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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Active Comparator | Rammii Communicans Radiofrequency Ablation |
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| group 2 | Active Comparator | Annuloplasty Radiofrequency Ablation |
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| group 3 | Active Comparator | both techniques |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiofrequency ablation of Rammii Communicans | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 weeks,1 month, 3 months, and 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
Patients who were 18 years or older
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esraa Fathy Radwan, Msc | Contact | 00201065603520 | fathyesraa295@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20825564 | Result | Kallewaard JW, Terheggen MA, Groen GJ, Sluijter ME, Derby R, Kapural L, Mekhail N, van Kleef M. 15. Discogenic low back pain. Pain Pract. 2010 Nov-Dec;10(6):560-79. doi: 10.1111/j.1533-2500.2010.00408.x. Epub 2010 Sep 6. | |
| 14668658 | Result | Oh WS, Shim JC. A randomized controlled trial of radiofrequency denervation of the ramus communicans nerve for chronic discogenic low back pain. Clin J Pain. 2004 Jan-Feb;20(1):55-60. doi: 10.1097/00002508-200401000-00011. |
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| Annuloplasty Radiofrequency Ablation | Procedure | 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 |
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