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

Lumbar Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03548441
• Other study ID #: 17/30636
• Status: Recruiting
• Start date: January 2017
• Est. completion date: September 2020

Study information

• Verified date: October 2018
• Source: Spine Centre of Southern Denmark
• Contact: Helle A Brøgger, MSc
• Phone: +45 7266 2767
• Email: Helle.Algren.Brogger[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 61 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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.

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.

Locations

Country	Name	City	State
Denmark	Spine Centre of Souther Denmark	Middelfart	Fyn

Sponsors (7)

Lead Sponsor	Collaborator
Spine Centre of Southern Denmark	Defactum, Central Denmark Region, Odense University Hospital, Parker Research Institute, University College South Denmark, University of Aarhus, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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