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Referrals for uncomplicated lower back pain: a cluster parallel randomised trial of patient-centred communication to improve the management of acute back pain in primary care. A study protocol
  1. Angela Schedlbauer1,
  2. Larissa Burggraf1,
  3. Susann Hueber1,
  4. Irini-Alexia Terzakis-Snyder2,
  5. Thomas Kühlein1,
  6. Marco Roos1
  1. 1Insitute of General Practice, Friedrich-Alexander-Universität Erlangen Nürnberg (FAU), Universitätsstraße 29, Erlangen, Germany
  2. 2Institute of Clinical Psychology, Friedrich-Alexander-Universität Erlangen Nürnberg (FAU), Nägelsbachstrasse 25a, Erlangen, Germany
  1. Correspondence to Dr Angela Schedlbauer; angela.schedlbauer{at}


Introduction Low back pain (LBP) is one of the most frequent encounters in General Practice. Investigation and referral remain common despite the self-limiting character of episodes that are not largely attributable to specific underlying injuries. Identifying patients’ ideas, concerns and expectations (ICE) is a well-established element within consultation skills training and has been shown to improve prescribing. It can be a powerful communication tool setting the base for transferring and adjusting adequate clinical information. This study aims to evaluate whether ICE can decrease unnecessary medicine in the management of acute LBP in primary care.

Methods and analysis Research question: Does ICE training intervention have an effect on doctors’ referrals of patients suffering from acute LBP? Population: Recruitment to this parallel cluster randomised trial will take place among general practitioners belonging to four independent practice networks in Northern Bavaria/Germany. Intervention: At baseline, 24 out of 48 doctors will be randomly assigned to take part in a 1-day training session covering theoretical background and clinical implementation of patient-centred communication by stimulating ICE. They will also be given access to a web-based supporting tool for reflective practice on their communication skills. Comparison: GPs in the control group will continue consultations as usual. Outcome: Outcome measures are referrals to diagnostic imaging, physiotherapy and specialists obtained from routine practice data, compared between intervention and control group. Time: Referrals of patients consulting their doctors for documented LBP will be monitored up to 3 months after the ICE training intervention.

Ethics and dissemination Ethical approval for the study was obtained by the Ethics Committee of the University Erlangen-Nuremberg (296_17B). Results will be disseminated by conference presentations and journal publications.

Trial registration number The trial is registered in (NCT03711071).

  • primary care
  • communication
  • doctor–patient relationship
  • consultation
  • information exchange
  • shared decision-making
  • medical education
  • low back pain
  • diagnosis
  • over investigation

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  • Contributors AS: Study design, methods, writing original draft. LB: Project management, theoretical development, methodological adjustment. SH: Study design, methods, review and editing. I-AT-S: Project partner, concept and development of interactive online tool for reflective practice. MR: Study design, methods, supervision, review and editing. TK: Study design, supervision, review and editing.

  • Funding This study was funded by the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF), grant number 01GY1605.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethic approval was received by the institutional review board of Erlangen University ethic commission (Ethikkommission der Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany; Ethics Committee of the University Erlangen-Nuremberg, Erlangen/Germany: Number 296_17 B).

  • Provenance and peer review Not commissioned; externally peer reviewed.