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

Randomized Controlled Clinical Study to Validate the Clinical Accuracy and Safety of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen in Adults

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation; Percutaneous Endoscopic Lumbar Discectomy; Three-dimension Ultrasound; Learning Curves
• Intervention / Treatment: Device: Real-time 3D Xplane ultrasound

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: 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.
No Intervention: radiography group; The lumbar interforamen puncture was performed under the guidance of radiography with Mobile X-ray Image System (Arcadis Orbic 3D, Siemens, Germany) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the first success rate	the incidence of success on the first puncture of the target	during operation
number of punctures	number of punctures of the target	during operation
number of radiographies	number of radiographies during punctures	during operation
puncture time	how long hands are in contact with the needle	during operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operator confidence score	operator confidence score	Immediately after puncture
operative time	The time between the start of the surgery and the end of the surgery	Immediately after surgery
incidence of puncture relevant complications	neurovascular injury, cauda equina syndrome, dural tear, injection, hematoma and organ injury	The patient was examined for neurovascular injury immediately after the puncture. Other complications were observed 1 month after surgery
satisfaction of patients	satisfaction of patients(1-5points) from the last follow-up	1 month after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale of pain	pain scores (1-10) on the visual analog scale for waist and leg	The day before surgery and 1 month after surgery
Oswestry disability index	Oswestry disability index	The day before surgery and 1 month after surgery
modified Macnab criteria type	modified Macnab criteria type (excellent,good,fair,poor)	the last follow-up (at least 1 month after surgery)

Collaborators and Investigators

• Sponsor: Yi Mao
• Collaborators: National Natural Science Foundation of China

Publications and helpful links

General Publications

• GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum In: Lancet. 2019 Jun 22;393(10190):e44.
• Li YY, Liu YH, Yan L, Xiao J, Li XY, Ma J, Jia LG, Chen R, Zhang C, Yang Z, Zhang MB, Luo YK. Single-plane versus real-time biplane approaches for ultrasound-guided central venous catheterization in critical care patients: a randomized controlled trial. Crit Care. 2023 Sep 23;27(1):366. doi: 10.1186/s13054-023-04635-y.
• Zhang M, Yan L, Li S, Li Y, Huang P. Ultrasound-guided transforaminal percutaneous endoscopic lumbar discectomy: a new guidance method that reduces radiation doses. Eur Spine J. 2019 Nov;28(11):2543-2550. doi: 10.1007/s00586-019-05980-9. Epub 2019 May 13.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: ChinaPLAGH20230601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No