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

Yi Mao

Status: Completed

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

Treatments: Device: Real-time 3D Xplane ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06315803

ChinaPLAGH20230601

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Xplane ultrasound group

Experimental group

Description:

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).

Treatment:

Device: Real-time 3D Xplane ultrasound

radiography group

No Intervention group

Description:

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