Analgesic EfficacyNCT06684821
Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis
A study testing Racz catheter and Classic lumber fixation in people with Analgesic Efficacy and Epidural, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the analgesic efficacy of epidural neuroplasty using a Racz catheter during lumber fixation in situ for lumbosacral spondylolisthesis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesic Efficacy, Epidural, Neuroplasty
- What is being tested?
- Racz catheter and Classic lumber fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Nov 2024to 17 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- Patients suffering from spondylolisthesis grade 0, 1, 2 complaining of low back pain and/or sciatica.
Who cannot join
- Uncooperative patients.
- Patients in need of discectomy for lumber disc prolapse.
- Patients with severe canal stenosis and in need of spinal laminectomy.
- Contraindications to perform the proper technique e.g., coagulopathy and skin infection.
- Body mass index (BMI) ≥35 kg/m2.
- History of allergy to contrast medium.
- Previously operated traditional spine surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis: A Randomized Controlled Trial
This study aims to evaluate the analgesic efficacy of epidural neuroplasty using a Racz catheter during lumber fixation in situ for lumbosacral spondylolisthesis.
Read the detailed description
Lumbosacral spondylolisthesis, a common neurosurgical disorder, involves the anterior displacement of a vertebra in relation to the one below it. It often leads to back pain and neurologic symptoms.
Epidural lysis of adhesions is a procedure which treat chronic LBP in patients which didn't respond to medical treatments.The technique of Radiofrequency ablation (RFA) uses high-frequency current to produce tissue coagulation and heat. It involves the use of radio waves, applied through a percutaneous probe to generate heat and create a lesion in a spinal sensory nerve
- Conditions
- Analgesic Efficacy, Epidural, Neuroplasty, Racz Catheter, Lumbar Fixation, Lumbosacral Spondylolisthesis
- Being tested
- Racz catheter, Classic lumber fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Racz catheterProcedure or surgery
Patients will undergo epidural neuroplasty using Racz catheter during lumber fixation.
Classic lumber fixationProcedure or surgery
Patients will undergo classic lumber fixation.
| Study group | Role | What they receive |
|---|---|---|
| Racz catheter group | Experimental | Patients will undergo epidural neuroplasty using Racz catheter during lumber fixation. Receives: Procedure: Racz catheter |
| Control group | Active comparator | Patients will undergo classic lumber fixation. Receives: Procedure: Classic lumber fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Disability
Degree of Disability will be assessed using Oswestry Low Back Disability Questionnaire: This questionnaire has been designed to give us information as to how back pain has affected a patient's ability to manage everyday life. It consists of 10 questions for each question, there is a possible 5 points (0 for the first answer, 1 for the second answer, etc). Add up the total for the 10 questions and rate them on the scale (0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, 35-50 complete disability). It will be assisted pre-procedure as a baseline, after 1, 2, 4, 6 month post-procedure
Measured: 6 month post-procedure
Secondary outcomes (3)
Degree of pain
Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed pre-procedure as baseline, immediately post-procedure, 1, 2, 4, 6 month post-procedure
Measured: 6 month post-procedure
Degree of patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 6 month post-procedure
Incidence of complications
Incidence of complications that may occur during the technique such as (bending of the tip of the needle, shearing of the catheter, misplacement of the catheter, blocking of the catheter, blood aspiration and bleeding in the epidural space, hypotension, migration of the catheter, paresthesia, headache and infection) will be recorded.
Measured: 6 month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start14 Nov 2024
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesic EfficacyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684821
- Sponsor's protocol ID
- 36264PR903/10/24
- Status last verified
- Apr 2025
- First submitted
- 11 Nov 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Elhamid ASA, Elsharkawy MS, Shaheen MM, Hamama K, Nada A, Abdelraheem TM. Analgesic Efficacy of Epidural Neuroplasty via Racz Catheter During Lumbar Fixation In Situ for Lumbosacral Spondylolisthesis: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Jan 6;2026:1031307. doi: 10.1155/anrp/1031307. eCollection 2026.
PubMed 41503144
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06684821
- Acronym / sponsor ID
- 36264PR903/10/24
- Conditions
- Analgesic Efficacy, Epidural, Neuroplasty, Racz Catheter, Lumbar Fixation, Lumbosacral Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 12 Nov 2024 (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.
This study aims to evaluate the analgesic efficacy of epidural neuroplasty using a Racz catheter during lumber fixation in situ for lumbosacral spondylolisthesis.
Detailed description
Lumbosacral spondylolisthesis, a common neurosurgical disorder, involves the anterior displacement of a vertebra in relation to the one below it. It often leads to back pain and neurologic symptoms.
Epidural lysis of adhesions is a procedure which treat chronic LBP in patients which didn't respond to medical treatments.The technique of Radiofrequency ablation (RFA) uses high-frequency current to produce tissue coagulation and heat. It involves the use of radio waves, applied through a percutaneous probe to generate heat and create a lesion in a spinal sensory nerve
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Racz catheter group | Experimental | Procedure: Racz catheterPatients will undergo epidural neuroplasty using Racz catheter during lumber fixation. |
| Control group | Active comparator | Procedure: Classic lumber fixationPatients will undergo classic lumber fixation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18 to 65 years.
- Both sexes.
- Patients suffering from spondylolisthesis grade 0, 1, 2 complaining of low back pain and/or sciatica.
Key exclusion criteria (7 listed)
- Uncooperative patients.
- Patients in need of discectomy for lumber disc prolapse.
- Patients with severe canal stenosis and in need of spinal laminectomy.
- Contraindications to perform the proper technique e.g., coagulopathy and skin infection.
- Body mass index (BMI) ≥35 kg/m2.
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 |
|---|---|---|
| Racz catheterPatients will undergo epidural neuroplasty using Racz catheter during lumber fixation. | Procedure or surgery | Racz catheter group |
| Classic lumber fixationPatients will undergo classic lumber fixation. | Procedure or surgery | Control group |
Primary outcome
Degree of Disability
Time frame: 6 month post-procedure
Degree of Disability will be assessed using Oswestry Low Back Disability Questionnaire: This questionnaire has been designed to give us information as to how back pain has affected a patient's ability to manage everyday life. It consists of 10 questions for each question, there is a possible 5 points (0 for the first answer, 1 for the second answer, etc). Add up the total for the 10 questions and rate them on the scale (0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, 35-50 complete disability). It will be assisted pre-procedure as a baseline, after 1, 2, 4, 6 month post-procedure
3 secondary outcomes
Degree of pain
Time frame: 6 month post-procedure
Degree of patient satisfaction
Time frame: 6 month post-procedure
Incidence of complications
Time frame: 6 month post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 41503144Elhamid ASA, Elsharkawy MS, Shaheen MM, Hamama K, Nada A, Abdelraheem TM. Analgesic Efficacy of Epidural Neuroplasty via Racz Catheter During Lumbar Fixation In Situ for Lumbosacral Spondylolisthesis: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Jan 6;2026:1031307. doi: 10.1155/anrp/1031307. eCollection 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Racz catheter and Classic lumber fixation in people with Analgesic Efficacy and Epidural, run by Tanta University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Disability (time frame: 6 month post-procedure). 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 NCT06684821, which also lists 1 linked publication.
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 23 Apr 2025.