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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xplane ultrasound group | Experimental | 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). |
|
| radiography group | No Intervention | The lumbar interforamen puncture was performed under the guidance of radiography with Mobile X-ray Image System (Arcadis Orbic 3D, Siemens, Germany) . |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-time 3D Xplane ultrasound | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37742018 | Background | 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. | |
| 30496104 |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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There are practical differences in operation and blind methods cannot be achieved.
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| 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 |
| 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) |
| 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. |
| 31087164 | Result | 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |