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

Lumbar Spinal Stenosis Clinical Trial

Official title:

Application of 3D Printing Guide Plate in Transforaminal Epidural Steroid Injection (TFESI) Combined With Pulsed Radiofrequency (PRF) Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05403775
• Other study ID #: M2022206
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Peking University Third Hospital
• Contact: Shuiqing Li, MD
• Phone: +86(010)82265026
• Email: bjfdfx[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Other:
• 3D printing guide plate
3D-printed customized guide plate will be used to guide the puncture in TFESI combined with dorsal root ganglion PRF to help to reduce intra-operative radiation.
• Conventional guidance
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy.

Locations

Country	Name	City	State
China	Pain medicine center of Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-arm fluoroscopy times	Numbers of using C-arm fluoroscopy	Intraoperative
Secondary	Puncture time	Time from the first puncture to the last puncture	Intraoperative
Secondary	Numerical rating scale (NRS)	NRS at One day, 1 month, 3 months after the operation	Postoperative 1 day, 1 month, 3 months
Secondary	MacNab	Patient satisfaction using the modified MacNab criteria	Postoperative 3 months
Secondary	Complications	Complication like nerve injury, blood, hemotoma, etc.	Intraoperative