Education of Municipality-based Physiotherapists in Managing Disabling Low Back Pain - an Observational Study

NCT ID: NCT05794373

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

Schedule of procedures and assessments

1. All participating physiotherapists will recruit eligible patients (N=100) who are asked to fill out project-specific questionnaires (see procedures) at the start and at the end of the rehabilitation program.

2. The participating physiotherapists will undergo a 13-day educational intervention (see description below under intervention) focusing on management of low back pain within an individualized multidimensional framework.

3. Point 1 is repeated on an additional 100 patients who undergo rehabilitation after the physiotherapists have completed the course

4. Participating physiotherapists will be evaluated on the background of a competency checklist which is scored by clinical supervisors connected to the study. The checklist will be scored after watching a video recording of a patient consultation performed by the physiotherapist in focus. The checklist covers 6 domains: Subjective and objective assessment, cognitive-functional therapy intervention, style of communication, patient's unhelpful pain behavior, and an overall assessment

5. Physiotherapists who demonstrate high and low competency (as determined by the evaluation of competency, point 4) are invited to participate in a semi-structured interview. The interview will explore the physiotherapists' experience of changes in management (if any) after the educational intervention. This includes challenges, barriers and facilitating factors.

Intervention All procedures will be based on the physiotherapists assessment where individual needs and goals are embedded into the rehabilitation. The project will investigate whether priorities within assessment and choice of management change after the educational intervention. The educational program for the physiotherapists will run over 13 days and is divided into 3 overlapping modules.

Module 1 (5 days) - Evidence-based theory The module will focus on theoretical and practical aspects of the management of patients with back pain within a multidimensional framework. This includes differential diagnostics, social medicine measures, communication training with a focus on motivational interview and management of patients with dominant cognitive and emotional factors.

An evidence-based overview of contributing factors to the pain experience will be addressed including lifestyle, emotions, cognitions, response to pain including protective movement strategies, co-morbidity, activity level, physical/mental stress, patho-anatomy, nervous system sensitivity and social factors.

Module 2 (3 days) - Masterclass Masterclass in where two experienced clinicians from the project group will demonstrate patient examinations and management of complex low back patients. The purpose is to help the participants gain insight into clinical application of relevant multi-dimensional management of disabling low back pain. These demonstrations provide the platform for the following module 3.

Module 3 (5 days) - Clinical supervision In the supervision sessions the participants receive training/guidance in integrating the theoretical and practical skills from the previous modules. Feedback/evaluation from supervisors ensures that the participants adapt a multi-dimensional perspective in their patient management. Competency is tested here

Conditions

Low Back Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Standard physiotherapy for low back pain in a municipality setting

Intervention Type: PROCEDURE

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 group

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

Standard physiotherapy for low back pain in a municipality setting

Intervention Type: PROCEDURE

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.

Interventions

Standard physiotherapy for low back pain in a municipality setting

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spine Centre of Southern Denmark

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Thorvaldur Skuli Palsson

Head of research,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thorvaldur S Palsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

Spine Center of Southern Denmark

Middelfart, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Back pain in Municipalities

Identifier Type: -

Identifier Source: org_study_id