Application of 3D Printing Guide Plate in Dorsal Root Ganglion Intervention Treatments

Peking University

Status: Unknown

Conditions: Lumbar Spinal Stenosis; Lumbar Disc Herniation

Treatments: Other: 3D printing guide plate; Other: Conventional guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT05403775

M2022206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

3D printing guide plate group

Experimental group

Description:

3D-printed customized guide plate will be used to guide the puncture in TFESI combined with dorsal root ganglion PRF.

Treatment:

Other: 3D printing guide plate

Conventional guidance group

Active Comparator group

Description:

The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy.

Treatment:

Other: Conventional guidance