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

NCT04688944 | Unknown

• 1 other identifier: M2019400
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Spinal Stenosis; Paraspinal Muscle

Keywords

degeneration of paraspinal muscle; lumbar spinal stenosis

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

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

healthy people

(1) age ≥ 45 years; (2) without chronic low back pain (LBP)

Interventions

observation OTHER

observation the difference between two groups

patients

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 patients with lumbar spinal stenosis and 100 healthy people

You may qualify if:

• patients with lumbar spinal stenosis
• age\>45 years old
• without other spinal disease
• without history of former spinal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• weishi li

  department of orthopaedic, peking university third hospital

  STUDY CHAIR

Central Study Contacts

weishi li, MD

CONTACT

13501358705; puh3liweishi@163.com

wei wang, MB

CONTACT

15600604778; 840839861@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: December 30, 2020
• Study Start: October 12, 2020
• Primary Completion: October 12, 2023
• Study Completion: January 21, 2024
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

CN (1)