Back to resultsUltrasound-CT Fusion Image-guided Minimally Invasive Interventional Treatment of Lumbosacral Nerve Roots
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ultrasound-CT fusion imaging
pure ultrasound guidance
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
1. Patients who need lumbar nerve root block treatment
Exclusion Criteria:
- Tumor patients
- Patients who have had lumbar spine surgery before
Sites / Locations
- Department of Ultrasound Diagnosis, Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasound-CT fusion imaging guidance
Pure ultrasound guidance
Arm Description
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance
Outcomes
Primary Outcome Measures
1 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective lumbar nerve root block puncture
3 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective
6 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective
Secondary Outcome Measures
Full Information
NCT ID
NCT04953520
First Posted
June 27, 2021
Last Updated
July 6, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04953520
Brief Title
Ultrasound-CT Fusion Image-guided Minimally Invasive Interventional Treatment of Lumbosacral Nerve Roots
Official Title
Ultrasound-CT Fusion Image-guided Minimally Invasive Interventional Treatment of Lumbosacral Nerve Roots
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 29, 2017 (Actual)
Primary Completion Date
June 16, 2018 (Actual)
Study Completion Date
January 16, 2019 (Actual)
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
The study is aimed at patients with low back and leg pain. The patients in the experimental group were guided by ultrasound-CT fusion imaging to insert the lumbar nerve root puncture needle.
Patients in the control group underwent the insertion of the lumbar nerve root puncture needle under the guidance of ultrasound alone.
Detailed Description
A total of 80 patients with low back and leg pain were randomly divided into two groups, 30 people in each group. The patients in the experimental group were guided by ultrasound-CT fusion imaging to insert the lumbar nerve root puncture needle.Patients in the control group underwent the insertion of the lumbar nerve root puncture needle under the guidance of ultrasound alone.Follow-up of VAS pain score after lumbar nerve root block treatment. This study aims to establish a standardized operation method and process for lumbosacral nerve ultrasound-CT fusion guided interventional pain treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound-CT fusion imaging guidance
Arm Type
Experimental
Arm Description
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging
Arm Title
Pure ultrasound guidance
Arm Type
Active Comparator
Arm Description
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
ultrasound-CT fusion imaging
Intervention Description
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging
Intervention Type
Procedure
Intervention Name(s)
pure ultrasound guidance
Intervention Description
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance
Primary Outcome Measure Information:
Title
1 month VAS pain score
Description
Patients undergo VAS pain score after the sonographer performs selective lumbar nerve root block puncture
Time Frame
VAS pain scores were performed 1 month after surgery
Title
3 month VAS pain score
Description
Patients undergo VAS pain score after the sonographer performs selective
Time Frame
VAS pain scores were performed 3 month after surgery
Title
6 month VAS pain score
Description
Patients undergo VAS pain score after the sonographer performs selective
Time Frame
VAS pain scores were performed 6 month after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Patients who need lumbar nerve root block treatment
Exclusion Criteria:
Tumor patients
Patients who have had lumbar spine surgery before
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ligang Cui
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Ultrasound Diagnosis, Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Ultrasound-CT Fusion Image-guided Minimally Invasive Interventional Treatment of Lumbosacral Nerve Roots
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