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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOndokuz Mayıs University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Younger then 18

Reluctance to participate in the study

Severe anatomic deformation in lumbar vertebral region

Presence or suspicion of pregnancy

Trial population

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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Lumbar facet joints medial branch nerve radiofrequency ablation

    Procedure/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 ablation

    Procedure/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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Group High1 intervention

Trial outcomes

Primary outcomes

1

Numerical Rating Scale (NRS)

Pain assessement tool

Time frame
One month

Secondary outcomes

1

Oswestry Disability Index (ODI)

A tool for assessment of the severity of low back pain

Time frame
one month

Other outcomes

Sponsors and contacts

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