OPEN Research Support

Casper Glissmann Nim
Spine Centre of Southern Denmark, Hospital of Lillebaelt

Projekt styring
Projekt status    Closed
Data indsamlingsdatoer
Start 01.11.2021  
Slut 01.09.2025  

The SAFE trial: long-term supportive multidisciplinary team-based management evaluation of a proof-of-concept randomized controlled trial of secondary care low back pain patients

Short summary

This project will develop, test, and evaluate a long-term supportive multidisciplinary team-based management in the treatment of patients with long-term and highly disabling low back pain seen at a secondary-care spine center. The primary goal of the intervention is to enhance self-management strategies and thereby improve daily function.


Over the last 25 years, the burden of back pain has increased by 43% despite the prevalence remaining constant. As a result, low back pain (LBP) has become the leading cause of years lived with disability. This indicates that the management of LBP on the grander societal scale seems counterproductive. There is, thus, a need to re-evaluate our approach to managing LBP.

A structural barrier is that the current health care system is set up to treat LBP as a discrete episode that needs to be cured, i.e., in a manner similar to treatment of bacterial infections: Intensive curative treatment. In reality, LBP is more akin to diabetes that has to be co-managed in the long term. Therefore, in recent years several clinical guidelines have been published, which recommend a management approach to LBP rather than a curative approach.

However, such long-term approaches are challenging to implement within the current care system, which rewards clinicians for attempting to quick-fix a long-term condition. This results in increased inappropriate imaging, opioid prescriptions, surgery, and visits/rehabilitation in secondary care, leading to higher societal costs and the continuing increase of LBP-related disability that we currently observe.

We argue that LBP management can be optimized by providing patients with self-management strategies supported by a multidisciplinary team, and providing simple, safe, and low-cost interventions that adhere to clinical guidelines. This has the potential to change patient behaviors and facilitate empowerment to self-manage LBP leading to lower societal costs of LBP.

Research objectives

We will develop, test, and evaluate a long-term supportive multidisciplinary team-based management strategy with a specific focus on communicating a structured and unchanging message about individualized diagnosis, treatment, and prognosis.

To evaluate the clinical effect of such a management strategy, we will conduct a randomized trial as a proof-of-concept. The trial will be completed in a secondary care settings, where we can identify relevant patients with poor management skills and insufficient effects of usual (primary) care management. We can test the efficacy and cost-effectiveness of our management strategy by comparing it to usual-care in a controlled environment with experienced clinicians.

The specific objectives are:

(I) To develop a long-term supportive multidisciplinary team-based management strategy for secondary-care low back pain patients

(II) To test the feasibility

(III) To assess whether long-term supportive multidisciplinary team-based management strategy is superior to usual care in secondary care setting for low back pain patients.

We will examine between-group differences in:

a) Essential patient-reported outcomes (long term)

b) Cost-effectiveness by reducing inappropriate and unhelpful interventions and facilitating work return/retention.

(IV) Provide a preliminary clinical pathway/framework for implementation in primary care if our hypothesis is supported.

Description of the cohort

Patients diagnosed with non-specific or degenerative LBP (excluding malignant, infectious, multi-traumatic, or inflammatory LBP) from the Spine Centre of Southern Denmark.

Data and biological material

Patient-reported questionnaires include information about sociodemographic factors, pain, activity limitation, work, and psychological factors.

Participants are surveyed at baseline, 3, 6, 12, 18, and 24 months. In addition they are followed by SMS-tracking (pain and sickleave) at each week in the first 12 months

Collaborating researchers and departments

Spine Centre of Southern Denmark

  • Søren O'Neill

Department of Sports Science and Biomechanics, University of Southern Denmark

  • Alice Kongsted
  • Bart Koes