pain treatment or lumbar surgery within one year of the procedure
- Patients had radicular and significant disc pathology, psychiatric diseases or mental problems, malignancies
- Patients of one year follow-up could not be assessed entirely in the system
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 |
|---|---|---|
| Conventional RFThe conventional RF group consists of patients who received medial branch RF with a duration of 2 minutes, at 80̊ C temperature, and 7 Volts. | Procedure or surgery | Conventional |
| Combined RFIn the combined RF group, treatment was initiated first with a conventional RF duration of 2 minutes at a temperature of 80̊ C at 7 Volts. Then, pulsed RF duration was applied for 6 minutes at a temperature of 42 C at 45 Volts, with a pulse frequency of 2 Hz and a width of 20 ms. | Procedure or surgery | Combined |
Primary outcome
Neuropathic Pain Scale
Time frame: Scores of the patients ; before the procedure and 6 and 12 months after the procedure are shownThe 7 symptoms items are scored by interviewing the patient.The scores are added and a score of 4 or more out of ,10 point (severe pain ) .
Neuropathic Pain 4 Questions (DN4)
Pain Rating Scale
Time frame: The NRS scores of the patients before the procedure and 6 and 12 months after the procedure .NRS in which individuals rate their pain on an ten-point numerical scale. Zero:''no pain at all' ten-point ''severe pain''
Numeric Rating Scale
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 19 Nov 2024.
- Results publication: PubMed 36938106Malaithong W, Munjupong S. Combined Continuous Radiofrequency Ablation and Pulsed Neuromodulation to Treat Cervical Facet Joint Pain and Alleviate Postcervical Radiofrequency Side Effects. Anesth Pain Med. 2022 Dec 14;12(6):e129747. doi: 10.5812/aapm-129747. eCollection 2022 Dec.
- Results publication: PubMed 30282402Ding Y, Li H, Hong T, Zhu Y, Yao P, Zhou G. Combination of Pulsed Radiofrequency with Continuous Radiofrequency Thermocoagulation at Low Temperature Improves Efficacy and Safety in V2/V3 Primary Trigeminal Neuralgia. Pain Physician. 2018 Sep;21(5):E545-E553.
- 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. This study is not recruiting at the moment.
Nalan Celebi, Professor study director
Hacettepe University
Tuğçe Yavuz, M.D study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Zygapophyseal Joint Arthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 19 Nov 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 Turkey (Türkiye). 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?
Neuropathic Pain Scale (time frame: Scores of the patients ; before the procedure and 6 and 12 months after the procedure are shownThe 7 symptoms items are scored by interviewing the patient.The scores are added and a score of 4 or more out of ,10 point (severe pain ) .). 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 NCT06695481, which also lists 2 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 19 Nov 2024.