Discogenic Back Pain PatientsNCT07360444
Radiofrequency Ablation of Rammii Communicans Versus Annuloplasty in Discogenic Back Pain
A study testing radiofrequency ablation of Rammii Communicans and Annuloplasty Radiofrequency Ablation in people with Discogenic Back Pain Patients, run by Esraa Fathy Radwan Abd Elzaher.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Discogenic Back Pain Patients
- What is being tested?
- radiofrequency ablation of Rammii Communicans and Annuloplasty Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read more
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
- Being tested
- radiofrequency ablation of Rammii Communicans, Annuloplasty Radiofrequency Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablation of Rammii CommunicansProcedure or surgery
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
Annuloplasty Radiofrequency AblationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | Rammii Communicans Radiofrequency Ablation Receives: Procedure: radiofrequency ablation of Rammii Communicans |
| group 2 | Active comparator | Annuloplasty Radiofrequency Ablation Receives: Procedure: Annuloplasty Radiofrequency Ablation |
| group 3 | Active comparator | both techniques Receives: Procedure: radiofrequency ablation of Rammii Communicans; Procedure: Annuloplasty Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks,1 month, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Discogenic Back Pain PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esraa Fathy Radwan Abd Elzaher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esraa Fathy Radwan Abd Elzaher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360444
- Sponsor's protocol ID
- rammii radiofrequency ablation
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20825564Oh 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.
PubMed 14668658
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Radiofrequency Ablation of Rammii Communicans Versus Annuloplasty or Both Together in Discogenic Back Pain Patients Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07360444
- Acronym / sponsor ID
- rammii radiofrequency ablation
- Conditions
- Discogenic Back Pain Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Esraa Fathy Radwan Abd ElzaherUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: radiofrequency ablation of Rammii CommunicansRammii Communicans Radiofrequency Ablation |
| group 2 | Active comparator | Procedure: Annuloplasty Radiofrequency AblationAnnuloplasty Radiofrequency Ablation |
| group 3 | Active comparator | Procedure: radiofrequency ablation of Rammii Communicans, Procedure: Annuloplasty Radiofrequency Ablationboth techniques |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency ablation of Rammii CommunicansStandard 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 or surgery | group 1, group 3 |
| Annuloplasty Radiofrequency AblationStandard 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 | Procedure or surgery | group 2, group 3 |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Results publication: PubMed 20825564Kallewaard 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.
- Results publication: PubMed 14668658Oh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency ablation of Rammii Communicans and Annuloplasty Radiofrequency Ablation in people with Discogenic Back Pain Patients, run by Esraa Fathy Radwan Abd Elzaher.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Fathy Radwan, Msc (00201065603520, fathyesraa295@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pain Intensity Changes (time frame: 2 weeks,1 month, 3 months, and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07360444, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.