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

December 28, 2021 updated by: Peking University Third Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

200 patients with lumbar spinal stenosis and 100 healthy people

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
observation the difference between two groups
healthy people
(1) age ≥ 45 years; (2) without chronic low back pain (LBP)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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).
Baseine
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
the follow-up time of 3 months
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.
the follow-up time of 6 months
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.
the follow-up time of 12 months
lumbar stiffness disability index
Time Frame: Baseline
The lumbar stiffness disability index ranges from 0 to 100. Higher scores mean a worse outcome.
Baseline
The Oswestry Disability Index
Time Frame: Baseline
The Oswestry Disability Index ranges from 0 to 100.Higher scores mean a worse outcome.
Baseline
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 follow-up time of 3 months
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 follow-up time of 6 months
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.
the follow-up time of 12 months
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.
Baseline
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.
the follow-up time of 3 months
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.
the follow-up time of 6 months
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.
the follow-up time of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: weishi li, department of orthopaedic, peking university third hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2019400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Spinal Stenosis

Clinical Trials on observation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings