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High Voltage VS Standard Voltage Radiofrequency in a Patient With Failed Back Surgery Syndrome

Primary Purpose

Neuralgia, Failed Back Surgery Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
standard pulsed radio frequency (PRF)
high-voltage long-term pulsed radio frequency (PRF)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have a history of lumbar spine surgery, have clear symptoms of lumbar nerve root irritation, and unilateral lower extremity symptoms, and the straight leg raising test is positive

Exclusion Criteria:

  • Mechanical compression to nerve root
  • Spondylolisthesis, retrolithesis
  • Spondylodiscitis
  • Lumbar canal stenosis
  • Inflammatory low back pain
  • Coagulopathy
  • Local anesthetic allergy
  • Infection at the site of injection
  • Systemic infection

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control (group S)

group H

Arm Description

patients will be given standard PRF treatment: temperature 42 ℃, frequency 2 Hz, pulse width 20 ms, voltage 37-41 V, time 120 s.

patients will be given high-voltage long-term PRF treatment: temperature 42 ℃, frequency 2 Hz, pulse width 20 ms, the voltage range of 50-90 V, At the beginning, the patient will feel a severe burning sensation in the original pain area, and slowly after the patient tolerates it. Increase the voltage and gradually increase to the maximum voltage that the patient can tolerate (up to 70-90 V) until the end of 900 s.

Outcomes

Primary Outcome Measures

change in Oswestry Disability Index (ODI)
assessing a change in Oswestry Disability Index (ODI)

Secondary Outcome Measures

Full Information

First Posted
September 28, 2022
Last Updated
July 24, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05563636
Brief Title
High Voltage VS Standard Voltage Radiofrequency in a Patient With Failed Back Surgery Syndrome
Official Title
Efficacy of High Voltage VS Standard Voltage Radiofrequency on Unilateral Lower Limb Neuralgia in a Patient With Failed Back Surgery Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Postoperative lumbar spine pain syndrome (FBSS) refers to patients who have undergone surgery for lumbar spine disease one or more times and still have intractable lumbosacral pain after surgery, with or without lower limb sensory and motor dysfunction. Pain is the main reason for reducing patients' quality of life. Hussain and Erdek believe that despite up to 3 months of postoperative intervention, pain may still exist. Since persistent pain seriously affects patients' daily life and work, optimizing the FBSS treatment plan and improving the quality of life of FBSS patients cannot be ignored. At present, the treatment methods for neuropathic pain radiated to the lower extremity after lumbar spine surgery mainly include oral drug therapy, nerve block, pulsed radio frequency (PRF) and spinal cord electrical stimulation, and other minimally invasive interventional methods. Still, there is no domestic or foreign treatment method is reported in the literature to be effective.
Detailed Description
Selective nerve root PRF is an effective method for treating neuropathic pain, but its analgesic mechanism is still unclear. The traditional PRF adopts the standard 42 ℃ mode, but due to its low voltage (40 V), short duration (120 s), and limited intensity of action, the patient cannot get the best therapeutic effect. In recent years, high-voltage long-term PRF has been gradually applied to treating neuropathic pain such as postherpetic neuralgia, trigeminal neuralgia, and glossopharyngeal neuralgia, and achieved ideal results. . Selective spinal nerve puncture under ultrasound and X-ray guidance: After the patient enters the operating room, the venous access is inserted, and the patient is placed in a prone position. ECG monitoring is given, and the patient's vital signs are continuously monitored. Routine sterilization and laying of sheets, puncture with an 20 G radiofrequency puncture needle under the guidance of ultrasound, repeated X-rays to confirm the position of the needle tip, when the needle tip reaches the target position, the X-ray front view will show that the needle tip of the puncture needle is located below the pedicle, and the lateral view shows The tip of the puncture needle is located at the posterior 1/2of the intervertebral foramen, then connect the radiofrequency treatment apparatus, perform sensory and motor tests, and perform sensory tests The pain in the corresponding innervated area is reproduced within 0.5 V and 50 Hz, and is consistent with the patient's original pain location; if >0.5 V does not induce pain in the original pain area, fine-tune the needle tip position and then perform the sensory test until 0.1 The needle tip position can be fixed when the patient's original pain can be induced within ~0.5 V. In the exercise test, muscle beats in the corresponding area were induced within 1.0 V and 2 Hz. After the test was successful, 1 ml of contrast agent will be injected, and the X-ray should show that the contrast agent spread along the nerve root and epidural space.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Failed Back Surgery Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control (group S)
Arm Type
Other
Arm Description
patients will be given standard PRF treatment: temperature 42 ℃, frequency 2 Hz, pulse width 20 ms, voltage 37-41 V, time 120 s.
Arm Title
group H
Arm Type
Experimental
Arm Description
patients will be given high-voltage long-term PRF treatment: temperature 42 ℃, frequency 2 Hz, pulse width 20 ms, the voltage range of 50-90 V, At the beginning, the patient will feel a severe burning sensation in the original pain area, and slowly after the patient tolerates it. Increase the voltage and gradually increase to the maximum voltage that the patient can tolerate (up to 70-90 V) until the end of 900 s.
Intervention Type
Device
Intervention Name(s)
standard pulsed radio frequency (PRF)
Other Intervention Name(s)
control group
Intervention Description
patients will be given standard pulsed radiofrequency (PRF) treatment: temperature 42 ℃, frequency 2 Hz, pulse width 20 ms, voltage 37-41 V, time 120 s.
Intervention Type
Device
Intervention Name(s)
high-voltage long-term pulsed radio frequency (PRF)
Intervention Description
patients will be given standard pulsed radiofrequency (PRF) treatment: temperature 42 ℃, frequency 2 Hz, pulse width 20 ms, voltage 50-90 V, At the beginning, the patient will feel a severe burning sensation in the original pain area, and slowly after the patient tolerates it. Increase the voltage and gradually increase to the maximum voltage that the patient can tolerate (up to 70-90 V) until the end of 900 s.
Primary Outcome Measure Information:
Title
change in Oswestry Disability Index (ODI)
Description
assessing a change in Oswestry Disability Index (ODI)
Time Frame
assessing a change in Change ODI from Baseline at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have a history of lumbar spine surgery, have clear symptoms of lumbar nerve root irritation, and unilateral lower extremity symptoms, and the straight leg raising test is positive Exclusion Criteria: Mechanical compression to nerve root Spondylolisthesis, retrolithesis Spondylodiscitis Lumbar canal stenosis Inflammatory low back pain Coagulopathy Local anesthetic allergy Infection at the site of injection Systemic infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amani H Abdel-wahab, MD
Phone
+201004610623
Email
amanyabdelwhab@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amani H Abdel-wahab, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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High Voltage VS Standard Voltage Radiofrequency in a Patient With Failed Back Surgery Syndrome

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