Radiofrequency Ablation of Rammii Communicans Versus Annuloplasty in Discogenic Back Pain

January 16, 2026 updated by: Esraa Fathy Radwan Abd Elzaher

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1
Rammii Communicans Radiofrequency Ablation
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, 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
Active Comparator: group 2
Annuloplasty Radiofrequency Ablation
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 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
Active Comparator: group 3
both techniques
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, 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

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Pain Intensity Changes
Time Frame: 2 weeks,1 month, 3 months, and 6 months.
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)
2 weeks,1 month, 3 months, and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esraa Fathy Radwan Abd Elzaher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

January 30, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • rammii radiofrequency ablation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Discogenic Back Pain Patients

Clinical Trials on radiofrequency ablation of Rammii Communicans

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe