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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04964804

Collaborator

(none)

Enrollment

Location

Arms

14.5

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Procedure: real-time ultrasound-CT fusion imaging Procedure: ultrasound alone	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

May 14, 2015

Actual Study Completion Date :

May 14, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Procedure: real-time ultrasound-CT fusion imaging selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging
Active Comparator: ultrasound alone The control group underwent puncture under the guidance of ultrasound alone by sonographers	Procedure: ultrasound alone selective lumbar nerve root block puncture under the guidance of ultrasound alone

Arm

Intervention/Treatment

Experimental: 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

Procedure: real-time ultrasound-CT fusion imaging

selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging

Active Comparator: ultrasound alone

The control group underwent puncture under the guidance of ultrasound alone by sonographers

Procedure: ultrasound alone

selective lumbar nerve root block puncture under the guidance of ultrasound alone

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who need lumbar nerve root block treatment

Exclusion Criteria:

Tumor patients
Patients who have had lumbar spine surgery before

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ultrasound Diagnosis, Peking University Third Hospital	Beijing	Beijing	China	100191

Sponsors and Collaborators

Peking University Third Hospital

Investigators

Study Director: Jinrui Wang, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT04964804

Other Study ID Numbers:

M2016207

First Posted:

Jul 16, 2021

Last Update Posted:

Jul 16, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Low Back Pain

Study Results

No Results Posted as of Jul 16, 2021