The Relation of the Anatomic Morphology of Lumbar Transverse Processes and the Success Rate of Facet Joint Radiofrequency Denervation

NCT07076810 | Not Yet Recruiting

• 1 other identifier: OMÜ KAEК 2025/252
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lower Back Pain Chronic

Keywords

lower back pain; radiofrequency; facet joint; transverse process

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS)

  Pain assessement tool

  One month

Secondary Outcomes (1)

• Oswestry Disability Index (ODI)

  one month

Study Arms (1)

Group High

Procedure: Lumbar facet joints medial branch nerve radiofrequency ablation

Interventions

Lumbar facet joints medial branch nerve radiofrequency ablation PROCEDURE

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.

Group High

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who have lumbar facet joint-originated lower back pain for longer than 6 months.

You may qualify if:

• Lumbar facet joint-originated lower back pain longer then 6 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Faculty of Medicine

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 6495013 BACKGROUND

• Konin 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.

  PMID: 20203111 BACKGROUND

• Guan 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.

  PMID: 30425005 BACKGROUND

• Erken 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.

  PMID: 12163729 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mustafa Kurçaloğlu, Assistant Professor

CONTACT

+905062983830; mkurcal@gmail.com

Aymen Warille, Professor

CONTACT

+905378978358; aymen.warille@omu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

TU (1)