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

Primary Purpose

Lumbar Disc Herniation, Lumbar Spinal Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3D printing guide plate
Conventional guidance
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Transforaminal epidural steroid injection, Dorsal root ganglion pulsed radiofrequency, 3D printing guide plate, Lumbosacral radicular pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pain medicine center of Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3D printing guide plate group

Conventional guidance group

Arm Description

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

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

Outcomes

Primary Outcome Measures

C-arm fluoroscopy times
Numbers of using C-arm fluoroscopy

Secondary Outcome Measures

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

Full Information

First Posted
May 30, 2022
Last Updated
August 2, 2022
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05403775
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Lumbar Spinal Stenosis
Keywords
Transforaminal epidural steroid injection, Dorsal root ganglion pulsed radiofrequency, 3D printing guide plate, Lumbosacral radicular pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D printing guide plate group
Arm Type
Experimental
Arm Description
3D-printed customized guide plate will be used to guide the puncture in TFESI combined with dorsal root ganglion PRF.
Arm Title
Conventional guidance group
Arm Type
Active Comparator
Arm Description
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy.
Intervention Type
Other
Intervention Name(s)
3D printing guide plate
Intervention Description
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
Intervention Name(s)
Conventional guidance
Intervention Description
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy.
Primary Outcome Measure Information:
Title
C-arm fluoroscopy times
Description
Numbers of using C-arm fluoroscopy
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Puncture time
Description
Time from the first puncture to the last puncture
Time Frame
Intraoperative
Title
Numerical rating scale (NRS)
Description
NRS at One day, 1 month, 3 months after the operation
Time Frame
Postoperative 1 day, 1 month, 3 months
Title
MacNab
Description
Patient satisfaction using the modified MacNab criteria
Time Frame
Postoperative 3 months
Title
Complications
Description
Complication like nerve injury, blood, hemotoma, etc.
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old, Chronic lumbosacral radicular pain lasting ≥12 weeks, Dominant leg pain with less intense back pain, The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications, Pain intensity≥4 out of 10 on the numerical rating scale (NRS), 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, Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features. Exclusion Criteria: Patient refusal to participate in the study, Pregnant or nursing Progressive motor weakness in the affected leg, Allergies to local anesthetics, contrast dyes or steroids Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging Presence of cancer accounting for back pain Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment Steroid injection within the previous 12 weeks, Systemic infection, Injection site infection, Unstable medical or psychiatric condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuiqing Li, MD
Phone
+86(010)82265026
Email
bjfdfx@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qipeng Luo, MD
Phone
+86(010)82265690
Email
1293194273@qq.com
Facility Information:
Facility Name
Pain medicine center of Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuiqing Li, MD
Phone
13581785098
Email
bjfdfx@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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