Investigation the Role of BDNF and S100B Serum Level as a Predictive of Outcome of Pulsed Radiofrequency in Treatment Lumbar Disc Prolapse PatientsNCT05193461
The Potential Role of SI00B and Brain Derived Neurotrophic Factor in Predicting Outcome From Using Pulsed Radiofrequency in Treatment of Patients With Lumbar Disc Prolapsed
A study testing Pulsed mood radiofrequency on dorsal root ganglion in people with Investigation the Role of BDNF and S100B Serum Level as a Predictive of Outcome of Pulsed Radiofrequency in Treatment Lumbar Disc Prolapse Patients, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Chronic lumbar radicular (CLR) pain is a term used to describe neuropathic pain symptoms in the distribution of a particular lumbar nerve root due to disc protrusion, spinal stenosis, facet hypertrophy, or fibrosis after previous surgery. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Investigation the Role of BDNF and S100B Serum Level as a Predictive of Outcome of Pulsed Radiofrequency in Treatment Lumbar Disc Prolapse Patients
- What is being tested?
- Pulsed mood radiofrequency on dorsal root ganglion
- 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
- 1 Jan 2022to 1 Sep 2022
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as having symptomatic lumbar disc prolapse based on the following:
- Clinical evidence of disc pulge in the form of disc related radicular pain of >3 months duration with failed conservative treatment (i.e. physical therapy and multiple medications) and unwillingness to pursue surgical option.
- Radiological demonstration of posterolateral lumbar disc pulge by MRI or CT lumbosacral
- Age range is between 30-80 years
Who cannot join
- The following patients will be excluded from the study:
- Patients with spinal deformities
- Patients with a previous history of spinal trauma
- Patients with radiological evidence of any inflammatory or neoplastic lesion affecting the spinal cord or vertebral column
- Patients with severe lumbar disc herniation causing lower limb weakness or sphincteric troubles
- Patients with contraindications to interventions (coagulopathy or sepsis)
- Patients with contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body).
- Pregnant
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Wael Fathy Hassan
Banī Suwayf, 62511
Wael Fathy, Lecturer, 01006527133, drwaelfathy@yahoo.com
About this study
Chronic lumbar radicular (CLR) pain is a term used to describe neuropathic pain symptoms in the distribution of a particular lumbar nerve root due to disc protrusion, spinal stenosis, facet hypertrophy, or fibrosis after previous surgery. The pathophysiology of CLR pain involves mechanical, inflammatory, and immunologic factors that affect the function of the dorsal root ganglion (DRG).1Treatment methods include oral pain medications, physical therapy, epidural steroid injection (ESI) and surgery. 2,3.
Pulsed radiofrequency (PRF) was developed as a modification of the well-known radiofrequency ablation treatment. In conventional radiofrequency ablation, a high frequency alternating current is used to produce coagulative necrosis of the target nerve tissue without any selectivity for nociceptive fibers. However, in PRF, a current in short (20 msec) high voltage bursts is followed by silent phases (480 msec) which allow for heat dissemination, keeping the target tissue controlled below 42°C. 4,5 The mechanisms via which PRF causes analgesia are still not clearly understood, but laboratory experiments have highlighted some possible ways in which it might act, including its effects on neuropathic pain. Clinical use of PRF has been expanding, despite there being limited evidence of clinical efficacy in the form of randomized controlled trials (RCTs). 6 There have been few RCTs using PRF-DRG for radicular pain. Van Zundert et al performed an RCT in subjects with cervical radicular pain.7 Simopoulos et al did a pilot study on lumbar radicular pain, but the methodology included application of conventional radiofrequency over PRF in the study group and was not an efficacy trial. As such, the efficacy of PRF-DRG in CLR has never been determined. 8
Neuroplasticity or neuronal plasticity refers to the ability of the nervous system to do neuronal remodeling, formation of novel synapses and birth of new neurons. Neuronal plasticity is intimately linked to cellular responsiveness and may therefore be considered an index of the neuronal capability to restore its function. Failure of such mechanisms might enhance the susceptibility to neuronal injury.9 Neurotrophic factors (NTFs), and in particular the neurotrophin family, play an important role. In fact, besides their classical role in supporting neuronal survival, NTFs finely modulate all the crucial steps of network construction, from neuronal migration to experience-dependent refinement of local connections. It is now well established that NTFs are important mediators of neuronal plasticity also in adulthood where they modulate axonal and dendritic growth and remodeling, membrane receptor trafficking, neurotransmitter release, synapse formation and function.10 The neurotrophin brain-derived neurotrophic factor (BDNF) has emerged as crucial mediator of neuronal plasticity, suggesting that it might indeed bridge experience with enduring change in neuronal function.11BDNF acts on certain neurons of the central nervous system and the peripheral nervous system, helping to support survival of existing neurons, and encouraging growth and differentiation of new neurons and synapses.12,13 S100B belongs to the family ofcalcium binding proteins, is expressed mainly by astrocytesand is found both intra- and extracellularly in brain tissue. It was also reported that mature myelinating and non-myelinating Schwann cells of peripheral nerves strongly display S100 protein immunoreactivity (Stefansson et al., 1982; Sugimura et al., 1989; Vega et al., 1996).14 S100B can spill from injured cells and enter the extracellular space or bloodstream. Serum levels of S100B increase in patients with neuronal damage. Over the last decade, S100B has emerged as a candidate peripheral biomarker of neuronal injury. Elevated S100B levels accurately reflect the presence ofneurodegenerayion. Its potential clinical use in the therapeutic decisions is substantiated by a vast body of literature. Thus, the major advantage of using S100B is that its elevatio in serum provides a sensitive measure for determining neuronal injury at the molecular level before gross changes level.15
Read the detailed description
METHODS:
All patientswill be subjected to the following:
- Clinical assessment:
- Detailed history taking regarding: duration of pain, the presence of discogenic pain, radicular pain, responseto medical treatment, or previous interventional pain management
- Neurological examination: motor and sensory examination
- Assessment of the severity of the neurological symptoms before, 2 week, 1, 3 and 6 months after the interventional procedure by a physician who will be blinded to the patient's condition and the type of intervention. Modified Oswestry Back Disability Score (MODI): It consisted of low back pain disability index questionnaire about pain intensity, personal care, lifting, standing, walking, sitting, sleeping, social life, travelling and employment/homemaking. Thus, total 10 points; each had score range of 0-5. Hence, total score had range of 0-50. A high MODI score indicates a more severe functional disability related to the pain. Numeric Rating Scale (NRS-11): It is a scale for assessment of intensity of pain. It ranged from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.
- Assessment of patient's satisfaction about the intervention,2 week, 1, 3, and 6months after the interventional procedure by a physician who will be blinded to the patient's condition and the type of intervention.
The Short Assessment of Patient Satisfaction (SAPS): It consists of seven items assessing the core domains of patient satisfaction which include treatment satisfaction, explanation of treatment results, clinician care, participation in medical decision making, respect by the clinician, time with the clinician, and satisfaction with hospital/clinic care. Responses scales are 5-point scales. SAPS scores can be interpreted as follows: 0 to 10 = very dissatisfied, 11 to 18 = dissatisfied, 19 to 26 = satisfied, 27 to 28 = very satisfied.
- Radiological assessment:
Magnetic Resonance imaging (MRI):
Magnetic Resonance imaging of the lumbosacral spine will be performed for all patients included in the study.
The following protocols will be used:
- T1- weighted images (axial, sagittal).
- T2- weighted images (axial, coronal).
- Fluid attenuated inversion recovery (FLAIR) sequence. 3) Pulsed radio frequency (PRF): PRF of the dorsal root ganglion (DRG) will be performed to all participants in this study. The procedures will beperformed in the operating room under fluoroscopic guidance following radiation safety standards. The dorsal root ganglion of lumbosacral roots will be targeted. The patients will be positioned prone .Lidocaine 1% will be infiltrated at the skin entry site. A 10 cm, 22-gauge radiofrequency needle with a 5 mm curved active tip will be used. A radiculogram will be done to confirm appropriate placement and DRG will be stimulated for confirmation of the appropriate nerve root involved. Proximity of the needle to the DRG will be determined by appropriate sensory stimulation with 50 Hz (0.4-0.6 V), and motor stimulation at 2 Hz will be used to determine a threshold 1.5-2.0 times greater than the sensory threshold to avoid placement near the anterior nerve root. A pulsed lesion will be generated by applying 45 V to the DRG for 6 minutes at 42°C.
- Laboratory assessment
- Assessment of Brain Derived Neurotrophic Factor (BDNF) serum level:
Venous blood samples will be taken from all included patients before the interventional procedure and kept 30 minutes for clotting then centrifuged at 2,000-3,000 rpm for 20 minutes. Then, serum will be separated and kept under -80 c. The BDNF levels will be assessed using commercial sandwich-ELISA kits. The Microelisastripplatewill be pre-coated with an antibody specific to BDNF. Samples will be added to the appropriate Microelisastripplate wells and comoned to specific antibody. Then a Horseradish Peroxidase (HRP) conjugated antibody specific for BDNF will be added to each 'Microelisastripplate well and incubated. Free components will be washed away. The TMB substrate solution will be added to each well. Only those wells that contain BDNF and HRP conjugated BDNF antibody will appear blue and then turn to yellow after the addition of the stop solution. The optical density (OD) will be measured spectrophotometrically at a wavelength of 450 nm.
- Assessment of S100B serum level:
All participants will undergo quantitative assessment of serum S100B before the interventional procedure by applying a sandwich enzyme- linked immunoabsorbent assay technique (ELISA). Assays will be performed at the clinical and chemical pathology department, Beni-suef university hospital on an automated ELISA platform. Five mL of whole blood will be drawn from all included patients and put into a sterile plain tube. The blood samples will be centrifuged for twenty minutes at a speed 2000-3000 r.p.m. The supernatant serum will be collected and stored at -20 C till the time of analysis. Standard of S100B will be supplied as 120 microlitre containing 4000ng/L of S100B diluted by standard diluents to generate dilution range from 0 to 2000ng/L. Fifty mL of standard will be added to wells, they will be incubated for one hour at room temperature. The wells will be washed three times with washing solution (phosphate buffered saline, PH is from 7.0 to 7.2). 100 mL of conjugate will be added per each well. Each well will be washed again by washing solution five times. Fifty mL of substrate A (S100B horseradish peroxidase (HRP) conjugate) will be added to each well followed by addition of Fifty mL of substrate B (substrate for HRP enzyme containing small amount of 3,3,5,5 tetramethylbenzidine) then the wells will be covered and left at room temperature for ten minutes. Finally, fifty mL of stop solution (sulphuric acid) will be added to each well. Optical density will be read at 450 nm. The standard curve will be constructed using statistical software.
- Being tested
- Pulsed mood radiofrequency on dorsal root ganglion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed mood radiofrequency on dorsal root ganglionProcedure or surgery
- Pulsed radio frequency (PRF): PRF of the dorsal root ganglion (DRG) will be performed to all participants in this study. The procedures will be performed in the operating room under fluoroscopic guidance following radiation safety standards. The dorsal root ganglion of lumbosacral roots will be targeted. The patients will be positioned prone .Lidocaine 1% will be infiltrated at the skin entry site. A 10 cm, 22-gauge radiofrequency needle with a 5 mm curved active tip will be used. A radiculogram will be done to confirm appropriate placement and DRG will be stimulated for confirmation of the appropriate nerve root involved. Proximity of the needle to the DRG will be determined by appropriate sensory stimulation with 50 Hz (0.4-0.6 V), and motor stimulation at 2 Hz will be used to determine a threshold 1.5-2.0 times greater than the sensory threshold to avoid placement near the anterior nerve root. A pulsed lesion will be generated by applying 45 V to the DRG for 6 minutes at 42°C.
