A clinical trial to evaluate the efficacy and safety of lumbar transforaminal epidural injection using an augmented reality navigation system

Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Lumbar Cervical Interforaminal Epidural Nerve Block Using the Navigation Plus System, A Randomized, Single-blind, Single-center, Prospective trial (Investigator-initiated)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009265

Enrollment

Registered

2024-03-22

Start date

2023-03-29

Completion date

Unknown

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : All patients have four skin attachment markers placed on their back surface prior to the nerve block procedure. They then undergo CT imaging in the prone position. Before the procedur

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age 20 years or older 2) Neurological symptoms such as low back pain or unilateral lower extremity radicular pain due to adhesions or inflammation in the anterior epidural space of the lumbar spine based on imaging examination (CT or MRI) and physical examination. However, they do not show symptoms of paralysis or sensory loss. 3) Voluntarily agree to participate in the clinical trial and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1) blood coagulation disorder (INR > 1.5 or platelet count < 100,000/cm2 ) or taking anticoagulants 2) Have a systemic or injection site infection 3) Allergic to any medication (contrast, local anesthetic, steroids) 4) Allergic to adhesives (adhesives) 5) Pregnant or lactating women 6) Have difficulty prone position 7) Those who are considered for surgical treatment due to neurological impairment 8) Those who are unable to complete pain assessments or questionnaires for the study due to cognitive decline 9) Participation in other clinical trials within 1 month of the screening date 10) Other conditions that, in the opinion of the investigator, make participation in the study inappropriate.

Design outcomes

Primary

Measure	Time frame
The change in the time required for needle insertion into the foraminal space after needle insertion, comparing the control group with the group using the Navigation Plus system for transforaminal epidural injection.	—

Secondary

Measure	Time frame
The time required for needle insertion setup;The total procedure time for transforaminal epidural injection; The number of radiographic scans;Change in pain intensity (NRS) ;motor, sensory, reflex abnormality	—

Countries

Korea, Republic of

Contacts

Public ContactYookyung Jang

Korea University Anam Hospital

gamtang@gmail.com+82-2-920-5632

Outcome results