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

NCT04953520 | Completed

• 1 other identifier: M2017318
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

• 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

• 3 month VAS pain score

  Patients undergo VAS pain score after the sonographer performs selective

  VAS pain scores were performed 3 month after surgery

• 6 month VAS pain score

  Patients undergo VAS pain score after the sonographer performs selective

  VAS pain scores were performed 6 month after surgery

Study Arms (2)

Ultrasound-CT fusion imaging guidance

EXPERIMENTAL

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

Procedure: ultrasound-CT fusion imaging

Pure ultrasound guidance

ACTIVE COMPARATOR

The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance

Procedure: pure ultrasound guidance

Interventions

ultrasound-CT fusion imaging PROCEDURE

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

Ultrasound-CT fusion imaging guidance

pure ultrasound guidance PROCEDURE

The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance

Pure ultrasound guidance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients who need lumbar nerve root block treatment

You may not qualify if:

• Tumor patients
• Patients who have had lumbar spine surgery before

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Department of Ultrasound Diagnosis, Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ligang Cui

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 8, 2021
• Study Start: December 29, 2017
• Primary Completion: June 16, 2018
• Study Completion: January 16, 2019
• Last Updated: July 8, 2021

Record last verified: 2021-06

Locations

CN (1)