Randomized Controlled Clinical Study of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-23

Study Completion Date

2024-02-01

Brief Summary

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The goal of this clinical trial is to compare Xplane ultrasound with radiography for guidance of lumbar interforamen puncture in patients with lumbar disc herniation. The main question\[s\] it aims to answer are:

* The feasibility that the Xplane ultrasound assists surgeon in mastering lumbar interforamen puncture faster than radiography.
* The clinical accuracy and safety of the Xplane ultrasound-guidance lumbar interforamen puncture faster.

Participants will undergo lumbar interforamen puncture with guidance of Xplane ultrasound or radiography. If there is a comparison group: Researchers will compare the first success rate, number of punctures, number of radiographies, puncture time and operator confidence score.

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Detailed Description

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Conditions

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Lumbar Disc Herniation Percutaneous Endoscopic Lumbar Discectomy Three-dimension Ultrasound Learning Curves

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

There are practical differences in operation and blind methods cannot be achieved.

Study Groups

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Xplane ultrasound group

The lumbar interforamen puncture was performed under the guidance of Xplane ultrasound with a X6-1 volume transducer probe (frequency range 1-6MHz, center frequency 3.2MHz).

Group Type EXPERIMENTAL

Real-time 3D Xplane ultrasound

Intervention Type DEVICE

After the puncture needle is in the skin, the longitudinal section of the Xplane mode can be adjusted to keep the needle in the proposed plane.

radiography group

The lumbar interforamen puncture was performed under the guidance of radiography with Mobile X-ray Image System (Arcadis Orbic 3D, Siemens, Germany) .

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Real-time 3D Xplane ultrasound

After the puncture needle is in the skin, the longitudinal section of the Xplane mode can be adjusted to keep the needle in the proposed plane.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 16 to 80 years of age;
2. symptoms and confirmatory signs of lumbar radiculopathy that persisted for at least 6 weeks;
3. LDH at a corresponding level and side on imaging;
4. surgical candidates for epidural steroid injection (ESI) or percutaneous endoscopic lumbar discectomy (PELD). If the patient underwent ESI and PELD surgery on the same day, we only selected the data for the first one.

Exclusion Criteria

1. other diseases affecting the spine (tumor, infection, metabolic disease, immune system disease and fractures);
2. body mass index (BMI) greater than 32 kg/m2;
3. pregnancy;
4. refusal to participate;
5. severe mental illnesses in the trial.

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No