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prospective clinical study ofthree-dimensional ultrasound reconstruction andnavigation system guided lumbar intervertebral puncture

prospective clinical study ofthree-dimensional ultrasound reconstruction andnavigation system guided lumbar intervertebral puncture

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128750
Enrollment
Unknown
Registered
2026-07-24
Start date
2026-08-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine-related low back pain

Interventions

one:Participants will undergo both puncture trajectory planning and needle placement for the lumbar intervertebral foramen under the guidance of a three-dimensional ultrasound navigation system.

Sponsors

General Hospital of the People's Liberation Army of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–70 years; 2. Symptoms and signs of lumbar radiculopathy persisting for at least 6 weeks; 3. Imaging findings corresponding to lumbar disc herniation (LDH); 4. Scheduled to undergo transforaminal epidural steroid injection (ESI) or percutaneous transforaminal endoscopic discectomy (PTED); if a patient received both transforaminal ESI and PTED on the same day, only the transforaminal ESI was included in the study; 5. Patients who signed the informed consent form preoperatively.

Exclusion criteria

Exclusion criteria: 1. Other diseases affecting the spine (tumor, infection, metabolic disease, immune system disease, or fracture); 2. Body mass index (BMI) >32 kg/m²; 3. Pregnancy; 4. Refusal to participate; 5. Severe psychiatric disorders precluding cooperation during the procedure; 6. Congenital spinal deformity or history of lumbar surgery.

Design outcomes

Primary

MeasureTime frame
First-time puncture success rate;number of punctures;Puncture time;Number of X-ray exposures;Path planning time;Angle deviation;Distance deviation;

Secondary

MeasureTime frame
Puncture confidence score;Intraoperative and postoperative complications;ODI score and VAS score before and after the surgery;Patient's satisfaction with the surgery and the modified MacNab efficacy score;

Countries

China

Contacts

Public ContactZhang Mingbo

General Hospital of the People's Liberation Army of China

owsifanduizhe@126.com+86 10 6693 7394

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026