University of Oulu

Simula, A.S., Jenkins, H.J., Hancock, M.J. et al. Patient education booklet to support evidence-based low back pain care in primary care – a cluster randomized controlled trial. BMC Fam Pract 22, 178 (2021).

Patient education booklet to support evidence-based low back pain care in primary care : a cluster randomized controlled trial

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Author: Simula, Anna S.1,2; Jenkins, Hazel J.3,4; Hancock, Mark J.3;
Organizations: 1Medical Research Center Oulu, Oulu University Hospital and University of Oulu, P.O. Box 8000, 90014, Oulu, Finland
2Department of General Medicine, the South Savo Social and Health Care Authority, Porrassalmenkatu 35-37, 50100, Mikkeli, Finland
3Department of Health Professions, Faculty of Medicine, Health, and Human Sciences, Macquarie University, Balaclava Road, North Ryde, NSW, 2109, Australia
4Department of Chiropractic, Faculty of Medicine, Health, and Human Sciences, Macquarie University, Balaclava Road, North Ryde, NSW, 2109, Australia
5Finnish Institute for Health and Welfare, P.O. Box 30, 00271, Helsinki, Finland
6Faculty of Social Sciences (Health Sciences), Tampere University, Arvo Ylpön katu 34, 33014, Tampere, Finland
7Finnish Institute of Occupational Health, Aapistie 1, 90220, Oulu, Finland
8Rehabilitation Services of South Karelia Social and Health Care District, Lappeenranta, Finland
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 1.3 MB)
Persistent link:
Language: English
Published: Springer Nature, 2021
Publish Date: 2021-10-28


Background: Inappropriate imaging and low-value care for low back pain (LBP) are common. A new patient-education booklet was created to overcome identified barriers to the delivery of recommended care, including the use of inappropriate imaging. Our aim was to assess the effectiveness of this booklet as part of primary care for LBP patients in comparison to usual care.

Methods: A cluster-randomized trial was performed. The intervention involved providing practitioners with the new patient-education booklet and a 30-min training session on its use. The booklet was provided during the clinical consult to all consenting LBP patients in the intervention group. Primary outcomes were the proportion of patients presenting with LBP who underwent imaging examinations during the first three months of follow-up and PROMIS PF-20 (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form) change between baseline and three-month follow-up. Secondary outcomes, including sick leave and imaging examinations at 12 months, were investigated. Logistic regression using GEE-estimation was used for dichotomous outcomes, Poisson regression using GEE-estimation for count outcomes, and linear mixed models for continuous outcomes.

Results: Using the patient education booklet appeared to substantially reduce the proportion of LBP patients who underwent an imaging examination at three months, but the result was not statistically significant (OR 0.57, 95% confidence interval (Cl) 0.27 to 1.22). At 12 months, the effect was slightly larger and statistically significant (OR 0.50, 95%Cl 0.30 to 0.83, p = 0.008). No difference was observed in the PROMIS PF-20 T-score change between baseline and 3 months or 12 months (p = 0.365 and p = 0.923, respectively). The number of sick leave days in the intervention group was less than that in the control group at 3 months (RR 0.47, 95%Cl 0.26 to 0.83, p = 0.010) and at 12 months (RR 0.36, 95%Cl 0.18 to 0.72, p = 0.004).

Conclusions: The booklet appeared to be effective in reducing the proportion of LBP patients who underwent imaging examinations over 12 months. The intervention had no discernible effect on the PROMIS PF20 T-score change. The number of sick leave days was substantially lower in the intervention group.

Trial registration: ISRCTN, ISRCTN14389368, Registered 4 April 2019—Retrospectively registered.

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Series: BMC family practice
ISSN: 1471-2296
ISSN-E: 1471-2296
ISSN-L: 1471-2296
Volume: 22
Issue: 1
Article number: 178
DOI: 10.1186/s12875-021-01529-2
Type of Publication: A1 Journal article – refereed
Field of Science: 3121 General medicine, internal medicine and other clinical medicine
3142 Public health care science, environmental and occupational health
Funding: Short-term Doctoral Student Positions 2018–2021 (6 month each year) are funded by the University of Oulu Health and Biosciences Doctoral Program (ASS). Funding for the research assistant in Mikkeli was granted by ESSOTE (South Savo social and health care authority). State Research Funding was granted for research assistant costs in Rovaniemi. ASS has received grants from the Finnish Cultural Foundation (ASS).
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