MedTrace Logo

Radiofrequency Ablation of Rammii Communicans Versus Annuloplasty in Discogenic Back Pain

NCT07360444 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-22

No results posted yet for this study

Summary

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.

Conditions

  • Discogenic Back Pain Patients

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, 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

Sponsors & Collaborators

  • Esraa Fathy Radwan Abd Elzaher

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2029-01-30
Completion
2029-01-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07360444 on ClinicalTrials.gov