Lower Back Pain ChronicNCT07076810
The Relation of the Anatomic Morphology of Lumbar Transverse Processes and the Success Rate of Facet Joint Radiofrequency Denervation
An observational study of Lower Back Pain Chronic, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Adult patients who were planned for lumbar facet joint medial branch nerve Radiofrequency ablation under fluoroscopic guidance because of facet joint-originated chronic lower back pain will be included in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Back Pain Chronic
- What is being tested?
- Lumbar facet joints medial branch nerve radiofrequency ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Jun 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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
Study population: Adult patients who have lumbar facet joint-originated lower back pain for longer than 6 months.
Who may be able to join
- Lumbar facet joint-originated lower back pain longer then 6 months.
Who cannot join
- Younger then 18
- Reluctance to participate in the study
- Severe anatomic deformation in lumbar vertebral region
- Presence or suspicion of pregnancy
- Inability to answer the questions of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Faculty of Medicine
Samsun, Atakum, 55200
About this study
Official title: Morphology of Lumbar Transverse Processes and Relationship With the Success of Lumbar Medial Branch Radiofrequency Ablation in Facet Syndrome
Adult patients who were planned for lumbar facet joint medial branch nerve Radiofrequency ablation under fluoroscopic guidance because of facet joint-originated chronic lower back pain will be included in this study. Pain scores (Numerical Rating Scale and Oswestry Disability Index) will be recorded before and one month after the intervention. The morphology of the transverse processes and the facet joints (sizes and angles) will be evaluated using the computer tomography images that patients have in routine examination process. The possible relationship between the success rate of the procedure and the morphology of the transverse processes will be assessed by statistical analysis.
Read the detailed description
Our study will include patients who are examined at the Ondokuz Mayis University Algology Outpatient Clinic and diagnosed with chronic low back pain originating from the facet joints and deemed suitable for lumbar facet joint medial branch radiofrequency RF ablation (RFA) treatment. The study period will be between August 1, 2025, and June 30, 2026. Those who do not volunteer to participate in the study, those with significant anatomical deformities in the lumbar spine, those unable to answer the study questions, those with a history of lumbar vertebral surgery, and those who are or may be pregnant will be excluded.
Patients' gender, age, body mass index, and the duration of pain will be recorded. Patients' pain intensity will be assessed using the Numerical Rating Scale (NRS) and the Oswestry Disability Index (ODI). The NRS asks patients to rate their pain intensity between 0 and 10. 0 represents no pain, and 10 represents the highest pain they can imagine. Patients' NRS scores and ODI scores at rest and during activity will be recorded before and 1 month after the RFA procedure. A 40% or greater reduction in ODI score will be defined as "significant benefit from the procedure." The angles of the superior articular and transverse processes at the bilateral L1/2, L2/3, L3/4, L4/5, and L5/S1 levels, as well as the angles of the facet joint in the axial plane, will be calculated from Lumbar Spine Computed Tomography images taken during the diagnosis and treatment processes. No additional imaging will be required for this study; the data will be obtained from the patients' previously obtained lumbar spine CT images.
Patients will be divided into two groups for each level: "greater angle" and "lesser angle," based on the angles specified above. Post-procedure pain scores and the rate of significant benefit from the procedure will be compared. Patients will be evaluated one month after the procedure for pain scores and Oswestry Disability Index. Furthermore, a correlation will be investigated between the reduction in pain scores at each level and the specified angles. Statistical analyses of the study will be conducted using Statistical Package for Social Sciences (SPSS) version 26. Data obtained by counting will be expressed as numbers and percentages, and data obtained by measurement will be expressed as mean ± standard deviation. The Student t-test will be used for parameters showing normal distribution in comparisons of descriptive statistical methods and quantitative data, and the Mann-Whitney U test will be used for parameters not showing normal distribution. The chi-square test will be used for comparisons of qualitative data.
The relationship between changes in pain scores and the anatomical angles evaluated in the study will be assessed using the Pearson Correlation Test. A P value of less than 0.05 will be considered statistically significant.
This cross-sectional, observational study will not interfere with the patients' routine treatment protocols.
Sample Size and Statistical Methods: Statistical analyses of the study will be conducted using SPSS (Statistical Package for Social Sciences) version 26. Data obtained by counting will be expressed as numbers and percentages, and data obtained by measurement will be expressed as mean ± standard deviation. The Student t-test will be used for normally distributed parameters when comparing descriptive statistical methods and quantitative data, and the Mann-Whitney U test will be used for non-normally distributed parameters. The chi-square test will be used for comparisons of qualitative data. The relationship between changes in pain scores and the anatomical angles evaluated in the study will be assessed using the Pearson Correlation Test. A P value of less than 0.05 will be considered statistically significant.
- Conditions
- Lower Back Pain Chronic
- Being tested
- Lumbar facet joints medial branch nerve radiofrequency ablation
- Keywords
- lower back pain, radiofrequency, facet joint, transverse process
- 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.
Lumbar facet joints medial branch nerve radiofrequency ablationProcedure or surgery
Patients will be positioned prone on the operation table. Intravenous access is opened. Monitorization for vital signs is performed. Light sedation with midazolam is performed. Under fluoroscopic guidance, medial branch nerve of each lumbar facet joint is found by searching the specific response to the stimulations of the radiofrequency needle. When the tip of the radiofrequency needle is close enough to the corresponding medial branch nerve, ablation with 80 degrees Celsius for 90 seconds is performed. Average 6-10 nerves are ablated in each procedure and the average duration of the procedure is 20-60 minutes.
Lumbar facet joints medial branch nerve radiofrequency ablationProcedure or surgery
Patients are positioned prone on the operation table. Intravenous access is opened and monitorization of vital signs is applied. Skin is cleaned by povidone iodine solution. Light sedation is applied by midazolam. Lumbar vertebral region is seen under C-arm fluoroscopic view. Medial branch nerve of the lumbar facet joints is searched by 22 G width, 10-cm length radiofrequency needles. When the needle tip is close enough to the nerve, an 80 Celsius, 90-second radiofrequency ablation is applied. In each procedure, average 5-10 nerves is ablated and the duration of the procedure is 20-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group High | Not described Receives: Procedure: Lumbar facet joints medial branch nerve radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Pain assessement tool
Measured: One month
Secondary outcomes (1)
Oswestry Disability Index (ODI)
A tool for assessment of the severity of low back pain
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lower Back Pain ChronicStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kurçaloğlu, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076810
- Sponsor's protocol ID
- OMÜ KAEК 2025/252
- Status last verified
- Aug 2025
- First submitted
- 12 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The authors of this study may share the participant data when there is a reasonable request.
Publications
Castellvi AE, Goldstein LA, Chan DP. Lumbosacral transitional vertebrae and their relationship with lumbar extradural defects. Spine (Phila Pa 1976). 1984 Jul-Aug;9(5):493-5. doi: 10.1097/00007632-198407000-00014.
PubMed 6495013Konin GP, Walz DM. Lumbosacral transitional vertebrae: classification, imaging findings, and clinical relevance. AJNR Am J Neuroradiol. 2010 Nov;31(10):1778-86. doi: 10.3174/ajnr.A2036. Epub 2010 Mar 4.
PubMed 20203111Guan W, Yu W, Lin Q, Zhang Z, Du G, Tian J, Xu Y, Hsieh E. Lumbar Vertebrae Morphological Analysis and an Additional Approach for Vertebrae Identification in Lumbar Spine DXA Images. J Clin Densitom. 2020 Jul-Sep;23(3):395-402. doi: 10.1016/j.jocd.2018.09.004. Epub 2018 Sep 15.
PubMed 30425005Erken E, Ozer HT, Gulek B, Durgun B. The association between cervical rib and sacralization. Spine (Phila Pa 1976). 2002 Aug 1;27(15):1659-64. doi: 10.1097/00007632-200208010-00013.
PubMed 12163729
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphology of Lumbar Transverse Processes and Relationship With the Success of Lumbar Medial Branch Radiofrequency Ablation in Facet Syndrome
- ClinicalTrials.gov ID
- NCT07076810
- Acronym / sponsor ID
- OMÜ KAEК 2025/252
- Conditions
- Lower Back Pain Chronic
- Keywords
- lower back pain, radiofrequency, facet joint, transverse process
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Jul 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.
Adult patients who were planned for lumbar facet joint medial branch nerve Radiofrequency ablation under fluoroscopic guidance because of facet joint-originated chronic lower back pain will be included in this study. Pain scores (Numerical Rating Scale and Oswestry Disability Index) will be recorded before and one month after the intervention. The morphology of the transverse processes and the facet joints (sizes and angles) will be evaluated using the computer tomography images that patients have in routine examination process. The possible relationship between the success rate of the procedure and the morphology of the transverse processes will be assessed by statistical analysis.
Detailed description
Our study will include patients who are examined at the Ondokuz Mayis University Algology Outpatient Clinic and diagnosed with chronic low back pain originating from the facet joints and deemed suitable for lumbar facet joint medial branch radiofrequency RF ablation (RFA) treatment. The study period will be between August 1, 2025, and June 30, 2026. Those who do not volunteer to participate in the study, those with significant anatomical deformities in the lumbar spine, those unable to answer the study questions, those with a history of lumbar vertebral surgery, and those who are or may be pregnant will be excluded.
Patients' gender, age, body mass index, and the duration of pain will be recorded. Patients' pain intensity will be assessed using the Numerical Rating Scale (NRS) and the Oswestry Disability Index (ODI). The NRS asks patients to rate their pain intensity between 0 and 10. 0 represents no pain, and 10 represents the highest pain they can imagine. Patients' NRS scores and ODI scores at rest and during activity will be recorded before and 1 month after the RFA procedure. A 40% or greater reduction in ODI score will be defined as "significant benefit from the procedure." The angles of the superior articular and transverse processes at the bilateral L1/2, L2/3, L3/4, L4/5, and L5/S1 levels, as well as the angles of the facet joint in the axial plane, will be calculated from Lumbar Spine Computed Tomography images taken during the diagnosis and treatment processes. No additional imaging will be required for this study; the data will be obtained from the patients' previously obtained lumbar spine CT images.
Patients will be divided into two groups for each level: "greater angle" and "lesser angle," based on the angles specified above. Post-procedure pain scores and the rate of significant benefit from the procedure will be compared. Patients will be evaluated one month after the procedure for pain scores and Oswestry Disability Index. Furthermore, a correlation will be investigated between the reduction in pain scores at each level and the specified angles. Statistical analyses of the study will be conducted using Statistical Package for Social Sciences (SPSS) version 26. Data obtained by counting will be expressed as numbers and percentages, and data obtained by measurement will be expressed as mean ± standard deviation. The Student t-test will be used for parameters showing normal distribution in comparisons of descriptive statistical methods and quantitative data, and the Mann-Whitney U test will be used for parameters not showing normal distribution. The chi-square test will be used for comparisons of qualitative data.
The relationship between changes in pain scores and the anatomical angles evaluated in the study will be assessed using the Pearson Correlation Test. A P value of less than 0.05 will be considered statistically significant.
This cross-sectional, observational study will not interfere with the patients' routine treatment protocols.
Sample Size and Statistical Methods: Statistical analyses of the study will be conducted using SPSS (Statistical Package for Social Sciences) version 26. Data obtained by counting will be expressed as numbers and percentages, and data obtained by measurement will be expressed as mean ± standard deviation. The Student t-test will be used for normally distributed parameters when comparing descriptive statistical methods and quantitative data, and the Mann-Whitney U test will be used for non-normally distributed parameters. The chi-square test will be used for comparisons of qualitative data. The relationship between changes in pain scores and the anatomical angles evaluated in the study will be assessed using the Pearson Correlation Test. A P value of less than 0.05 will be considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group High | – | Procedure: Lumbar facet joints medial branch nerve radiofrequency ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have lumbar facet joint-originated lower back pain for longer than 6 months.
Key inclusion criteria (1 listed)
- Lumbar facet joint-originated lower back pain longer then 6 months.
Key exclusion criteria (5 listed)
- Younger then 18
- Reluctance to participate in the study
- Severe anatomic deformation in lumbar vertebral region
- Presence or suspicion of pregnancy
- Inability to answer the questions of the study
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 |
|---|---|---|
| Lumbar facet joints medial branch nerve radiofrequency ablationPatients will be positioned prone on the operation table. Intravenous access is opened. Monitorization for vital signs is performed. Light sedation with midazolam is performed. Under fluoroscopic guidance, medial branch nerve of each lumbar facet joint is found by searching the specific response to the stimulations of the radiofrequency needle. When the tip of the radiofrequency needle is close enough to the corresponding medial branch nerve, ablation with 80 degrees Celsius for 90 seconds is performed. Average 6-10 nerves are ablated in each procedure and the average duration of the procedure is 20-60 minutes. | Procedure or surgery | Group High |
| Lumbar facet joints medial branch nerve radiofrequency ablationPatients are positioned prone on the operation table. Intravenous access is opened and monitorization of vital signs is applied. Skin is cleaned by povidone iodine solution. Light sedation is applied by midazolam. Lumbar vertebral region is seen under C-arm fluoroscopic view. Medial branch nerve of the lumbar facet joints is searched by 22 G width, 10-cm length radiofrequency needles. When the needle tip is close enough to the nerve, an 80 Celsius, 90-second radiofrequency ablation is applied. In each procedure, average 5-10 nerves is ablated and the duration of the procedure is 20-60 minutes. | Procedure or surgery | Group High |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: One month
Pain assessement tool
1 secondary outcome
Oswestry Disability Index (ODI)
Time frame: one month
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 19 Aug 2025.
- Results publication: PubMed 6495013Castellvi AE, Goldstein LA, Chan DP. Lumbosacral transitional vertebrae and their relationship with lumbar extradural defects. Spine (Phila Pa 1976). 1984 Jul-Aug;9(5):493-5. doi: 10.1097/00007632-198407000-00014.
- Results publication: PubMed 20203111Konin GP, Walz DM. Lumbosacral transitional vertebrae: classification, imaging findings, and clinical relevance. AJNR Am J Neuroradiol. 2010 Nov;31(10):1778-86. doi: 10.3174/ajnr.A2036. Epub 2010 Mar 4.
- Results publication: PubMed 30425005Guan W, Yu W, Lin Q, Zhang Z, Du G, Tian J, Xu Y, Hsieh E. Lumbar Vertebrae Morphological Analysis and an Additional Approach for Vertebrae Identification in Lumbar Spine DXA Images. J Clin Densitom. 2020 Jul-Sep;23(3):395-402. doi: 10.1016/j.jocd.2018.09.004. Epub 2018 Sep 15.
- Results publication: PubMed 12163729Erken E, Ozer HT, Gulek B, Durgun B. The association between cervical rib and sacralization. Spine (Phila Pa 1976). 2002 Aug 1;27(15):1659-64. doi: 10.1097/00007632-200208010-00013.
- Individual participant dataSharing planned: Undecided. The authors of this study may share the participant data when there is a reasonable request.
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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?
An observational study of Lower Back Pain Chronic, run by Ondokuz Mayıs 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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Aug 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 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?
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 Mustafa Kurçaloğlu, Assistant Professor (+905062983830, mkurcal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: One month). 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 NCT07076810, which also lists 4 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 Aug 2025.