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Comparative Effectiveness and Prognostic Factors of Surgical and Non-surgical Management of Lumbar Spinal Stenosis

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ClinicalTrials.gov Identifier: NCT03548441
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborators:
University of Southern Denmark
Parker Research Institute
Odense University Hospital
University College South Denmark
University of Aarhus
Defactum, Central Denmark Region
Information provided by (Responsible Party):
Spine Centre of Southern Denmark

Brief Summary:

Introduction: Lumbar spinal stenosis is a common cause of low back and leg pain in elderly impacting physical activity and quality of life. Initial treatments are non-surgical options. If unsuccessful, surgery is advocated. The literature is not clear as to the outcome of surgery when compared to non-surgical treatment, and the optimal time for surgery is not explicit.

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.


Condition or disease Intervention/treatment
Lumbar Spinal Stenosis Procedure: Surgery Other: Non-surgical management

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: 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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Group/Cohort Intervention/treatment
Surgery
Exposed
Procedure: 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
Other: 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.




Primary Outcome Measures :
  1. Physical function [ Time Frame: Between baseline and 12 months follow up ]

    Change in physical function score in the Zurich Claudication Questionnaire (ZCQ) collected through a clinical registry of people with chronic back pain (SpineData).

    The ZCQ is a condition-specific self-reported measure of symptom severity, physical function and satisfaction with treatment in patients with lumbar spinal stenosis.

    The questionnaire is composed of three domains (subscales) with a Likert-type scale.

    The physical function subscale includes 6 items addressing walking distance and walking ability. All but one item have Likert response scales with 4 categories.

    The physical function subscale score is calculated from the unweighted mean of all answered items.

    The possible range of the score is 1 to 4.

    Lower scores indicate less disability.



Secondary Outcome Measures :
  1. Symptom severity [ Time Frame: Between baseline and 12 months follow up ]

    Change in symptom severity score in the Zurich Claudication Questionnaire (ZCQ) collected through a clinical registry of people with chronic back pain (SpineData).

    The ZCQ is a condition-specific self-reported measure of symptom severity, physical function and satisfaction with treatment in patients with lumbar spinal stenosis.

    The questionnaire is composed of three domains (subscales) with a Likert-type scale.

    The symptom severity subscale includes 7 items addressing pain, numbness, weakness and balance disturbances. All but one item have Likert response scales with 5 categories.

    The possible range of the score is 1 to 5.

    Lower scores express less symptom severity.


  2. Pain related physical function [ Time Frame: Between baseline and 12 months follow up ]

    Change in Oswestry Disability Index collected through a clinical registry of people with chronic back pain (SpineData).

    The Oswestry Disability Index (ODI) is a region-specific questionnaire for assessing self-reported levels of disability for patients with spinal disorders.

    The questionnaire contains 10 pain related sections (items) with 6 response options (statements). Each section of six response options is scored from 0 (no pain) to 5 (most severe pain).

    For each section of six statements the total score is 5; if the first statement is marked, the score equals 0; if the last (6th) statement is marked, the score equals 5. If more than one box is marked in each section, the highest score is used.

    The section scores are summarised to a total score, ranging from 0-100. Scores are expressed as a percentage of total points.

    Lower scores indicate less disability.


  3. Health related quality of life [ Time Frame: Between baseline and 12 months follow up ]

    Change in health related quality of life measured by EQ-5D-3L collected through a clinical registry of people with chronic back pain (SpineData).

    The EQ-5D-3L is a generic self-reported instrument for measuring health-related quality of life consisting of a descriptive system and the EQ visual analogue scale (EQ VAS).

    The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each with 3 response options.

    These are converted into a single summary index by applying preference weights obtained from the general population with a total score ranging from -0.6 to 1, where 1 corresponds to perfect health and 0 to death.

    Higher scores indicate better health related quality of life,

    The EQ VAS is a vertical, visual analogue scale scoring patients self-rated health ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Higher scores indicate better self-perceived health.


  4. General self-efficacy [ Time Frame: Between baseline and 12 months follow up ]

    Change in general self-efficacy score obtained by the General Self Efficacy Scale collected through a clinical registry of people with chronic back pain (SpineData).

    The General Self efficacy scale is a self-reported unidimensional measure of general sense of perceived self-efficacy designed for the general adult population and used in patients with chronic pain.

    The questionnaire comprises of 10 items (statements) with 4 response options. Responses are scored on a 4-point Likert-scale from 1 (not true at all) to 4 (exactly true).

    Responses of all 10 items are summarised to yield the final composite score with a range from 10 - 40 points.

    Higher scores express greater perceived self-efficacy.



Other Outcome Measures:
  1. Diagnosis [ Time Frame: At baseline ]
    ICD-10 diagnosis codes collected from nationwide registers

  2. Age [ Time Frame: At baseline ]
    Potential prognostic factor / confounder collected from nationwide registers

  3. Sex [ Time Frame: At baseline ]
    Potential prognostic factor / confounder collected from nationwide registers

  4. Height [ Time Frame: At baseline ]
    Potential prognostic factor / confounder collected through a clinical registry of people with chronic back pain (SpineData)

  5. Weight [ Time Frame: At baseline ]
    Potential prognostic factor / confounder collected through a clinical registry of people with chronic back pain (SpineData)

  6. Cohabitation status [ Time Frame: At baseline ]
    Potential prognostic factor / confounder collected from nationwide registers

  7. Income [ Time Frame: At baseline ]
    Potential prognostic factor / confounder collected from nationwide registers

  8. Socio-economic classification [ Time Frame: At baseline ]
    Potential prognostic factor / confounder collected from nationwide registers

  9. Work status [ Time Frame: At baseline ]
    Potential prognostic factor / confounder collected from nationwide registers

  10. Highest level of education completed [ Time Frame: At baseline ]
    Potential prognostic factor / confounder collected from nationwide registers

  11. Number of consultations in primary health care centers [ Time Frame: From baseline to 12 months follow up ]
    Potential prognostic factor / confounder collected from nationwide registers

  12. Number of hospital admissions [ Time Frame: From baseline to 12 months follow up ]
    Potential prognostic factor / confounder collected from nationwide registers

  13. Use of prescriptive analgesic medicine [ Time Frame: From baseline to 12 months follow up ]
    Potential prognostic factor / confounder collected from nationwide registers

  14. Hospital department [ Time Frame: From baseline to 12 months follow up ]
    Potential prognostic factor / confounder collected from nationwide registers

  15. Duration of symptoms [ Time Frame: At baseline ]
    Potential prognostic factor / confounder collected through a clinical registry of people with chronic back pain (SpineData)

  16. Low back pain intensity [ Time Frame: From baseline to 12 months follow up ]

    Change in Numerical Pain Rating Scale (NPRS) as Potential prognostic factor / confounder collected through a clinical registry of people with chronic back pain (SpineData).

    The Numeric Pain Rating Scale (NPRS) is an 11-point, unidimensional measure of pain intensity in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable).

    Lower scores indicate less pain.


  17. Leg pain intensity [ Time Frame: From baseline to 12 months follow up ]

    Change in Numerical Pain Rating Scale (NPRS) as potential prognostic factor / confounder collected through a clinical registry of people with chronic back pain (SpineData).

    The Numeric Pain Rating Scale (NPRS) is an 11-point, unidimensional measure of pain intensity in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable).

    Lower scores indicate less pain.


  18. Comorbidity [ Time Frame: From baseline to 12 months follow up ]

    Charlson comorbidity index as potential prognostic factor / confounder collected from nationwide registers.

    The Charlson Comorbidity Index is a method of categorising comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as a national patient registry.

    Each comorbidity category has an associated weight (from 1 to 6), based on the relative risk of 1-year mortality. The sum of all the weights results in a single comorbidity score for a patient.

    An index score of 0 indicates that no comorbidities were found.

    A higher index score indicates a higher risk of death within 1 year.


  19. Degree of central stenosis [ Time Frame: At baseline ]

    Potential prognostic factor / confounder collected from Magnetic Resonance Imaging (MRI) descriptions in hospital medical records.

    MRI graded compression is estimated using a classification ranging from mild to moderate or severe stenosis.

    Mild stenosis is defined as narrowing of one-third of the normal area or less, moderate stenosis as narrowing of between one- and two-thirds, and severe stenosis as narrowing of more than two-thirds of the area.




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Ages Eligible for Study:   61 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients >60 years, diagnosed with lumbar spinal stenosis and having first clinical contact at the Spine Center of Southern Denmark, Hospital Lillebaelt, Middelfart from January 1st - December 31st 2017 eligible for this study, will be identified in the National Patient Register. Follow-up time from the date of first clinical contact (baseline) is 6 and 12 months.
Criteria

Inclusion Criteria:

  1. >60 years.
  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:

-


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): NCT03548441


Contacts
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Contact: Helle A Brøgger, MSc +45 7266 2767 Helle.Algren.Brogger@rsyd.dk
Contact: Berit Schiøttz-Christensen, PhD +45 2155 2927 Berit.Schiottz-Christensen@rsyd.dk

Locations
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Denmark
Spine Centre of Souther Denmark Recruiting
Middelfart, Fyn, Denmark, 5500
Contact: Helle A Brøgger, PhD student    +45 7266 2767    Helle.Algren.Brogger@rsyd.dk   
Contact: Berit Schiøttz-Christensen, Professor    +45 2155 2927    Berit.Schiottz-Christensen@rsyd.dk   
Sponsors and Collaborators
Spine Centre of Southern Denmark
University of Southern Denmark
Parker Research Institute
Odense University Hospital
University College South Denmark
University of Aarhus
Defactum, Central Denmark Region
Investigators
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Principal Investigator: Helle A Brøgger, MSc 1) Spine Centre of Southern Denmark, 2) University of Southern Denmark, 3) The Parker Research Institute, 4) University College South Denmark
Study Director: Robin Christensen, PhD 1) The Parker Research Institute 2) Odense University Hospital
Study Director: Thomas Maribo, PhD 1) Aarhus University 2) DEFACTUM
Study Chair: Berit Schiøttz-Christensen, PhD 1) Spine Centre of Southern Denmark, 2) University of Southern Denmark

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Spine Centre of Southern Denmark
ClinicalTrials.gov Identifier: NCT03548441     History of Changes
Other Study ID Numbers: 17/30636
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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

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