A clinical trial to evaluate the efficacy and safety of lumbar transforaminal epidural injection using an augmented reality navigation system
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0009265
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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