The Correlation Between Degeneration of Paraspinal Muscle and Outcome of Patients With Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

The Correlation Between Degeneration of Paraspinal Muscle and Outcome of Patients With Lumbar Spinal Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688944
• Other study ID #: M2019400
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Paraspinal Muscle
• Spinal Stenosis

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