NCT05403775

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 3, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

May 30, 2022

Last Update Submit

August 2, 2022

Conditions

Lumbar Disc HerniationLumbar Spinal Stenosis

Keywords

Transforaminal epidural steroid injectionDorsal root ganglion pulsed radiofrequency3D printing guide plateLumbosacral radicular pain

Outcome Measures

Primary Outcomes (1)

  • C-arm fluoroscopy times

    Numbers of using C-arm fluoroscopy

    Intraoperative

Secondary Outcomes (4)

  • Puncture time

    Intraoperative

  • Numerical rating scale (NRS)

    Postoperative 1 day, 1 month, 3 months

  • MacNab

    Postoperative 3 months

  • Complications

    Intraoperative

Study Arms (2)

3D printing guide plate group

EXPERIMENTAL

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

Conventional guidance group

ACTIVE COMPARATOR

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

Other: Conventional guidance

Interventions

3D printing guide plateOTHER

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.

3D printing guide plate group
Conventional guidanceOTHER

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

Conventional guidance group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain medicine center of Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc DisplacementSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Shuiqing Li, MD

CONTACT

+86(010)82265026bjfdfx@126.com

Qipeng Luo, MD

CONTACT

+86(010)822656901293194273@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2022

First Posted

June 3, 2022

Study Start

July 8, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)