Radiofrequency Ablation of Rammii Communicans Versus Annuloplasty in Discogenic Back Pain

Esraa Fathy Radwan Abd Elzaher

Status: Not yet enrolling

Conditions: Discogenic Back Pain Patients

Treatments: Procedure: radiofrequency ablation of Rammii Communicans; Procedure: Annuloplasty Radiofrequency Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT07360444

rammii radiofrequency ablation

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

group 1

Active Comparator group

Description:

Rammii Communicans Radiofrequency Ablation

Treatment:

Procedure: radiofrequency ablation of Rammii Communicans

group 2

Active Comparator group

Description:

Annuloplasty Radiofrequency Ablation

Treatment:

Procedure: Annuloplasty Radiofrequency Ablation

group 3

Active Comparator group

Description:

both techniques

Treatment:

Procedure: Annuloplasty Radiofrequency Ablation

Procedure: radiofrequency ablation of Rammii Communicans