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CompletedNCT05115227TeamBackUpdated Apr 25, 2022

Long-term Multidisciplinary Team-based Management of Back Pain

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

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Low Back Pain
03

In context

Back Pain

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Able to speak Danish
  • Disability score > 40%
  • Duration of current episode > 3 months

Exclusion criteria

Exclusion Criteria:

  • Surgical candidate due to acute radiculopathy
  • Malignant or inflammatory back pain
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Multidisciplinary

    A pragmatic team-based management approach is individualized for each patient.

    Behavioral: Education · Behavioral: Exercise

Interventions

  • BehavioralEducation

    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

  • BehavioralExercise

    The team will advice the patient to conduct relevant exercises and to stay physical active.

06

What researchers measure

Primary outcomes

  1. Disability

    The Oswestry disability index

    Time frame: Changes in mean values from baseline to 3 months

07

Study locations

1 site
  • Spine Centre of Southern Denmark
    Middelfart, 5500, Denmark
08

References and documents

Individual participant data

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05115227
Lead sponsor
Spine Centre of Southern Denmark
Collaborators
Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
Responsible party
Sponsor
First posted
Nov 10, 2021
Start date
Nov 10, 2021
Primary completion
Apr 20, 2022
Completion
Apr 20, 2022
Last update
Apr 25, 2022

Study contacts

Casper G Nim, PhD
principal investigator · Spine Center of Southern Denmark, University Hospital of Southern Denmark

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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