Status:
COMPLETED
Effect of Pulsed Mode Radiofrequency as a Treatment of Lumbar Disc Related Radicular Pain on Tumor Necrotic Factor α Level
Lead Sponsor:
Beni-Suef University
Conditions:
Lumbar Disc Herniation
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
Brief Summary
Lumbar radiculopathy is a term that describes symptoms of pain, numbness, and/or weakness that radiate along the sciatic nerve from the lower back to the buttocks and leg (1). Lumbar radiculopathy is ...
Detailed Description
This is a prospective randomized controlled trial that will be carried out on 80 patients diagnosed as having symptomatic lumbar disc prolapse. The study will be planned by taking the local ethics co...
Eligibility Criteria
Inclusion
- 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, not responding to conservative treatment and interfering with daily activities
- Radiological demonstration of posterolateral lumbar disc pulge by MRI lumbosacral
- Age range is between 30-80 years
Exclusion
- Patients with spinal deformities
- Patients with a previous history of spinal trauma
- Patients with previous spinal surgery
- 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
- Patient with pain rather than radicular neuropathic pain as Facet osteoarthritis, Sacroiliitis, Hip osteoarthritis, Discogenic, Pyriformis syndrome.
- Patients with contraindications to interventions (coagulopathy, sepsis, or allergy to the used drugs)
- 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
- History of G6PD deficiency in patients who are candidates to receive ozone therapy.
- Suspected spondylodiscitis.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05288920
Start Date
March 1 2022
End Date
October 1 2022
Last Update
December 14 2022
Active Locations (2)
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1
Mona Hussein
Banī Suwayf, Beni Suweif Governorate, Egypt, 62511
2
Beni-Suef University
Banī Suwayf, Egypt, 62511