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

NCT05563636 | Completed

• 1 other identifier: AssiutU_HAA_RFA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuralgia; Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

• change in Oswestry Disability Index (ODI)

  assessing a change in Oswestry Disability Index (ODI)

  assessing a change in Change ODI from Baseline at 6 months

Study Arms (2)

control (group S)

OTHER

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

Device: standard pulsed radio frequency (PRF)

group H

EXPERIMENTAL

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.

Device: high-voltage long-term pulsed radio frequency (PRF)

Interventions

standard pulsed radio frequency (PRF) DEVICE

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.

Also known as: control group

control (group S)

high-voltage long-term pulsed radio frequency (PRF) DEVICE

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.

group H

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who have a history of lumbar spine surgery without instrumentation. , have clear symptoms of lumbar nerve root irritation, and unilateral lower extremity symptoms, and the straight leg raising test is positive

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Neuralgia; Failed Back Surgery Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Back Pain

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Amani H Abdel-wahab, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)