| Study group | Role | What they receive |
|---|---|---|
| patients with radicular pain recieved pulsed mood radiofrequency | Experimental | Investigation effect of neuroplasticity of patient on outcome of pulsed mood radiofrequency Receives: Procedure: Pulsed mood radiofrequency on dorsal root ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The functional outcome from using pulsed radiofrequency in treatment of patients with lumbar disc prolapse
Pre intervention serum BDNF
Measured: 6 months
Secondary outcomes (1)
The functional outcome from using pulsed radiofrequency in treatment of patients with lumbar disc prolapse
Pre intervention serum S100B
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Investigation the Role of BDNF and S100B Serum Level as a Predictive of Outcome of Pulsed Radiofrequency in Treatment Lumbar Disc Prolapse PatientsStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Fathy Hassan, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193461
- Sponsor's protocol ID
- FMBSUREC/06042021/FATHY-2
- Status last verified
- Jan 2022
- First submitted
- 2 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of SI00B and Brain Derived Neurotrophic Factor in Predicting Outcome From Using Pulsed Radiofrequency in Treatment of Patients With Lumbar Disc Prolapsed
- ClinicalTrials.gov ID
- NCT05193461
- Acronym / sponsor ID
- FMBSUREC/06042021/FATHY-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 18 Jan 2022 (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.
Chronic lumbar radicular (CLR) pain is a term used to describe neuropathic pain symptoms in the distribution of a particular lumbar nerve root due to disc protrusion, spinal stenosis, facet hypertrophy, or fibrosis after previous surgery. The pathophysiology of CLR pain involves mechanical, inflammatory, and immunologic factors that affect the function of the dorsal root ganglion (DRG).1Treatment methods include oral pain medications, physical therapy, epidural steroid injection (ESI) and surgery. 2,3.
Pulsed radiofrequency (PRF) was developed as a modification of the well-known radiofrequency ablation treatment. In conventional radiofrequency ablation, a high frequency alternating current is used to produce coagulative necrosis of the target nerve tissue without any selectivity for nociceptive fibers. However, in PRF, a current in short (20 msec) high voltage bursts is followed by silent phases (480 msec) which allow for heat dissemination, keeping the target tissue controlled below 42°C. 4,5 The mechanisms via which PRF causes analgesia are still not clearly understood, but laboratory experiments have highlighted some possible ways in which it might act, including its effects on neuropathic pain. Clinical use of PRF has been expanding, despite there being limited evidence of clinical efficacy in the form of randomized controlled trials (RCTs). 6 There have been few RCTs using PRF-DRG for radicular pain. Van Zundert et al performed an RCT in subjects with cervical radicular pain.7 Simopoulos et al did a pilot study on lumbar radicular pain, but the methodology included application of conventional radiofrequency over PRF in the study group and was not an efficacy trial. As such, the efficacy of PRF-DRG in CLR has never been determined. 8
Neuroplasticity or neuronal plasticity refers to the ability of the nervous system to do neuronal remodeling, formation of novel synapses and birth of new neurons. Neuronal plasticity is intimately linked to cellular responsiveness and may therefore be considered an index of the neuronal capability to restore its function. Failure of such mechanisms might enhance the susceptibility to neuronal injury.9 Neurotrophic factors (NTFs), and in particular the neurotrophin family, play an important role. In fact, besides their classical role in supporting neuronal survival, NTFs finely modulate all the crucial steps of network construction, from neuronal migration to experience-dependent refinement of local connections. It is now well established that NTFs are important mediators of neuronal plasticity also in adulthood where they modulate axonal and dendritic growth and remodeling, membrane receptor trafficking, neurotransmitter release, synapse formation and function.10 The neurotrophin brain-derived neurotrophic factor (BDNF) has emerged as crucial mediator of neuronal plasticity, suggesting that it might indeed bridge experience with enduring change in neuronal function.11BDNF acts on certain neurons of the central nervous system and the peripheral nervous system, helping to support survival of existing neurons, and encouraging growth and differentiation of new neurons and synapses.12,13 S100B belongs to the family ofcalcium binding proteins, is expressed mainly by astrocytesand is found both intra- and extracellularly in brain tissue. It was also reported that mature myelinating and non-myelinating Schwann cells of peripheral nerves strongly display S100 protein immunoreactivity (Stefansson et al., 1982; Sugimura et al., 1989; Vega et al., 1996).14 S100B can spill from injured cells and enter the extracellular space or bloodstream. Serum levels of S100B increase in patients with neuronal damage. Over the last decade, S100B has emerged as a candidate peripheral biomarker of neuronal injury. Elevated S100B levels accurately reflect the presence ofneurodegenerayion. Its potential clinical use in the therapeutic decisions is substantiated by a vast body of literature. Thus, the major advantage of using S100B is that its elevatio in serum provides a sensitive measure for determining neuronal injury at the molecular level before gross changes level.15
