The NORDSTEN Studies/The Observational Cohort Study (NORDSTEN/OS)
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|ClinicalTrials.gov Identifier: NCT03562936|
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : December 4, 2018
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.
|Condition or disease|
|Degenerative Lumbar Spinal Stenosis Degenerative Spondylolisthesis|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Prospective Observational Cohort Study of Patients With Symptomatic Degenerative Spinal Stenosis With and Without Degenerative Spondylolisthesis Not Scheduled for Surgery|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||October 1, 2018|
|Estimated Study Completion Date :||October 2029|
- Oswestry Disability Index (ODI) version 2.0 [ Time Frame: Baseline and follow-up at 2,5 and 10 years ]ODI is a patient reported outcome measure (PROM) comprising 10 sections where the patient is supposed to mark the most appropriate item. ODI scores range from 0 to 100, with higher score indicating more severe pain and disability. ODI is recommended by international expert panels for the evaluation of disability in clinical trials and commonly used by physicians treating patients with back-related symptoms. It has been translated and validated for applications with Norwegian patients. The change in ODI from baseline to follow-up will be registered.
- Zürich Claudication Questionnaire (ZCQ) [ Time Frame: Baseline and follow-up at 2,5 and 10 years ]A PROM evaluating disorder-specific functional capacity covering three domains: symptom severity (score 1-5), physical function (score 1-4), and patient satisfaction (Score 1-4) The change in ZCQ from baseline to follow-up will be registered
- Numeric Rating Scale (NRS) for back and leg pain. [ Time Frame: Baseline. Follow-up at 2,5 and 10 years ]NRS is a PROM that assesses self-reported pain from 0 (no pain) to 10 (the worst pain imaginable). The change in NRS for back- and leg pain from baseline to follow-up will be registered.
- EuroQol 5 dimensions questionnaire (EQ-5D). [ Time Frame: Baseline and follow-up at 2,5 and 10 years ]EQ-5D is a generic PROM for the evaluation of quality of life comprising 5 questions relating to mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each question has a three-point descriptive Likert-scale. Patient's answers are transformed into a scale ranging from -0.59 - 1.0 (1 equals perfect health). The change in EQ-5D from baseline to follow-up will be registered.
- Time from inclusion until time for to surgery. [ Time Frame: 10 years ]
- A questionnaire mapping subjective change of symptoms from baseline in a 6 point response scale, ranging from completely recovered to getting worse. [ Time Frame: Follow-up at 2,5 and 10 years ]
- A questionnaire mapping the satisfaction with living with the current state of symptoms for the rest of the life in a 5 point response scale, ranging from very satisfied to very dissatisfied. [ Time Frame: Follow-up at 2,5 and 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562936
|Contact: Frode G Rekeland, MD||56565800 ext +email@example.com|
|Contact: Clemens Weber, Phd, MDfirstname.lastname@example.org|
|Kysthospitalet i Hagavik, Orthopeadic clinic, Haukeland University Hospital||Recruiting|
|Hagavik, Norway, 5217|
|Contact: Kari Indrekvam, Phd,MD|
|Principal Investigator:||Frode G Rekeland, MD||Kysthospitalet i Hagavik, Orthopeadic clinic, Haukeland University Hospital|
|Study Chair:||Clemens Weber, PhD, MD||Stavanger University Hospital, Department for Neurosurgery|