Clinical trial NCT03548441: Comparative Effectiveness and Prognostic Factors of Surgical and Non-surgical Management of Lumbar Spinal Stenosis
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Spine Centre of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Parker Research Institute
name: Odense University Hospital
name: University College South Denmark
name: University of Aarhus
name: Defactum, Central Denmark Region
First posted: 2018-06-07
Enrollment: 600
Sex: ALL
Minimum age (years): 61
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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:

-

Primary outcomes:
measure: Physical function
timeFrame: Between baseline and 12 months follow up
Secondary outcomes:
measure: Symptom severity
timeFrame: Between baseline and 12 months follow up
measure: Pain related physical function
timeFrame: Between baseline and 12 months follow up
measure: Health related quality of life
timeFrame: Between baseline and 12 months follow up
measure: General self-efficacy
timeFrame: Between baseline and 12 months follow up
Other outcomes:
measure: Diagnosis
timeFrame: At baseline
measure: Age
timeFrame: At baseline
measure: Sex
timeFrame: At baseline
measure: Height
timeFrame: At baseline
measure: Weight
timeFrame: At baseline
measure: Cohabitation status
timeFrame: At baseline
measure: Income
timeFrame: At baseline
measure: Socio-economic classification
timeFrame: At baseline
measure: Work status
timeFrame: At baseline
measure: Highest level of education completed
timeFrame: At baseline
measure: Number of consultations in primary health care centers
timeFrame: From baseline to 12 months follow up
measure: Number of hospital admissions
timeFrame: From baseline to 12 months follow up
measure: Use of prescriptive analgesic medicine
timeFrame: From baseline to 12 months follow up
measure: Hospital department
timeFrame: From baseline to 12 months follow up
measure: Duration of symptoms
timeFrame: At baseline
measure: Low back pain intensity
timeFrame: From baseline to 12 months follow up
measure: Leg pain intensity
timeFrame: From baseline to 12 months follow up
measure: Comorbidity
timeFrame: From baseline to 12 months follow up
measure: Degree of central stenosis
timeFrame: At baseline
Locations:
city: Middelfart
country: Denmark
facility: Spine Centre of Souther Denmark
state: Fyn
Study officials:
affiliation: 1) Spine Centre of Southern Denmark, 2) University of Southern Denmark, 3) The Parker Research Institute, 4) University College South Denmark
name: Helle A Brøgger, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: 1) The Parker Research Institute 2) Odense University Hospital
name: Robin Christensen, PhD
role: STUDY_DIRECTOR
affiliation: 1) Aarhus University 2) DEFACTUM
name: Thomas Maribo, PhD
role: STUDY_DIRECTOR
affiliation: 1) Spine Centre of Southern Denmark, 2) University of Southern Denmark
name: Berit Schiøttz-Christensen, PhD
role: STUDY_CHAIR
References:
citation: 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.