Not Yet RecruitingNot Applicable

Radiofrequency Ablation of Rammii Communicans Versus Annuloplasty in Discogenic Back Pain

90 participantsStarted 2026-01-30

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of Pain Intensity Changes

Timeframe: 2 weeks,1 month, 3 months, and 6 months.

Trial details

NCT IDNCT07360444

SponsorEsraa Fathy Radwan Abd Elzaher

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-30

Contact for this trial

Esraa Fathy Radwan, Msc

00201065603520 fathyesraa295@gmail.com

View on ClinicalTrials.gov More Discogenic Back Pain Patients trials