Detailed description
METHODS:
All patientswill be subjected to the following:
- Clinical assessment:
- Detailed history taking regarding: duration of pain, the presence of discogenic pain, radicular pain, responseto medical treatment, or previous interventional pain management
- Neurological examination: motor and sensory examination
- Assessment of the severity of the neurological symptoms before, 2 week, 1, 3 and 6 months after the interventional procedure by a physician who will be blinded to the patient's condition and the type of intervention. Modified Oswestry Back Disability Score (MODI): It consisted of low back pain disability index questionnaire about pain intensity, personal care, lifting, standing, walking, sitting, sleeping, social life, travelling and employment/homemaking. Thus, total 10 points; each had score range of 0-5. Hence, total score had range of 0-50. A high MODI score indicates a more severe functional disability related to the pain. Numeric Rating Scale (NRS-11): It is a scale for assessment of intensity of pain. It ranged from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.
- Assessment of patient's satisfaction about the intervention,2 week, 1, 3, and 6months after the interventional procedure by a physician who will be blinded to the patient's condition and the type of intervention.
The Short Assessment of Patient Satisfaction (SAPS): It consists of seven items assessing the core domains of patient satisfaction which include treatment satisfaction, explanation of treatment results, clinician care, participation in medical decision making, respect by the clinician, time with the clinician, and satisfaction with hospital/clinic care. Responses scales are 5-point scales. SAPS scores can be interpreted as follows: 0 to 10 = very dissatisfied, 11 to 18 = dissatisfied, 19 to 26 = satisfied, 27 to 28 = very satisfied.
- Radiological assessment:
Magnetic Resonance imaging (MRI):
Magnetic Resonance imaging of the lumbosacral spine will be performed for all patients included in the study.
The following protocols will be used:
- T1- weighted images (axial, sagittal).
- T2- weighted images (axial, coronal).
- Fluid attenuated inversion recovery (FLAIR) sequence. 3) Pulsed radio frequency (PRF): PRF of the dorsal root ganglion (DRG) will be performed to all participants in this study. The procedures will beperformed in the operating room under fluoroscopic guidance following radiation safety standards. The dorsal root ganglion of lumbosacral roots will be targeted. The patients will be positioned prone .Lidocaine 1% will be infiltrated at the skin entry site. A 10 cm, 22-gauge radiofrequency needle with a 5 mm curved active tip will be used. A radiculogram will be done to confirm appropriate placement and DRG will be stimulated for confirmation of the appropriate nerve root involved. Proximity of the needle to the DRG will be determined by appropriate sensory stimulation with 50 Hz (0.4-0.6 V), and motor stimulation at 2 Hz will be used to determine a threshold 1.5-2.0 times greater than the sensory threshold to avoid placement near the anterior nerve root. A pulsed lesion will be generated by applying 45 V to the DRG for 6 minutes at 42°C.
- Laboratory assessment
- Assessment of Brain Derived Neurotrophic Factor (BDNF) serum level:
Venous blood samples will be taken from all included patients before the interventional procedure and kept 30 minutes for clotting then centrifuged at 2,000-3,000 rpm for 20 minutes. Then, serum will be separated and kept under -80 c. The BDNF levels will be assessed using commercial sandwich-ELISA kits. The Microelisastripplatewill be pre-coated with an antibody specific to BDNF. Samples will be added to the appropriate Microelisastripplate wells and comoned to specific antibody. Then a Horseradish Peroxidase (HRP) conjugated antibody specific for BDNF will be added to each 'Microelisastripplate well and incubated. Free components will be washed away. The TMB substrate solution will be added to each well. Only those wells that contain BDNF and HRP conjugated BDNF antibody will appear blue and then turn to yellow after the addition of the stop solution. The optical density (OD) will be measured spectrophotometrically at a wavelength of 450 nm.
