Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patien… (NCT04444739) | Clinical Trial Compass
CompletedNot Applicable
Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis
Switzerland165 participantsStarted 2020-02-03
Plain-language summary
This study is to evaluate the correlation between muscle atrophy (MA), sagittal alignment, and stenosis degree in patients with lumbar spinal Stenosis (LSS). From existing radiological images, specific radiographic parameters will be extracted. General Information (Age, sex, levels of stenosis, duration of symptoms) will be extracted from patient files.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of degenerative lumbar spinal stenosis
* Upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral head
* MRI of the lumbar region with clear visibility of different muscle atrophy grade
* Consent that health related information can be used for research was signed
Exclusion Criteria:
* Other spinal disease such as severe scoliosis, fracture, spondylolisthesis and ankylosing spondylitis.
* Neuromuscular diseases such as M.Parkinson or multiple sclerosis
* Previous surgery of the spine
* Infection and/or malignancy tumor with involvement of the bony or soft tissue structures of the spine
* Presence of a documented consent dissent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severity of muscle atrophy (MA) from supine Magnetic Resonance Imaging (MRI) of lumbar spine
Timeframe: single time-point at baseline
2
Pelvic incidence (PI): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
Timeframe: single time-point at baseline
3
Severity of stenosis from supine MRI of lumbar spine
Timeframe: single time-point at baseline
4
Pelvic tilt (PT): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
Timeframe: single time-point at baseline
5
Sacral slope (SS): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
Timeframe: single time-point at baseline
6
Lumbar lordosis (LL): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads