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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spinal Stenosis; Paraspinal Muscle
• Intervention / Treatment: Other: observation

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: weishi li, MD; Phone Number: 13501358705; Email: puh3liweishi@163.com
• Study Contact Backup: Name: wei wang, MB; Phone Number: 15600604778; Email: 840839861@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: wei wang, MB; Phone Number: 15600604778; Email: 840839861@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200 patients with lumbar spinal stenosis and 100 healthy people

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients; (1) age ≥ 45 years, (2) diagnosed LSS through a combination of clinical history, physical examination and radiological changes showing spinal canal stenosis on magnetic resonance imaging	Other: observation; observation the difference between two groups
healthy people; (1) age ≥ 45 years; (2) without chronic low back pain (LBP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
lumbar stiffness disability index	The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome.	Baseline
The Oswestry Disability Index	The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome.	Baseline
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
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
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
Visual Analog Score	Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome.	Baseline
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
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
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: weishi li, department of orthopaedic, peking university third hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Anticipated): October 12, 2023
• Study Completion (Anticipated): January 21, 2024

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: December 25, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: lumbar spinal stenosis; degeneration of paraspinal muscle
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: M2019400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No