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Interventional Techniques for Managment of Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CT guided and Flouroscopic guided injection of corticosteroid and local anathesia
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with chronic radicular low back pain with unilateral or bilateral sciatica that persisted for more than 6 months and failed medical treatment for 6 weeks. Pain exacerbates by leaning forward and flexion of the body with numbness and tingling in the legs. Visual analog scale (VAS) of pain severity ≥ 5 related specifically to the daily LBP. Patient develops calf and leg pain of leg raising test. No neurological motor deficits Exclusion Criteria: Evidance of progressive motor neurological deficits. Magnetic resonance imaging show evidence of > 3 degenerated discs. Intervertebral disc herniation ≥ 4 mm, disc sequestration, extrusion, disc space collapse or spondylolisthesis at the symptomatic level. Moderate to severe central spinal canal or foraminal stenosis Prior lumbar surgery of any kind at the same treatment level Spinal fractures, deformities, infection or tumors. History of uncontrolled coagulopathy or uncontrollable bleeding Patients with psychotic illness, advanced hepatic, uncontrolled diabetic patients. Current pregnancy, recent delivery (within 3-months of consent), or the intent of becoming pregnant during the study period. Local sepsis or skin inflammatory in the back region. Patients with red flags. Neurologic findings (Fecal or urinary incontinence and cauda equina syndrome). Persistent fever (infection). Prolonged use of corticosteroids. Pregnancy.

Sites / Locations

  • Faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CT guided for patient with chronic low back pain

Flouroscopic guided for patient wit chronic low back pain

Arm Description

CT guided treatment in patients with low back pain

Flouroscopic guided treatment in patients with low back pain

Outcomes

Primary Outcome Measures

Control of pain by transforaminal epidural steroid injection combined with pulsed radio frequency guided by CT or fluoroscopy
Interventional radiologists already possess the technical skills necessary to perform these interventions effectively. Pulsed radiofrequency is one of the interventional therapies for LBP, which uses radiofrequency alternating current to ablate the tissue around the needle electrode. Transforaminal epidural steroid injection (TFESI), as a minimally invasive interventional surgery, is widely used in the treatment of LBP. It has the advantages of less trauma, fewer complications, and faster onset. It relieves symptoms by injecting corticosteroids and local anesthetics around the dural and nerve roots that cause radicular pain. TFESI combined with PRF for the treatment of RLBP effectively and rapidly relieve radicular pain, reduce VAS (visual analog scale), relieve pain symptoms, improve the quality of life, cure rate, and satisfaction of patients, as well as, achieve long-term remission.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2022
Last Updated
November 5, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05614596
Brief Title
Interventional Techniques for Managment of Chronic Low Back Pain
Official Title
Comparative Study Between CT Guided and Fluoroscopic Guided Interventional Techniques for Management of Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (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

5. Study Description

Brief Summary
Identify the efficacy of difference procedures of imaging guidance for needles for interventional treatments of low back pain (LBP) associated with sciatica and to study results and satisfaction of the patients between different groups.
Detailed Description
Low back pain (LBP) is a major cause of substantial disability. It is usually defined as pain, muscle tension, or stiffness localized below the costal margin and above the inferior gluteal folds, with or without leg pain (sciatica). Chronic low back pain is defined as the pain that persists for 12 weeks or longer without a response to treatment procedures or the improvement of the underlying cause. Radiculopathy or radicular pain occurs when specific lumbosacral nerve roots are affected, and radicular pain develops due to the irritation of the dorsal root ganglion (DRG). It is characterized by a lumbar pain irradiated to one or more lumbar or sacral dermatomes. Use of fluoroscopy and computed tomography has revolutionized the interventional treatments for chronic low back pain by providing excellent guidance to the needle placement, as well as recognizing improper placements such as intravascular or unintended intrathecal placements of needles and thus avoiding morbidity in the form of injury to the intra-spinal structures including spinal cord, nerve roots and blood vessels. Percutaneous guided interventions such as pulsed radiofrequency (PRF) and transforaminal epidural steroid injection (TFESI) guided by flouroscopy and computed tomography (CT) are safe and effective procedures for the management of chronic RLBP, which can be performed in an outpatient setting without sedation. Interventional radiologists already possess the technical skills necessary to perform these interventions effectively. Pulsed radiofrequency is one of the interventional therapies for LBP, which uses radiofrequency alternating current to ablate the tissue around the needle electrode. Transforaminal epidural steroid injection (TFESI), as a minimally invasive interventional surgery, is widely used in the treatment of LBP. It has the advantages of less trauma, fewer complications, and faster onset. It relieves symptoms by injecting corticosteroids and local anesthetics around the dural and nerve roots that cause radicular pain. TFESI combined with PRF for the treatment of RLBP effectively and rapidly relieve radicular pain, reduce VAS (visual analog scale), relieve pain symptoms, improve the quality of life, cure rate, and satisfaction of patients, as well as, achieve long-term remission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT guided for patient with chronic low back pain
Arm Type
Active Comparator
Arm Description
CT guided treatment in patients with low back pain
Arm Title
Flouroscopic guided for patient wit chronic low back pain
Arm Type
Active Comparator
Arm Description
Flouroscopic guided treatment in patients with low back pain
Intervention Type
Other
Intervention Name(s)
CT guided and Flouroscopic guided injection of corticosteroid and local anathesia
Intervention Description
Patients will be grouped into two groups, the first group (Group A) included patients who were subjected to fluoroscopic guided injection, and the second group (Group B) will include patients who were subjected to CT guided injections.
Primary Outcome Measure Information:
Title
Control of pain by transforaminal epidural steroid injection combined with pulsed radio frequency guided by CT or fluoroscopy
Description
Interventional radiologists already possess the technical skills necessary to perform these interventions effectively. Pulsed radiofrequency is one of the interventional therapies for LBP, which uses radiofrequency alternating current to ablate the tissue around the needle electrode. Transforaminal epidural steroid injection (TFESI), as a minimally invasive interventional surgery, is widely used in the treatment of LBP. It has the advantages of less trauma, fewer complications, and faster onset. It relieves symptoms by injecting corticosteroids and local anesthetics around the dural and nerve roots that cause radicular pain. TFESI combined with PRF for the treatment of RLBP effectively and rapidly relieve radicular pain, reduce VAS (visual analog scale), relieve pain symptoms, improve the quality of life, cure rate, and satisfaction of patients, as well as, achieve long-term remission.
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with chronic radicular low back pain with unilateral or bilateral sciatica that persisted for more than 6 months and failed medical treatment for 6 weeks. Pain exacerbates by leaning forward and flexion of the body with numbness and tingling in the legs. Visual analog scale (VAS) of pain severity ≥ 5 related specifically to the daily LBP. Patient develops calf and leg pain of leg raising test. No neurological motor deficits Exclusion Criteria: Evidance of progressive motor neurological deficits. Magnetic resonance imaging show evidence of > 3 degenerated discs. Intervertebral disc herniation ≥ 4 mm, disc sequestration, extrusion, disc space collapse or spondylolisthesis at the symptomatic level. Moderate to severe central spinal canal or foraminal stenosis Prior lumbar surgery of any kind at the same treatment level Spinal fractures, deformities, infection or tumors. History of uncontrolled coagulopathy or uncontrollable bleeding Patients with psychotic illness, advanced hepatic, uncontrolled diabetic patients. Current pregnancy, recent delivery (within 3-months of consent), or the intent of becoming pregnant during the study period. Local sepsis or skin inflammatory in the back region. Patients with red flags. Neurologic findings (Fecal or urinary incontinence and cauda equina syndrome). Persistent fever (infection). Prolonged use of corticosteroids. Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abd El-Rahman A. Omar, A. lecturer
Phone
+201060300202
Email
abdelrahman.omar.radiologist@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faculty Of Medicine
Organizational Affiliation
Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of medicine
City
Assuit
ZIP/Postal Code
71511
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Interventional Techniques for Managment of Chronic Low Back Pain

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