Article Text
PDF
Abstract
Introduction Lumbar spinal stenosis is a common cause of low back and leg pain in the elderly and affects both physical activity and quality of life. First-line treatments are non-surgical options but if unsuccessful, surgery is advocated. The literature is not clear as to the outcome of surgery compared with non-surgical treatment, and the optimal time for surgery is not explicit. This observational study is designed to investigate the course of treatment, compare effectiveness of surgical and non-surgical management in patients with lumbar spinal stenosis and identify prognostic factors for outcome in the context of current clinical practice.
Materials and analysis 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. Outcomes are assessed at baseline and 6 and 12 months. Outcomes at 12 months will be compared for patients who undergo surgery for lumbar spinal stenosis and patients managed non-surgically, using different analytical approaches. Prespecified prognostic factors of interest at baseline include treatment allocation, back and leg pain intensity, comorbidity, duration of symptoms, pretreatment function, self-rated health, income, general self-efficacy and MRI-graded severity 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 (18/22336). All participants provide consent. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences according to the Strengthening the Reporting of Observational Studies in Epidemiology and Prognosis Research Strategy statements. Potential sources of bias will be addressed using Risk of Bias in Non-randomised Studies of Interventions.
Trial registration number NCT03548441; Pre-results.
- lumbar spinal stenosis
- surgery
- non-surgical management
- comparative effectiveness
- prognostic factors
- patient reported outcome
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Footnotes
Patient consent for publication Not required.
Contributors HAB and BS-C conceived the study. All authors participated in the study design and the preliminary analysis plan. HAB constructed the first draft of the manuscript. All authors contributed to writing the manuscript. TM contributed substantially to writing the section on outcome measures. RC contributed substantially to the power analysis calculations and in writing the statistical analyses section. BS-C contributed substantially to writing the introduction and the section on data collection. All authors participated in critical scrutinising and revision of the manuscript and approved the final version.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests TM and BS-C have nothing to disclose. HAB reports unrestricted grants from the University of Southern Denmark, the Region of Southern Denmark, the University College of Southern Denmark and non-financial support from Spine Centre of Southern Denmark, during the conduct of the study. RC reports non-financial support from Board membership, grants from Consultancy (AbbVie, Amgen, Axellus A/S, Bristol-Myers Squibb, Cambridge Weight Plan, Celgene, Eli Lilly, Hospira, MSD, Norpharma, Novartis, Orkla Health, Pfizer, Roche, Sobi, Takeda), personal fees from Employment (Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark), non-financial support from Expert testimony, grants from grants/grants pending (Axellus A/S, AbbVie, Cambridge Weight Plan, Janssen, MSD, Mundipharma, Novartis and Roche), grants from payment for lectures including service on speakers bureaus (Abbott, Amgen, Axellus, Bayer HealthCare Pharmaceuticals, Biogen Idec, Bristol-Myers Squibb, Cambridge Weight Plan, Ipsen, Janssen, Laboratoires Expanscience, MSD, Mundipharma, Norpharma, Novartis, Pfizer, Roche, Rottapharm-Madaus, Sobi and Wyeth), grants from payment for manuscript preparation (Axellus, Bristol-Myers Squibb and Cambridge Weight Plan, Aleris-Hamlet (via Norpharma)), non-financial support from Patents (planned, pending or issued), non-financial support from Royalties, grants from payment for development of educational presentations (Bristol-Myers Squibb, MSD, Pfizer), non-financial support from stock/stock options, grants from travel/accommodations/meeting expenses unrelated to activities listed (Abbott, AbbVie, Axellus, Biogen, Bristol-Myers Squibb, Cambridge Weight Plan, Celgene, Laboratoires Expanscience, Norpharma, Novartis, Pfizer, Roche, Rottapharm-Madaus and Wyeth), non-financial support from Other (err on the side of full disclosure), outside the submitted work and is involved in many healthcare initiatives and research that could benefit from wide uptake of this publication (including Cochrane, OMERACT, IDEOM, RADS and the GRADE Working Group). Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation; The Oak Foundation is a group of philanthropic organisations that, since its establishment in 1983, has given grants to not-for-profit organisations around the world.
Ethics approval A review by the Regional Committees on Health Research Ethics for Southern Denmark concluded that ethical approval was not required for this study according to the Danish Act on Research Ethics Review of Health Research Projects (S-20172000–200).
Provenance and peer review Not commissioned; externally peer reviewed.