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

NCT03548441 | Unknown DMC

• 1 other identifier: 17/30636
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Symptom severity

  Between baseline and 12 months follow up

• Pain related physical function

  Between baseline and 12 months follow up

• Health related quality of life

  Between baseline and 12 months follow up

• General self-efficacy

  Between baseline and 12 months follow up

Other Outcomes (19)

• Diagnosis

  At baseline

• Age

  At baseline

• Sex

  At baseline

Study Arms (2)

Surgery

Exposed

Procedure: Surgery

Non-surgical management

Non-exposed

Other: Non-surgical management

Interventions

Surgery PROCEDURE

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.

Surgery

Non-surgical management OTHER

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.

Non-surgical management

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \>60 years.
• ICD-10 diagnosis of degenerative lumbar spinal stenosis registered in the nationwide patient registry between January 1st - December 31st 2017.
• Included in the SpineData registry.
• Give consent to use patient-reported data for research purposes

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead
• University of Southern Denmark: collaborator
• Parker Research Institute: collaborator
• Odense University Hospital: collaborator
• University College South Denmark: collaborator
• University of Aarhus: collaborator
• Defactum, Central Denmark Region: collaborator

Study Sites (1)

Spine Centre of Souther Denmark

Middelfart, Fyn, 5500, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 30573489 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Robin Christensen, PhD

  1) The Parker Research Institute 2) Odense University Hospital

  STUDY DIRECTOR

• Thomas Maribo, PhD

  1) Aarhus University 2) DEFACTUM

  STUDY DIRECTOR

• Berit Schiøttz-Christensen, PhD

  1) Spine Centre of Southern Denmark, 2) University of Southern Denmark

  STUDY CHAIR

Central Study Contacts

Helle A Brøgger, MSc

CONTACT

+45 7266 2767; Helle.Algren.Brogger@rsyd.dk

Berit Schiøttz-Christensen, PhD

CONTACT

+45 2155 2927; Berit.Schiottz-Christensen@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: June 7, 2018
• Study Start: January 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

DK (1)