Radiofrequency Ablation of Rammii Communicans Versus Annuloplasty in Discogenic Back Pain

Official title

Safety and Efficacy of Radiofrequency Ablation of Rammii Communicans Versus Annuloplasty or Both Together in Discogenic Back Pain Patients Double-Blinded Randomized Controlled Trial

Overview

Aim of the study Comparing the safety, efficacy, pain reduction, and functional disability between Ramii communicans radiofrequency versus Annuloplasty versus combined both techniques in patients with discogenic low back pain Patient and methods • Study design: Prospective, randomized, double-blinded control clinical trial study. • Study suite: The study will be conducted in the pain management unit at the Department of Anesthesia and Pain Management, Assiut University Hospital, after approval of the local ethical committee. • Time of study: from January 2026 till the recruitment of all patients. The PICOT algorithm is preliminarily pointed out: * P (Population): patients complaining of Discogenic back pain with failed conservative treatment * I (Intervention) Patients scheduled for Rammii Communicans Radiofrequency Ablation * C (Comparison): patients scheduled for Annuloplasty Radiofrequency Ablation * O (Outcomes): Assess safety, Efficacy, pain reduction (assessed by Numeric Rating Scale), functional disability (assessed by Oswestry Disability Index), and Depression score (SF-36) between the two groups * T (Timing): 2weeks,1 month,3 months, and 6 months of follow-up.

Interventions

• Procedure radiofrequency ablation of Rammii Communicans
  Standard ASA monitoring, Fluoroscopy Sterile prep and drape Apply local anesthesia to the skin before any needle larger than 25G The coaxial view is always used to advance the needle CPR equipment and medications available 18-20G, 3.5 inch (90 mm) - 6 inch (150 mm), 5-10 mm active tip, blunt or sharp, curved radiofrequency cannula for radiofrequency ablation (RFA) Nonionic contrast Local anesthetic: 1-2 ml 1% lidocaine or 0.5% bupivacaine Fluoroscopy Technique, Target Localization Patient prone
• Procedure Annuloplasty Radiofrequency Ablation
  Standard ASA monitoring, Fluoroscopy Sterile prep and drape Apply local anesthesia to the skin before any needle larger than 25G The coaxial view is always used to advance the needle CPR equipment and medications available 18-20G, 3.5 inch (90 mm) - 6 inch (150 mm), 5-10 mm active tip, blunt or sharp, curved radiofrequency cannula for radiofrequency ablation (RFA) Nonionic contrast Local anesthetic: 1-2 ml 1% lidocaine or 0.5% bupivacaine Patient prone, Anteroposterior (AP) image Square off the

Primary outcome measures

• Assessment of Pain Intensity Changes [Time frame: 2 weeks,1 month, 3 months, and 6 months.]

Eligibility criteria

Inclusion criteria

• Patients who were 18 years or older
• Chronic LBP persisted for more than three months
• Failed medical treatment
• Axial LBP with or without leg radicular pain experienced pain exacerbation by sitting (intolerance to sitting), bending forward, coughing or sneezing, and partially relieved with lateral recumbent position, standing, or walking.
• Patients with a Numeric Rating Scale of pain severity of five points or higher, specifically to the daily LBP, were included in the study.
• The examination criteria for the study included tenderness on deep pressure of the spine process at the level of the degenerated disc and no neurological motor deficits.
• The magnetic resonance imaging (MRI) criteria required images to show clear evidence of degenerative disc disease in one or two-disc levels that include a high intensity zone (HIZ) in the posterior annulus and dark disc with or without loss of height

Exclusion criteria

• Encompassed patients with clinical evidence of progressive motor neurological deficits,
• MRI evidence of intervertebral disc herniation measuring 4 mm or more, sequestration, extrusion, disc space collapse, or spondylolisthesis at the symptomatic level.
• Patients with moderate to-severe central spinal canal or foraminal stenosis,
• Previous lumbar surgery at the same treatment level,
• Spinal fractures, deformities
• Infections or tumors
• Patients with psychotic illnesses, uncontrolled diabetes, advanced hepatic conditions, current pregnancy, recent delivery (within three months of consent), intent to become pregnant during the study period, and local sepsis or skin inflammation in the back region.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Kallewaard JW, Terheggen MA, Groen GJ, Sluijter ME, Derby R, Kapural L, Mekhail N, van Kleef M. 15. Discogenic low back pain. Pain Pract. 2010 Nov-Dec;10(6):560-79. doi: 10.1111/j.1533-2500.2010.00408.x. Epub 2010 Sep 6. PMID 20825564
• Oh WS, Shim JC. A randomized controlled trial of radiofrequency denervation of the ramus communicans nerve for chronic discogenic low back pain. Clin J Pain. 2004 Jan-Feb;20(1):55-60. doi: 10.1097/00002508-200401000-00011. PMID 14668658

Identifiers

NCT: NCT07360444 · rammii radiofrequency ablation

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