Clinical trial NCT04688944: The Correlation Between Degeneration of Paraspinal Muscle and Outcome of Patients With Lumbar Spinal Stenosis
Official title: The Correlation Between Degeneration of Paraspinal Muscle and Outcome of Patients With Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spinal Stenosis
Paraspinal Muscle
Keywords: degeneration of paraspinal muscle
lumbar spinal stenosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients with lumbar spinal stenosis and 100 healthy people

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: cross-sectional area of paraspinal muscles
timeFrame: Baseline
measure: functional cross-sectional area of paraspinal muscles
timeFrame: Baseline
measure: Performance time of paraspinal muscle endurance test
timeFrame: Baseine
measure: lumbar stiffness disability index
timeFrame: the follow-up time of 3 months
measure: lumbar stiffness disability index
timeFrame: the follow-up time of 6 months
measure: lumbar stiffness disability index
timeFrame: the follow-up time of 12 months
measure: lumbar stiffness disability index
timeFrame: Baseline
measure: The Oswestry Disability Index
timeFrame: Baseline
measure: The Oswestry Disability Index
timeFrame: the follow-up time of 3 months
measure: The Oswestry Disability Index
timeFrame: the follow-up time of 6 months
measure: The Oswestry Disability Index
timeFrame: the follow-up time of 12 months
measure: Visual Analog Score
timeFrame: Baseline
measure: Visual Analog Score
timeFrame: the follow-up time of 3 months
measure: Visual Analog Score
timeFrame: the follow-up time of 6 months
measure: Visual Analog Score
timeFrame: the follow-up time of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: department of orthopaedic, peking university third hospital
name: weishi li
role: STUDY_CHAIR
References: