Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started Mar 2015
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2016
CompletedFirst Submitted
Initial submission to the registry
June 27, 2021
CompletedFirst Posted
Study publicly available on registry
July 16, 2021
CompletedJuly 16, 2021
June 1, 2021
2 months
June 27, 2021
July 6, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
1 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective lumbar nerve root block puncture
VAS pain scores were performed 1 month after surgery
3 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective
VAS pain scores were performed 3 month after surgery
6 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective
VAS pain scores were performed 6 month after surgery
12 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective
VAS pain scores were performed 12 month after surgery
Study Arms (2)
real-time ultrasound-CT fusion imaging
EXPERIMENTALThe experimental group of patients underwent selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging by sonographers
ultrasound alone
ACTIVE COMPARATORThe control group underwent puncture under the guidance of ultrasound alone by sonographers
Interventions
selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging
selective lumbar nerve root block puncture under the guidance of ultrasound alone
Eligibility Criteria
You may qualify if:
- Patients who need lumbar nerve root block treatment
You may not qualify if:
- Tumor patients
- Patients who have had lumbar spine surgery before
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ultrasound Diagnosis, Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jinrui Wang
Peking University Third Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2021
First Posted
July 16, 2021
Study Start
March 1, 2015
Primary Completion
May 14, 2015
Study Completion
May 14, 2016
Last Updated
July 16, 2021
Record last verified: 2021-06