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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
Sponsor:
Collaborator:
Møre og Romsdal Hospital Trust
Information provided by (Responsible Party):
Haukeland University Hospital

Brief 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.


Condition or disease
Degenerative Lumbar Spinal Stenosis Degenerative Spondylolisthesis

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. Time from inclusion until time for to surgery. [ Time Frame: 10 years ]
  5. 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 ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with symptomatic LSS with and without LDS referred to the participating orthopedic- or neurosurgical departments will be eligible for inclusion in the observational cohort. The burden of symptoms is considered not to be severe enough to opt for surgical treatment, and this conclusion is made through informed shared decision-making between surgeon and patient. Patients will be given verbal and written information about this observational study. If willing to participate, the patients sign an informed consent. The treatment of these patients will be pragmatic "usual care". There will not be any planned specific conservative treatment, but the surgeon can recommend specific conservative treatments in any case if preferred
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Frode G Rekeland, MD 56565800 ext +47 frode.rekeland@helse-bergen.no
Contact: Clemens Weber, Phd, MD clemens.weber@gmail.com

Locations
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Norway
Kysthospitalet i Hagavik, Orthopeadic clinic, Haukeland University Hospital Recruiting
Hagavik, Norway, 5217
Contact: Kari Indrekvam, Phd,MD         
Sponsors and Collaborators
Haukeland University Hospital
Møre og Romsdal Hospital Trust
Investigators
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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

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03562936     History of Changes
Other Study ID Numbers: 2011/2034-2
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:
LSS,DS

Additional relevant MeSH terms:
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Constriction, Pathologic
Spinal Stenosis
Spondylolisthesis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis