Lumbar Spinal Stenosis Clinical Trial
Official title:
The Correlation Between Degeneration of Paraspinal Muscle and Outcome of Patients With Lumbar Spinal Stenosis
NCT number | NCT04688944 |
Other study ID # | M2019400 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 12, 2020 |
Est. completion date | January 21, 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
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 |
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