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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964804
• Other study ID #: M2016207
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: May 14, 2016

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 14, 2016
• Est. primary completion date: May 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients who need lumbar nerve root block treatment

Exclusion Criteria:

1. Tumor patients

2. Patients who have had lumbar spine surgery before

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Procedure:
• real-time ultrasound-CT fusion imaging
selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging
• ultrasound alone
selective lumbar nerve root block puncture under the guidance of ultrasound alone

Locations

Country	Name	City	State
China	Department of Ultrasound Diagnosis, Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	3 month VAS pain score	Patients undergo VAS pain score after the sonographer performs selective	VAS pain scores were performed 3 month after surgery
Primary	6 month VAS pain score	Patients undergo VAS pain score after the sonographer performs selective	VAS pain scores were performed 6 month after surgery
Primary	12 month VAS pain score	Patients undergo VAS pain score after the sonographer performs selective	VAS pain scores were performed 12 month after surgery