Status:
UNKNOWN
Application of 3D Printing Guide Plate in Dorsal Root Ganglion Intervention Treatments
Lead Sponsor:
Peking University Third Hospital
Conditions:
Lumbar Disc Herniation
Lumbar Spinal Stenosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study applies 3D-printed customized guide plate in assisting the accurate puncture in transforaminal epidural steroid injection (TFESI) combined with pulsed radiofrequency (PRF) treatment. This t...
Detailed Description
Lumbar disc herniation (LDH) is a common degenerative spine disease and it can cause low back pain and lumbosacral radicular pain (LSRP). Transforaminal epidural steroid injection (TFESI) is one of th...
Eligibility Criteria
Inclusion
- Age ≥18 years old,
- Chronic lumbosacral radicular pain lasting ≥12 weeks,
- Dominant leg pain with less intense back pain,
- The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
- Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
- Segmental pain of a radicular nature originating from the lumbar segments and with a shooting or lancinating quality corresponding to a dermatome suggestive of the involved nerve root,
- Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features.
Exclusion
- Patient refusal to participate in the study,
- Pregnant or nursing
- Progressive motor weakness in the affected leg,
- Allergies to local anesthetics, contrast dyes or steroids
- Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
- Presence of cancer accounting for back pain
- Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
- Steroid injection within the previous 12 weeks,
- Systemic infection,
- Injection site infection,
- Unstable medical or psychiatric condition
Key Trial Info
Start Date :
July 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05403775
Start Date
July 8 2022
End Date
December 31 2023
Last Update
August 3 2022
Active Locations (1)
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1
Pain medicine center of Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191