The NORDSTEN Studies/The Observational Cohort Study (NCT03562936) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The NORDSTEN Studies/The Observational Cohort Study
Norway284 participantsStarted 2014-02
Plain-language summary
The NORDSTEN- OS(Observational study) aim to study the natural course in patients with mild to moderate symptomatic lumbar spinal stenosis with and without degenerative spondylolisthesis. 10 years follow-up is planned.
The NORDSTEN-OS is one of three studies in The NORwegian Degenerative Spondylolisthesis and Spinal STENosis studies.
The two other studies are:
NORDSTEN-SST (Spinal stenosis trial) (NCT02007083); a randomized controlled trial comparing the clinical and radiological results in three different decompression techniques in patients with lumbar spinal stenosis. The NORDSTEN-DS (Degenerative spondylolisthesis) (NCT02051374); a randomized controlled trial comparing the outcome of surgery with decompression without fixation and decompression with fixation in patients with lumbar spinal stenosis and concurrent degenerative spondylolisthesis.
Who can participate
Age range
18 Years – 80 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:
* Presence of clinical symptoms of spinal stenosis. Neurogenic claudication or radiating pain to one or both lower limbs
* Radiological findings corresponding to the clinical symptoms of LSS. Central stenosis or lateral recess stenosis with or without degenerative spondylolisthesis
* Able to understand Norwegian language, both spoken and written
* Able to give informed consent and to answer the questionnaires
* Over 18 years of age
Exclusion Criteria:
* Not willing to give written consent
* Participation in other clinical trial that may interfere with this trial
* American Society of Anesthesiologists (ASA) 4 or 5
* Age older than 80 years
* Not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physically)
* Presence of cauda equina syndrome (bowel and bladder dysfunction) or complete motor deficit
* Presence of an isthmic defect in pars interarticularis
* Former fracture of the thoracolumbar region
* Previous surgery in the lumbar region
* Distinct symptoms in one or both legs due to other diseases, e.g. polyneuropathy, vascular claudication or osteoarthritis
* Lumbosacral scoliosis of more than 20 degrees verified on standing x-ray AP-view
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
Oswestry Disability Index (ODI) version 2.0
Timeframe: Baseline and follow-up at 2,5 and 10 years