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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Surgery; Other: Non-surgical management

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Helle A Brøgger, MSc; Phone Number: +45 7266 2767; Email: Helle.Algren.Brogger@rsyd.dk
• Study Contact Backup: Name: Berit Schiøttz-Christensen, PhD; Phone Number: +45 2155 2927; Email: Berit.Schiottz-Christensen@rsyd.dk

Study Locations

• Denmark
  • Fyn
    • Middelfart, Fyn, Denmark, 5500
      • Recruiting
      • Spine Centre of Souther Denmark
      • Contact: Helle A Brøgger, PhD student; Phone Number: +45 7266 2767; Email: Helle.Algren.Brogger@rsyd.dk
      • Contact: Berit Schiøttz-Christensen, Professor; Phone Number: +45 2155 2927; Email: Berit.Schiottz-Christensen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function	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.	Between baseline and 12 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom severity	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.	Between baseline and 12 months follow up
Pain related physical function	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.	Between baseline and 12 months follow up
Health related quality of life	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.	Between baseline and 12 months follow up
General self-efficacy	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.	Between baseline and 12 months follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis	ICD-10 diagnosis codes collected from nationwide registers	At baseline
Age	Potential prognostic factor / confounder collected from nationwide registers	At baseline
Sex	Potential prognostic factor / confounder collected from nationwide registers	At baseline
Height	Potential prognostic factor / confounder collected through a clinical registry of people with chronic back pain (SpineData)	At baseline
Weight	Potential prognostic factor / confounder collected through a clinical registry of people with chronic back pain (SpineData)	At baseline
Cohabitation status	Potential prognostic factor / confounder collected from nationwide registers	At baseline
Income	Potential prognostic factor / confounder collected from nationwide registers	At baseline
Socio-economic classification	Potential prognostic factor / confounder collected from nationwide registers	At baseline
Work status	Potential prognostic factor / confounder collected from nationwide registers	At baseline
Highest level of education completed	Potential prognostic factor / confounder collected from nationwide registers	At baseline
Number of consultations in primary health care centers	Potential prognostic factor / confounder collected from nationwide registers	From baseline to 12 months follow up
Number of hospital admissions	Potential prognostic factor / confounder collected from nationwide registers	From baseline to 12 months follow up
Use of prescriptive analgesic medicine	Potential prognostic factor / confounder collected from nationwide registers	From baseline to 12 months follow up
Hospital department	Potential prognostic factor / confounder collected from nationwide registers	From baseline to 12 months follow up
Duration of symptoms	Potential prognostic factor / confounder collected through a clinical registry of people with chronic back pain (SpineData)	At baseline
Low back pain intensity	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.	From baseline to 12 months follow up
Leg pain intensity	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.	From baseline to 12 months follow up
Comorbidity	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.	From baseline to 12 months follow up
Degree of central stenosis	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.	At baseline

Collaborators and Investigators

• Sponsor: Spine Centre of Southern Denmark
• Collaborators: Odense University Hospital; University of Aarhus; Parker Research Institute; University of Southern Denmark; Defactum, Central Denmark Region; University College South Denmark
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 17/30636

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No