Clinical trial NCT05403775: Application of 3D Printing Guide Plate in Dorsal Root Ganglion Intervention Treatments
Official title: Application of 3D Printing Guide Plate in Transforaminal Epidural Steroid Injection (TFESI) Combined With Pulsed Radiofrequency (PRF) Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disc Herniation
Lumbar Spinal Stenosis
Keywords: Transforaminal epidural steroid injection
Dorsal root ganglion pulsed radiofrequency
3D printing guide plate
Lumbosacral radicular pain
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.

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 the most common minimally invasive interventions for the treatment of LDH. TFESI combined with dorsal root ganglion pulsed radiofrequency (PRF) is an effective procedure for treating LSRP. Needle Puncture is the key technology in this procedure.

In the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. If the position of the needles is not satisfactory, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem is well solved by applying the 3D printing guide plate.

The application procedure for the the 3D printing guide plate: the model of the spine is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. The final position of needle is confirmed by C-arm fluoroscopy or CT.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old,
2. Chronic lumbosacral radicular pain lasting ≥12 weeks,
3. Dominant leg pain with less intense back pain,
4. The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
5. Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
6. 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,
7. Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features.

Exclusion Criteria:

1. Patient refusal to participate in the study,
2. Pregnant or nursing
3. Progressive motor weakness in the affected leg,
4. Allergies to local anesthetics, contrast dyes or steroids
5. Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
6. Presence of cancer accounting for back pain
7. Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
8. Steroid injection within the previous 12 weeks,
9. Systemic infection,
10. Injection site infection,
11. Unstable medical or psychiatric condition

Primary outcomes:
measure: C-arm fluoroscopy times
timeFrame: Intraoperative
Secondary outcomes:
measure: Puncture time
timeFrame: Intraoperative
measure: Numerical rating scale (NRS)
timeFrame: Postoperative 1 day, 1 month, 3 months
measure: MacNab
timeFrame: Postoperative 3 months
measure: Complications
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pain medicine center of Peking University Third Hospital
state: Beijing
Study officials:
References: