Lumbar Spinal StenosisNCT04688944
The Correlation Between Degeneration of Paraspinal Muscle and Outcome of Patients With Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis and Paraspinal Muscle, run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis, Paraspinal Muscle
- What is being tested?
- observation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2020to 21 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 patients with lumbar spinal stenosis and 100 healthy people
Who may be able to join
- patients with lumbar spinal stenosis
- age>45 years old
- without other spinal disease
- without history of former spinal surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
wei wang, MB, 15600604778, 840839861@qq.com
About this study
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.
Read the 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.
- Conditions
- Lumbar Spinal Stenosis, Paraspinal Muscle
- Being tested
- observation
- Keywords
- degeneration of paraspinal muscle, lumbar spinal stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation the difference between two groups
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: observation | |
| healthy people | (1) age ≥ 45 years; (2) without chronic low back pain (LBP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseine
lumbar stiffness disability index
The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
The Oswestry Disability Index
The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome.
Measured: Baseline
The Oswestry Disability Index
The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Visual Analog Score
Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome.
Measured: 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.
Measured: 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.
Measured: the follow-up time of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start12 Oct 2020
- Primary completion12 Oct 2023 (estimated)
- Study completion21 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- weishi li, Study chair, department of orthopaedic, peking university third hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688944
- Sponsor's protocol ID
- M2019400
- Status last verified
- Dec 2021
- First submitted
- 28 Jun 2020
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Degeneration of Paraspinal Muscle and Outcome of Patients With Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT04688944
- Acronym / sponsor ID
- M2019400
- Conditions
- Lumbar Spinal Stenosis, Paraspinal Muscle
- Keywords
- degeneration of paraspinal muscle, lumbar spinal stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 12 Oct 2023 (estimated)
- Study completion
- 21 Jan 2024 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | Other: observation(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 |
| healthy people | – | –(1) age ≥ 45 years; (2) without chronic low back pain (LBP) |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients with lumbar spinal stenosis and 100 healthy people
Key inclusion criteria (4 listed)
- patients with lumbar spinal stenosis
- age>45 years old
- without other spinal disease
- without history of former spinal surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationobservation the difference between two groups | Other | patients |
Primary outcome
cross-sectional area of paraspinal muscles
Time frame: Baseline
the cross-sectional area of paraspinal muscles reflects the quantity of paraspinal muscles. Higher cross-sectional area of paraspinal muscles means larger paraspinal muscle.
functional cross-sectional area of paraspinal muscles
Time frame: Baseline
functional cross-sectional area of paraspinal muscles reflects the quality of paraspinal muscles. It means the lean paraspinal muscle.
Performance time of paraspinal muscle endurance test
Time frame: Baseine
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).
lumbar stiffness disability index
Time frame: the follow-up time of 3 months
The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome
lumbar stiffness disability index
Time frame: the follow-up time of 6 months
The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome.
lumbar stiffness disability index
Time frame: the follow-up time of 12 months
The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome.
lumbar stiffness disability index
Time frame: Baseline
The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome.
The Oswestry Disability Index
Time frame: Baseline
The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome.
The Oswestry Disability Index
Time frame: the follow-up time of 3 months
The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome.
The Oswestry Disability Index
Time frame: the follow-up time of 6 months
The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome.
The Oswestry Disability Index
Time frame: the follow-up time of 12 months
The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome.
Visual Analog Score
Time frame: Baseline
Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome.
Visual Analog Score
Time frame: the follow-up time of 3 months
Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome.
Visual Analog Score
Time frame: the follow-up time of 6 months
Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome.
Visual Analog Score
Time frame: the follow-up time of 12 months
Visual Analog Score is used to evaluate pain,ranging from 0 to 10.Higher scores mean a worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
weishi li study chair
department of orthopaedic, peking university third hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis and Paraspinal Muscle, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact weishi li, MD (13501358705, puh3liweishi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cross-sectional area of paraspinal muscles (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.