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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Disc Herniation; Lumbar Spinal Stenosis
• Intervention / Treatment: Other: 3D printing guide plate; Other: Conventional guidance

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuiqing Li, MD; Phone Number: +86(010)82265026; Email: bjfdfx@126.com
• Study Contact Backup: Name: Qipeng Luo, MD; Phone Number: +86(010)82265690; Email: 1293194273@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Pain medicine center of Peking University Third Hospital
      • Contact: Shuiqing Li, MD; Phone Number: 13581785098; Email: bjfdfx@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Conventional guidance group; The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy.	Other: Conventional guidance; The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-arm fluoroscopy times	Numbers of using C-arm fluoroscopy	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture time	Time from the first puncture to the last puncture	Intraoperative
Complications	Complication like nerve injury, blood, hemotoma, etc.	Intraoperative
Numerical rating scale (NRS)	NRS at One day, 1 month, 3 months after the operation	Postoperative 1 day, 1 month, 3 months
MacNab	Patient satisfaction using the modified MacNab criteria	Postoperative 3 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Transforaminal epidural steroid injection; 3D printing guide plate; Dorsal root ganglion pulsed radiofrequency; Lumbosacral radicular pain
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Spinal Stenosis
• Other Study ID Numbers: M2022206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No