Radiofrequency Ablation of Rammii Communicans Versus Annuloplasty in Discogenic Back Pain

N/ANot Yet RecruitingNCT07360444

Esraa Fathy Radwan Abd Elzaher90 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Discogenic Back Pain Patients

Interventions

radiofrequency ablation of Rammii CommunicansPROCEDURE

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, Anteroposterior (AP) image Square off vertebral endplates Turn the C-arm obliquely toward the ipsilateral side, approximately 30°, until the transverse process overlaps the lateral margin of the vertebral body (Fig. 5.2a-c). Entry point is just below the transverse process, in line with the lateral edge of the vertebral body, about 6-7 cm off midline, depending on body habitus Needle entry at lumbar level chosen Coaxial view until bony contact is made with the vertebral body Lateral v

Annuloplasty Radiofrequency AblationPROCEDURE

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 vertebral endplates Turn the C-arm obliquely toward the ipsilateral side, approximately (20-30°), until the SAP (superior articular process) of the lower vertebra in the middle of the vertebral body Needle entry at lumbar level chosen Coaxial view until bony contact is made with the SAP of the vertebral body Once touched, SAP "wiggle" laterally, constantly keeping the needle contacting the SAP with fluoroscopy control to the target location In the Lateral view, the tip of the needle is at th

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Assessment of Pain Intensity Changes

Change from baseline in the Numeric Rating Scale (NRS; 0-10) A Numeric Rating Scale (NRS) is a simple, widely used tool (often 0-10) for quantifying subjective experiences like pain or satisfaction, where 0 means none/worst and 10 means worst/best, allowing for easy tracking of changes, especially in healthcare for assessing pain intensity, treatment response, and function over time. It's used in research and clinical settings to get a numerical measure of abstract feelings, with anchors like "no pain" (0) and "worst imaginable pain" (10)

Time frame: 2 weeks,1 month, 3 months, and 6 months.