NCT05794373

Brief Summary

A consistent theme in the modern-day healthcare system is the difficulty of transferring research knowledge into clinical practice. Recently, it has been pointed out that this is a barrier for providing care that is evidence-based which may partly explain the growing burden of low back pain. Low back pain, as all other musculoskeletal pain conditions is multidimensional where biomedical and psychological factors need to be accounted for, as well as the patient's social context. From the healthcare provider perspective, this requires skills that often goes beyond the basic training where clinicians need to be able to assess and manage the multiple domains in a patient-centered manner. In Denmark, people living with disabling low back pain can be referred to a municipality-based rehabilitation program. This study seeks to investigate whether providing physiotherapists an evidence-based educational course on the management of low back pain will change patient-related outcomes. Likewise, we will investigate potential barriers and facilitators for implementing the skills the physiotherapists acquire in clinical practice. If the project shows a favorable effect, it will allow for upscaling the intervention within and across municipalities. Moreover, a positive outcome may provide indications of what type of continuing education resources should be made available to help clinicians better manage complicated low back pain problems.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

2.1 years

First QC Date

February 3, 2023

Last Update Submit

August 12, 2024

Conditions

Keywords

Chronic low back painRehabilitationPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Disability

    Change in disability measured on the Roland Morris Disability Questionnaire between baseline and follow up. Questionnaire designed to capture disability in low back pain patients (0-24 where 0 = no loss of function and 24 = complete loss of function)

    At baseline and 3 months after starting rehabilitation

Secondary Outcomes (4)

  • Pain intensity

    At baseline and 3 months after starting rehabilitation

  • Emotional and cognitive functioning

    At baseline and 3 months after starting rehabilitation

  • Sick leave from work

    At baseline and 3 months after starting rehabilitation

  • Patient Assessment of Transitions in Healthcare

    3 months after starting rehabilitation

Other Outcomes (2)

  • Checklist to determine the competency of clinicians

    Up to 24 weeks after the project period has ended

  • Barriers and facilitators for implementing new knowledge in clinical practice - qualitative interview

    Up to 24 weeks after the project period has ended

Study Arms (2)

Pre-Education group

Patients in this group undergo rehabilitation for back pain in a municipality setting with physiotherapists before the physiotherapists have participated in an educational intervention

Procedure: Standard physiotherapy for low back pain in a municipality setting

Post-Education group

Patients in this group undergo rehabilitation for back pain in a municipality setting with physiotherapists after they have participated in an educational intervention

Procedure: Standard physiotherapy for low back pain in a municipality setting

Interventions

Patients (N=100) referred to a municipality-based rehabilitation for low back pain are included. The physiotherapists choose the rehabilitation strategy based on what they consider relevant for the patients. After the first 100 patients have been discharged from municipality care, the physiotherapists will participate in an educational intervention (12 sessions) focusing on the management of low back pain within a multidimensional framework. In the educational intervention, the participants will learn how to identify the presence of unhelpful thoughts and emotions and how to address these as part of the intervention. The course will thus be a mix of theoretical and practical teaching, including case supervision and feedback. Following the educational intervention, an additional 100 patients referred to the rehabilitation program will be included. The intervention is aimed at the physiotherapists where the patients will receive the best available care, before or after the intervention.

Post-Education groupPre-Education group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Physiotherapists working in a municpality setting (N=25) in the region of southern Denmark. Minimum one year clinical experience in working with spine-related disorders

You may qualify if:

  • referred to municipality care from the Spine Clinic of Southern Denmark
  • Between 18-65 years
  • Speaks and comprehends Danish
  • A score over 40 on the Orebro Musculoskeletal Pain Questionnaire
  • Low back pain as dominating cause for referral

You may not qualify if:

  • A current diagnosis of psychiatric illness that precludes participation in rehabilitation
  • A neurologic disorder or other disease that may affect the ability to participate in a municipality based rehabilitation program
  • A neurological deficits related with radiographically confirmed lumbar spinal stenosis or radicular pain correlating with the clinical presentation
  • Recent (within 6 months) history of a stabilizing operation of the low back

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Center of Southern Denmark

Middelfart, 5500, Denmark

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thorvaldur S Palsson, PhD

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research,

Study Record Dates

First Submitted

February 3, 2023

First Posted

April 3, 2023

Study Start

March 1, 2023

Primary Completion

April 1, 2025

Study Completion

December 1, 2025

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations