Clinical Trial Summary
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 is currently observed.
The investigators 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
The investigators will develop and test 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, focusing on conducting a
large randomized controlled trial as the next phase.
This feasibility trial will be completed in a secondary care settings, where relevant
patients with poor management skills and insufficient effects of usual (primary) care
management can be identified.
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 by assessing:
- Changes in relevant outcomes
- Utilization of Primary care
- Patients and clinicians experience with the intervention
- Practical challenges of the setting
The management strategy development follows the principles provided by the Medical Research
Council for developing complex interventions.
Development of the framework
Step 1: Framework setup
The investigators constructed a basic framework for the intervention by reviewing relevant
systematic reviews and clinical guidelines. The research group determined the initial
management intervention. Afterward, the investigators conducted a small survey on 191
participants (11% of the total sample of patients between February and May 2021), about their
interest in participating. The majority would find such an approach of interest (147(77%)).
In parallel, the investigators conducted short semi-structured interviews concerning the
intervention with a convenient sample of 20 patients. Seventeen provided usable data.
Step 2 - Development
Using the participants' information, the investigators re-framed the management strategy.
Subsequent semi-structured focus-group interviews with a clinical panel for further
modifications before testing was conducted.
Step 3 - Feasibility
The multidisciplinary team for the feasibility trial consists of two coordinators
(chiropractors), two therapists (physical therapists), one medical doctor, and one nurse.
The feasibility trial aims to identify and develop the appropriate framework by:
I) Investigating the patients' experiences of the current management strategy II) Ensuring
satisfactory work-relations between clinicians III) Determining the primary outcome IV)
Mapping the multiple interacting components of the management strategy V) Investigating how
to measure parallel use of primary care and how this could be applied in the trial evaluation
VI) Estimating the workload (number of hours) of the clinicians VII) Quantifying any
out-of-protocol behaviors by clinicians and patients alike VIII) Quantifying the different
aspects of the intervention using the clinical records
The feasibility trial will include 25 LBP patients from the Spine Centre willing to
participate in a limited three-month follow-up.
The intervention procedure is:
1) A team meeting will be held each morning where the coordinator and the feasibility team
will go through the patients. This will start the initial sparring process to ensure a
structured and unchanging message for the patient.
The coordinator will first assess each patient face-to-face according to ICD-10 principles
and enroll eligible patients in the trial. Afterward, the therapist will evaluate the
patient's current functional status and management strategy. During the three months,
patients will have multiple encounters with the coordinator, the therapist, and the nurse, if
needed. The therapist will provide further interventions (e.g., exercise and
cognitive/behavioral therapy) to encourage self-management.
The investigators will assess the following outcomes at three months: Disability (primary),
pain, self-efficacy, quality of life, LBP trajectory, workability, and work retention.
