Back to resultsComparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
real-time ultrasound-CT fusion imaging
ultrasound alone
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
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
real-time ultrasound-CT fusion imaging
ultrasound alone
Arm Description
The experimental group of patients underwent selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging by sonographers
The control group underwent puncture under the guidance of ultrasound alone by sonographers
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
12 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective
Secondary Outcome Measures
Full Information
NCT ID
NCT04964804
First Posted
June 27, 2021
Last Updated
July 6, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04964804
Brief Title
Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block
Official Title
Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
May 14, 2015 (Actual)
Study Completion Date
May 14, 2016 (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 experimental group of patients underwent selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging by sonographers, and the control group underwent puncture under the guidance of ultrasound alone by sonographers.
Detailed Description
A total of 60 patients with low back and leg pain were randomly divided into two groups, 30 people in each group. Patients in the experimental group underwent selective lumbar nerve root block puncture under the real-time ultrasound-CT fusion imaging of the sonographer, and the control group underwent puncture under the sole ultrasound guidance of the sonographer. This study was used to compare the difference between the effects of pure ultrasound guidance and ultrasound-CT fusion imaging guidance on selective lumbar nerve root block.
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
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
real-time ultrasound-CT fusion imaging
Arm Type
Experimental
Arm Description
The experimental group of patients underwent selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging by sonographers
Arm Title
ultrasound alone
Arm Type
Active Comparator
Arm Description
The control group underwent puncture under the guidance of ultrasound alone by sonographers
Intervention Type
Procedure
Intervention Name(s)
real-time ultrasound-CT fusion imaging
Intervention Description
selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging
Intervention Type
Procedure
Intervention Name(s)
ultrasound alone
Intervention Description
selective lumbar nerve root block puncture under the guidance of ultrasound alone
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
Title
12 month VAS pain score
Description
Patients undergo VAS pain score after the sonographer performs selective
Time Frame
VAS pain scores were performed 12 month after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Jinrui Wang
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Ultrasound Diagnosis, Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block
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