Ultrasound-CT Fusion Image-guided Minimally Invasive Interventional Treatment of Lumbosacral Nerve Roots

Low Back Pain Clinical Trial

Official title:

Ultrasound-CT Fusion Image-guided Minimally Invasive Interventional Treatment of Lumbosacral Nerve Roots

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04953520
• Other study ID #: M2017318
• Status: Completed
• Phase: N/A
• Start date: December 29, 2017
• Est. completion date: January 16, 2019

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 16, 2019
• Est. primary completion date: June 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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:
• ultrasound-CT fusion imaging
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging
• pure ultrasound guidance
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance

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