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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: ultrasound-CT fusion imaging; Procedure: pure ultrasound guidance

• Registration Number: NCT04953520
• Lead Sponsor: Peking University Third Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-12-29
• Primary Completion: 2018-06-16
• Study Completion: 2019-01-16
• 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: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

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