Lumbar Disc HerniationNCT06315803
Randomized Controlled Clinical Study of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen
A study testing Real-time 3D Xplane ultrasound in people with Lumbar Disc Herniation and Percutaneous Endoscopic Lumbar Discectomy, run by Yi Mao at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Lumbar Disc Herniation, Percutaneous Endoscopic Lumbar Discectomy, Three-dimension Ultrasound
- What is being tested?
- Real-time 3D Xplane ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 to 80 years of age;
- symptoms and confirmatory signs of lumbar radiculopathy that persisted for at least 6 weeks;
- LDH at a corresponding level and side on imaging;
- 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.
Who cannot join
- other diseases affecting the spine (tumor, infection, metabolic disease, immune system disease and fractures);
- body mass index (BMI) greater than 32 kg/m2;
- pregnancy;
- refusal to participate;
- severe mental illnesses in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lumbar Disc Herniation, Percutaneous Endoscopic Lumbar Discectomy, Three-dimension Ultrasound, Learning Curves
- Being tested
- Real-time 3D Xplane ultrasound
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time 3D Xplane ultrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Real-time 3D Xplane ultrasound |
| 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) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
the first success rate
the incidence of success on the first puncture of the target
Measured: during operation
number of punctures
number of punctures of the target
Measured: during operation
number of radiographies
number of radiographies during punctures
Measured: during operation
puncture time
how long hands are in contact with the needle
Measured: during operation
Secondary outcomes (4)
operator confidence score
operator confidence score
Measured: Immediately after puncture
operative time
The time between the start of the surgery and the end of the surgery
Measured: Immediately after surgery
incidence of puncture relevant complications
neurovascular injury, cauda equina syndrome, dural tear, injection, hematoma and organ injury
Measured: 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
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start23 Jun 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yi Mao
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Yi Mao, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315803
- Sponsor's protocol ID
- ChinaPLAGH20230601
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37742018GBD 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.
PubMed 30496104Zhang 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.
PubMed 31087164
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study to Validate the Clinical Accuracy and Safety of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen in Adults
- ClinicalTrials.gov ID
- NCT06315803
- Acronym / sponsor ID
- ChinaPLAGH20230601
- Conditions
- Lumbar Disc Herniation, Percutaneous Endoscopic Lumbar Discectomy, Three-dimension Ultrasound, Learning Curves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Yi MaoUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xplane ultrasound group | Experimental | Device: Real-time 3D Xplane ultrasoundThe 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) . |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 16 to 80 years of age;
- symptoms and confirmatory signs of lumbar radiculopathy that persisted for at least 6 weeks;
- LDH at a corresponding level and side on imaging;
- 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.
Key exclusion criteria (5 listed)
- other diseases affecting the spine (tumor, infection, metabolic disease, immune system disease and fractures);
- body mass index (BMI) greater than 32 kg/m2;
- pregnancy;
- refusal to participate;
- severe mental illnesses in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time 3D Xplane ultrasoundAfter 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. | Device | Xplane ultrasound group |
Primary outcome
the first success rate
Time frame: during operation
the incidence of success on the first puncture of the target
number of punctures
Time frame: during operation
number of punctures of the target
number of radiographies
Time frame: during operation
number of radiographies during punctures
puncture time
Time frame: during operation
how long hands are in contact with the needle
4 secondary outcomes
operator confidence score
Time frame: Immediately after puncture
operative time
Time frame: Immediately after surgery
incidence of puncture relevant complications
Time frame: The patient was examined for neurovascular injury immediately after the puncture. Other complications were observed 1 month after surgery
satisfaction of patients
Time frame: 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 37742018Li 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.
- Results publication: PubMed 30496104GBD 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.
- Results publication: PubMed 31087164Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time 3D Xplane ultrasound in people with Lumbar Disc Herniation and Percutaneous Endoscopic Lumbar Discectomy, run by Yi Mao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the first success rate (time frame: during operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06315803, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.