Interventional Techniques for Managment of Chronic Low Back Pain

NCT05614596 | Unknown

• 1 other identifier: chronic low back pain
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CT guided for patient with chronic low back pain

ACTIVE COMPARATOR

CT guided treatment in patients with low back pain

Other: CT guided and Flouroscopic guided injection of corticosteroid and local anathesia

Flouroscopic guided for patient wit chronic low back pain

ACTIVE COMPARATOR

Flouroscopic guided treatment in patients with low back pain

Other: CT guided and Flouroscopic guided injection of corticosteroid and local anathesia

Interventions

CT guided and Flouroscopic guided injection of corticosteroid and local anathesia OTHER

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.

CT guided for patient with chronic low back pain; Flouroscopic guided for patient wit chronic low back pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine

Asyut, 71511, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Faculty Of Medicine

  Assiut University

  STUDY CHAIR

Central Study Contacts

Abd El-Rahman A. Omar, A. lecturer

CONTACT

+201060300202; abdelrahman.omar.radiologist@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: November 14, 2022
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

EG (1)