Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: ultrasound alone; Procedure: real-time ultrasound-CT fusion imaging

• Registration Number: NCT04964804
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2015-03-01
• Primary Completion: 2015-05-14
• Study Completion: 2016-05-14
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Study First Posted: 2021-07-16
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients who need lumbar nerve root block treatment

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Exclusion Criteria

1. Tumor patients
2. Patients who have had lumbar spine surgery before

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound alone	ultrasound alone	The control group underwent puncture under the guidance of ultrasound alone by sonographers
real-time ultrasound-CT fusion imaging	real-time ultrasound-CT fusion imaging	The experimental group of patients underwent selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging by sonographers

Primary Outcome Measures

Name	Time	Method
1 month VAS pain score	VAS pain scores were performed 1 month after surgery	Patients undergo VAS pain score after the sonographer performs selective lumbar nerve root block puncture
3 month VAS pain score	VAS pain scores were performed 3 month after surgery	Patients undergo VAS pain score after the sonographer performs selective
6 month VAS pain score	VAS pain scores were performed 6 month after surgery	Patients undergo VAS pain score after the sonographer performs selective
12 month VAS pain score	VAS pain scores were performed 12 month after surgery	Patients undergo VAS pain score after the sonographer performs selective

Trial Locations

Locations (1)

Department of Ultrasound Diagnosis, Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China