An interventional study of Education and Exercise in Low Back Pain, sponsored by Spine Centre of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Spine Centre of Southern Denmark · Not applicable, Interventional, and Treatment
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:
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:
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Spine Centre of Southern Denmark is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A pragmatic team-based management approach is individualized for each patient.
Behavioral: Education · Behavioral: Exercise
The team will educate the patient about low back pain and how this can be self-managed.
Also known as: Long-term team-based support
The team will advice the patient to conduct relevant exercises and to stay physical active.
Disability
The Oswestry disability index
Time frame: Changes in mean values from baseline to 3 months
Plan to share: No — We have no plans of sharing the individual participant data, as there is no available data for secondary analyses.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Spine Centre of Southern Denmark