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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04688944
Other study ID # M2019400
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 12, 2020
Est. completion date January 21, 2024

Study information

Verified date December 2021
Source Peking University Third Hospital
Contact weishi li, MD
Phone 13501358705
Email puh3liweishi@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The photographical and functional parameters of paravertebral muscle in patients with lumbar spinal stenosis will be measured to investigate the correlation between paravertebral muscle degeneration and symptoms and prognosis of patients.By measuring the parameters of paravertebral muscle with normal people, the differences between the patients and normal people will be compared to establish an appropriate paravertebral muscle evaluation method.


Description:

It is a prospective observational study. This study will recruit 200 patients with lumbar spinal stenosis who will undertake posterior lumbar decompression and fusion surgery in our hospital.They all take preoperative lumbar mri examination and waist and back muscle strength test as well as recording their preoperative visual analogue scale,oswestry disability index, lumbar stiffness disability index score.All patients will receive a follow-up lasting for 1 year,and we will record patients outcomes,such as visual analogue scale,oswestry disability index and lumbar stiffness disability index score at each follow-up time. At the same time,we will recruit 100 healthy subjects without lumbar diseases or chronic lumbar pain. The difference of their age with patients was less than 5 years. Meanwhile, lumbar dorsal muscle strength test and lumbar mri examination were conducted, and visual analogue scale as well as oswestry disability index and lumbar stiffness disability index score was recorded in healthy subjects.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 21, 2024
Est. primary completion date October 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 90 Years
Eligibility Inclusion Criteria: - patients with lumbar spinal stenosis - age>45 years old - without other spinal disease - without history of former spinal surgery Exclusion Criteria: - With neuromuscular diseases - With hip joint or knee joint disease - Acute or severe chronic back pain of spinal stenosis that could interfere with the evaluation of endurance - Other serious diseases impacting the evaluation of endurance

Study Design


Intervention

Other:
observation
observation the difference between two groups

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary cross-sectional area of paraspinal muscles the cross-sectional area of paraspinal muscles reflects the quantity of paraspinal muscles. Higher cross-sectional area of paraspinal muscles means larger paraspinal muscle. Baseline
Primary functional cross-sectional area of paraspinal muscles functional cross-sectional area of paraspinal muscles reflects the quality of paraspinal muscles. It means the lean paraspinal muscle. Baseline
Primary Performance time of paraspinal muscle endurance test Participants were asked to lie prone on a plinth and lift their sternum from the plinth, raising their upper body.While maintaining this position, participants were asked to keep their arms in line with the body axis and not in contact with the plinth. Task failure was determined by a drop in the angle of trunk of greater than 10°at any point. The time was recorded until task failure or until the maximum contraction duration was reached (300 s). Baseine
Primary lumbar stiffness disability index The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome the follow-up time of 3 months
Primary lumbar stiffness disability index The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome. the follow-up time of 6 months
Primary lumbar stiffness disability index The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome. the follow-up time of 12 months
Primary lumbar stiffness disability index The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome. Baseline
Primary The Oswestry Disability Index The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome. Baseline
Primary The Oswestry Disability Index The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome. the follow-up time of 3 months
Primary The Oswestry Disability Index The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome. the follow-up time of 6 months
Primary The Oswestry Disability Index The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome. the follow-up time of 12 months
Primary Visual Analog Score Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome. Baseline
Primary Visual Analog Score Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome. the follow-up time of 3 months
Primary Visual Analog Score Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome. the follow-up time of 6 months
Primary Visual Analog Score Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome. the follow-up time of 12 months
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