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

July 6, 2021 updated by: Peking University Third Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Department of Ultrasound Diagnosis, Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-CT fusion imaging guidance
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging
Procedure: ultrasound-CT fusion imaging
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging
Active Comparator: Pure ultrasound guidance
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance
Procedure: pure ultrasound guidance
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 month VAS pain score
Time Frame: VAS pain scores were performed 1 month after surgery
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
Time Frame: VAS pain scores were performed 3 month after surgery
Patients undergo VAS pain score after the sonographer performs selective
VAS pain scores were performed 3 month after surgery
6 month VAS pain score
Time Frame: VAS pain scores were performed 6 month after surgery
Patients undergo VAS pain score after the sonographer performs selective
VAS pain scores were performed 6 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2017

Primary Completion (Actual)

June 16, 2018

Study Completion (Actual)

January 16, 2019

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2017318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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