- Assessment of S100B serum level:
All participants will undergo quantitative assessment of serum S100B before the interventional procedure by applying a sandwich enzyme- linked immunoabsorbent assay technique (ELISA). Assays will be performed at the clinical and chemical pathology department, Beni-suef university hospital on an automated ELISA platform. Five mL of whole blood will be drawn from all included patients and put into a sterile plain tube. The blood samples will be centrifuged for twenty minutes at a speed 2000-3000 r.p.m. The supernatant serum will be collected and stored at -20 C till the time of analysis. Standard of S100B will be supplied as 120 microlitre containing 4000ng/L of S100B diluted by standard diluents to generate dilution range from 0 to 2000ng/L. Fifty mL of standard will be added to wells, they will be incubated for one hour at room temperature. The wells will be washed three times with washing solution (phosphate buffered saline, PH is from 7.0 to 7.2). 100 mL of conjugate will be added per each well. Each well will be washed again by washing solution five times. Fifty mL of substrate A (S100B horseradish peroxidase (HRP) conjugate) will be added to each well followed by addition of Fifty mL of substrate B (substrate for HRP enzyme containing small amount of 3,3,5,5 tetramethylbenzidine) then the wells will be covered and left at room temperature for ten minutes. Finally, fifty mL of stop solution (sulphuric acid) will be added to each well. Optical density will be read at 450 nm. The standard curve will be constructed using statistical software.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with radicular pain recieved pulsed mood radiofrequency | Experimental | Procedure: Pulsed mood radiofrequency on dorsal root ganglionInvestigation effect of neuroplasticity of patient on outcome of pulsed mood radiofrequency |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed as having symptomatic lumbar disc prolapse based on the following:
Key exclusion criteria (8 listed)
- The following patients will be excluded from the study:
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 |
|---|---|---|
| Pulsed mood radiofrequency on dorsal root ganglion3) Pulsed radio frequency (PRF): PRF of the dorsal root ganglion (DRG) will be performed to all participants in this study. The procedures will be performed in the operating room under fluoroscopic guidance following radiation safety standards. The dorsal root ganglion of lumbosacral roots will be targeted. The patients will be positioned prone .Lidocaine 1% will be infiltrated at the skin entry site. A 10 cm, 22-gauge radiofrequency needle with a 5 mm curved active tip will be used. A radiculogram will be done to confirm appropriate placement and DRG will be stimulated for confirmation of the appropriate nerve root involved. Proximity of the needle to the DRG will be determined by appropriate sensory stimulation with 50 Hz (0.4-0.6 V), and motor stimulation at 2 Hz will be used to determine a threshold 1.5-2.0 times greater than the sensory threshold to avoid placement near the anterior nerve root. A pulsed lesion will be generated by applying 45 V to the DRG for 6 minutes at 42°C. | Procedure or surgery | patients with radicular pain recieved pulsed mood radiofrequency |
Primary outcome
The functional outcome from using pulsed radiofrequency in treatment of patients with lumbar disc prolapse
Time frame: 6 months
Pre intervention serum BDNF
1 secondary outcome
The functional outcome from using pulsed radiofrequency in treatment of patients with lumbar disc prolapse
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed mood radiofrequency on dorsal root ganglion in people with Investigation the Role of BDNF and S100B Serum Level as a Predictive of Outcome of Pulsed Radiofrequency in Treatment Lumbar Disc Prolapse Patients, run by Beni-Suef 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wael Fathy, MD (+201006527133, drwaelfathy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The functional outcome from using pulsed radiofrequency in treatment of patients with lumbar disc prolapse (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2022.