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Long-term Multidisciplinary Team-based Management of Back Pain (TeamBack)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Education
Exercise
Sponsored by
Spine Centre of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Spine Centre of Southern Denmark

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multidisciplinary

Arm Description

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

Outcomes

Primary Outcome Measures

Disability
The Oswestry disability index

Secondary Outcome Measures

Full Information

First Posted
October 13, 2021
Last Updated
April 22, 2022
Sponsor
Spine Centre of Southern Denmark
Collaborators
Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05115227
Brief Title
Long-term Multidisciplinary Team-based Management of Back Pain
Acronym
TeamBack
Official Title
Long-term Multidisciplinary Team-based Management of Back Pain: Development and Feasibility (TeamBack Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
April 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spine Centre of Southern Denmark
Collaborators
Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidisciplinary
Arm Type
Experimental
Arm Description
A pragmatic team-based management approach is individualized for each patient.
Intervention Type
Behavioral
Intervention Name(s)
Education
Other Intervention Name(s)
Long-term team-based support
Intervention Description
The team will educate the patient about low back pain and how this can be self-managed.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
The team will advice the patient to conduct relevant exercises and to stay physical active.
Primary Outcome Measure Information:
Title
Disability
Description
The Oswestry disability index
Time Frame
Changes in mean values from baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to speak Danish Disability score > 40% Duration of current episode > 3 months Exclusion Criteria: Surgical candidate due to acute radiculopathy Malignant or inflammatory back pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casper G Nim, PhD
Organizational Affiliation
Spine Center of Southern Denmark, University Hospital of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spine Centre of Southern Denmark
City
Middelfart
ZIP/Postal Code
5500
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have no plans of sharing the individual participant data, as there is no available data for secondary analyses.

Learn more about this trial

Long-term Multidisciplinary Team-based Management of Back Pain

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