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

NCT ID: NCT05403775

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2023-12-31

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.

Conditions

Lumbar Disc Herniation; Lumbar Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3D printing guide plate group

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

Group Type: EXPERIMENTAL

3D printing guide plate

Intervention Type: OTHER

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 group

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

Group Type: ACTIVE_COMPARATOR

Conventional guidance

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Conventional guidance

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pain medicine center of Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuiqing Li, MD

Role: CONTACT

bjfdfx@126.com

+86(010)82265026

Qipeng Luo, MD

Role: CONTACT

1293194273@qq.com

+86(010)82265690

Facility Contacts

Shuiqing Li, MD

Role: primary

bjfdfx@126.com

13581785098

Other Identifiers

M2022206

Identifier Type: -

Identifier Source: org_study_id