Interventional Techniques for Managment of Chronic Low Back Pain

Comparative Study Between CT Guided and Fluoroscopic Guided Interventional Techniques for Management of Chronic Low Back Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: CT guided and Flouroscopic guided injection of corticosteroid and local anathesia

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abd El-Rahman A. Omar, A. lecturer; Phone Number: +201060300202; Email: abdelrahman.omar.radiologist@gmail.com

Study Locations

• Egypt
  • Assuit, Egypt, 71511
    • Recruiting
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Pain exacerbates by leaning forward and flexion of the body with numbness and tingling in the legs.
3. Visual analog scale (VAS) of pain severity ≥ 5 related specifically to the daily LBP.
4. Patient develops calf and leg pain of leg raising test.
5. No neurological motor deficits

Exclusion Criteria:

1. Evidance of progressive motor neurological deficits.
2. Magnetic resonance imaging show evidence of > 3 degenerated discs.
3. Intervertebral disc herniation ≥ 4 mm, disc sequestration, extrusion, disc space collapse or spondylolisthesis at the symptomatic level.
4. Moderate to severe central spinal canal or foraminal stenosis
5. Prior lumbar surgery of any kind at the same treatment level
6. Spinal fractures, deformities, infection or tumors.
7. History of uncontrolled coagulopathy or uncontrollable bleeding
8. Patients with psychotic illness, advanced hepatic, uncontrolled diabetic patients.
9. Current pregnancy, recent delivery (within 3-months of consent), or the intent of becoming pregnant during the study period.
10. Local sepsis or skin inflammatory in the back region.
11. Patients with red flags.
12. Neurologic findings (Fecal or urinary incontinence and cauda equina syndrome).
13. Persistent fever (infection).
14. Prolonged use of corticosteroids.
15. Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CT guided for patient with chronic low back pain; CT guided treatment in patients with low back pain	Other: CT guided and Flouroscopic guided injection of corticosteroid and local anathesia; 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.
Active Comparator: Flouroscopic guided for patient wit chronic low back pain; Flouroscopic guided treatment in patients with low back pain	Other: CT guided and Flouroscopic guided injection of corticosteroid and local anathesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Faculty Of Medicine, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: November 5, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CHRONIC LOW BACK PAIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No