Study on the mechanism of Bushen Huoxue Recipe in the prevention and treatment of degenerative lumbar spinal stenosis based on multimodal in situ mass spectrometry imaging technology

Phase 1

Recruiting

• Conditions: Degenerative lumbar spinal stenosis

• Registration Number: ITMCTR2022000096
• Lead Sponsor: Medical Experimental Center of China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who meet the above diagnostic criteria and are clearly diagnosed as degenerative lumbar spinal stenosis, and those whose lumbar spine MRI showed thickening of the ligamentum flavum of the responsible segment >4mm were included in the experimental group.
2. Patients with burst fracture or lumbar spine trauma and no obvious lumbar degenerative disease on lumbar spine MRI were included.
3. Patients who are ineffective after conservative treatment for more than 3 months and have clear surgical indications must be routinely excluded from surgical treatment.
4. Age 40 to 75 years old.
5. Patients who participated voluntarily and signed informed consent.

Exclusion Criteria

1. Under the age of 40 or over 75, pregnant or breastfeeding women, patients with other spinal diseases such as ankylosing spondylitis, vertebral compression fractures and tumors.
2. Patients with definite lumbar spondylolisthesis of grade II or higher; patients who plan to undergo revision surgery with lumbar internal fixation.
3. Accompanied by ossification of the ligamentum flavum.
4. Combined with diabetes and other diseases that have a potential impact on the ligamentum flavum.
5. Special populations who are not suitable to participate in clinical research (blind, deaf, mute, intellectual or mental disorders, etc. who cannot cooperate with them).
6. Patients with serious primary diseases such as heart, brain, liver, kidney, hematopoietic system or other contraindications to surgery.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical tests;histopathology;Videography;Proteomics;Transcriptomics;