1. The document describes the development and piloting of two new rehabilitation programs for patients with chronic low back pain based on a biopsychosocial framework. 2. A multidisciplinary team developed the programs by identifying gaps in integrating learning into patients' environments and personal contexts, and describing the clinical activities. 3. The programs were piloted to refine procedures, define inclusion criteria, and estimate a sample size of 160 patients for evaluating the programs' effectiveness in reducing disability compared to usual care in a randomized controlled trial.

1. Development, test and systematic description of two complex
interventions for patients with chronic low back pain
Anne Mette Schmidt 1,2,
Helle Terkildsen Maindal 3,4,
Trine Bay Laurberg1,5
, Berit Schiøttz-Christensen 6,7
, Charlotte Ibsen 2,6
, Kirstine Bak Gulstad 1
, Thomas Maribo 2,8
1
Sano, Egernvej 5, Højbjerg, Denmark, 2
DEFACTUM, Central Denmark Region, Aarhus C, Denmark , 3
Department of Public Health, Section for Health Promotion and Health Services, Aarhus University, Aarhus C, Denmark,
4
Steno Diabetes Center Copenhagen, The Health Promotion Centre, Capital Region, Gentofte, Denmark, 5
Department of Rheumatology, Aarhus University Hospital, Aarhus C, Denmark
6
Spine Centre of Southern Denmark, Hospital Lillebælt, Middelfart, Denmark,
7
Institute for Regional Health Research, University of Southern Denmark, Middelfart, Denmark, 8
Department of Public Health, Section for Clinical Social Medicine and Rehabilitation, Aarhus University, Aarhus C, Denmark
Introduction
Despite a large body of literature on multidisciplinary
biopsychosocial rehabilitation and chronic low back pain,
knowledge is lacking regarding how to integrate learning
into the patient’s own environment and in the context of
personal resources.
Purpose
To develop, test and systematically describe a new
multi-disciplinary rehabilitation programme before the
evaluation.
Method
Medical Research Council’s guideline on complex interventions (1)
was used as a framework to describe the development and piloting
(Fig. 1). Quantitative and qualitative methods were used, and
patients, a multidisciplinary team (physiotherapists, occupational
therapists, nurses and a rheumatologist) and decision-makers were
continuously involved.
Results
In the development:
1. A lack of studies on how to integrate learning into the patient’s own
environment and in the context of personal resources was identified.
2. The International Classification of Functioning, Disability and Health
(ICF) was identified as an appropriate biopsychosocial framework.
3. The aim of the full-scale study will be to assess if the new
rehabilitation programme is more effective in reducing disability after
6 months, than the usual rehabilitation programme (Fig. 2). The TIDieR
checklist (2) was used to systematically describe the clinical activities
delivered by the multidisciplinary team.
In the piloting:
1. Administrative procedures were fine-tuned.
2. Inclusion criteria were defined.
3. A total sample size of 160 patients was estimated.
Figure 2. The Usual Rehabilitation Programme and the New Rehabilitation Programme.
Conclusion
The new rehabilitation programme is ready for
evaluation in a full-scale randomised controlled clinical
trial (the Sano study) comparing two parallel groups.
References
1. The Medical Research Council. Developing and evaluating complex interventions:
new guidance. [cited 2017 June 09]; Available at: http://www.mrc.ac.uk/documents/
pdf/complex-interventions-guidance/.
2. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better
reporting of interventions: template for intervention description and replication
(TIDieR) checklist and guide. BMJ. 2014;348Acknowledgements
The Central Denmark Region Committees on Biomedical and Research Ethics
approved the study (no. 1-10-72-117-16). Helle Algren Brøgger, Gorm Høi
Jensen, patients and providers are thanked for their contributions. Aarhus
University, The Danish Rheumatism Association and Sano are thanked for funding.
Contact details
Anne Mette Schmidt - e-mail: aschmidt@sanocenter.dk
Figure 1. The four-stage model with associated activities following a non-linear dynamic
iterative process. The model is inspired by the Medical Research Council.