Comparative Effectiveness and Prognostic Factors of Surgical and Non-surgical Management of Lumbar Spinal Stenosis
NCT ID: NCT03548441
Last Updated: 2018-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2017-01-31
2020-09-30
Brief Summary
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Materials and analysis: This observational study is designed to investigate the course of treatment, compare effectiveness of surgical and non-surgical treatment in patients with lumbar spinal stenosis, and identify prognostic factors for outcome in the context of current clinical practice. Prospectively registered data on treatment, outcome and patient characteristics are collected from nationwide registers on health and social issues, a clinical registry of people with chronic back pain and hospital medical records. Primary outcome is change in physical function measured by the Zurich Claudication Questionnaire. Secondary outcomes are changes in symptom severity, pain-related function, health-related quality of life, and general self-efficacy. All outcomes are measured at baseline, 6 months and 12 months follow up. Comparisons on these variables will be made between those who undergo surgery for lumbar spinal stenosis and those not receiving surgery at 12 months follow up according to different analysis populations. Prognostic factors include treatment allocation, back and leg pain intensity, comorbidity, duration of symptoms, pre-treatment function, self-rated health, income, general self-efficacy and magnetic resonance imaging graded compression of central stenosis.
Ethics and dissemination: The study has been evaluated by The Regional Committees on Health Research for Southern Denmark (S-20172000-200) and notified to the Danish Data Protection Agency (17/30636). All participants provide consent. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences following the guidance from the STROBE and PROGRESS statement. Potential sources of bias will be addressed using ROBINS-I.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgery
Exposed
Surgery
Patients receiving surgical treatment undergo various types of posterior decompressive surgery with or without spinal fusion. The method used for decompressive surgery or fusions is determined solely by the surgeon.
Non-surgical management
Non-exposed
Non-surgical management
Patients managing lumbar spinal stenosis non-surgically are either referred to rehabilitation primary health care center or referred back to their general practitioner for treatment. Treatment may include physiotherapy, chiropractic treatment, lifestyle changes and/or pain management. Post-surgically patients may also be referred to rehabilitation at a primary health care center.
Interventions
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Surgery
Patients receiving surgical treatment undergo various types of posterior decompressive surgery with or without spinal fusion. The method used for decompressive surgery or fusions is determined solely by the surgeon.
Non-surgical management
Patients managing lumbar spinal stenosis non-surgically are either referred to rehabilitation primary health care center or referred back to their general practitioner for treatment. Treatment may include physiotherapy, chiropractic treatment, lifestyle changes and/or pain management. Post-surgically patients may also be referred to rehabilitation at a primary health care center.
Eligibility Criteria
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Inclusion Criteria
2. ICD-10 diagnosis of degenerative lumbar spinal stenosis registered in the nationwide patient registry between January 1st - December 31st 2017.
3. Included in the SpineData registry.
4. Give consent to use patient-reported data for research purposes
Exclusion Criteria
61 Years
ALL
No
Sponsors
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University of Southern Denmark
OTHER
Parker Research Institute
OTHER
Odense University Hospital
OTHER
University College South Denmark
OTHER
University of Aarhus
OTHER
Defactum, Central Denmark Region
OTHER_GOV
Spine Centre of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Helle A Brøgger, MSc
Role: PRINCIPAL_INVESTIGATOR
1) Spine Centre of Southern Denmark, 2) University of Southern Denmark, 3) The Parker Research Institute, 4) University College South Denmark
Robin Christensen, PhD
Role: STUDY_DIRECTOR
1) The Parker Research Institute 2) Odense University Hospital
Thomas Maribo, PhD
Role: STUDY_DIRECTOR
1) Aarhus University 2) DEFACTUM
Berit Schiøttz-Christensen, PhD
Role: STUDY_CHAIR
1) Spine Centre of Southern Denmark, 2) University of Southern Denmark
Locations
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Spine Centre of Souther Denmark
Middelfart, Fyn, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Brogger HA, Maribo T, Christensen R, Schiottz-Christensen B. Comparative effectiveness and prognostic factors for outcome of surgical and non-surgical management of lumbar spinal stenosis in an elderly population: protocol for an observational study. BMJ Open. 2018 Dec 19;8(12):e024949. doi: 10.1136/bmjopen-2018-024949.
Other Identifiers
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17/30636
Identifier Type: -
Identifier Source: org_study_id
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