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

NCT ID: NCT04688944

Last Updated: 2022-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-12

Study Completion Date

2024-01-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lumbar Spinal Stenosis Paraspinal Muscle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

observation

Intervention Type OTHER

observation the difference between two groups

healthy people

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

No interventions assigned to this group

Interventions

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observation

observation the difference between two groups

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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weishi li

Role: STUDY_CHAIR

department of orthopaedic, peking university third hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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weishi li, MD

Role: CONTACT

13501358705

wei wang, MB

Role: CONTACT

15600604778

Facility Contacts

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wei wang, MB

Role: primary

15600604778

Other Identifiers

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M2019400

Identifier Type: -

Identifier Source: org_study_id

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