Clinical trial NCT05794373: Education of Municipality-based Physiotherapists in Managing Disabling Low Back Pain - an Observational Study
Official title: Education of Municipality-based Physiotherapists in Managing Disabling Low Back Pain - an Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Low Back Pain
Keywords: Chronic low back pain
Rehabilitation
Physiotherapy
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Spine Centre of Southern Denmark
First posted: 2023-04-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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

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

Eligibility criteria: The following criteria apply for the patients entering the study

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

Primary outcomes:
measure: Disability
timeFrame: At baseline and 3 months after starting rehabilitation
Secondary outcomes:
measure: Pain intensity
timeFrame: At baseline and 3 months after starting rehabilitation
measure: Emotional and cognitive functioning
timeFrame: At baseline and 3 months after starting rehabilitation
measure: Sick leave from work
timeFrame: At baseline and 3 months after starting rehabilitation
measure: Patient Assessment of Transitions in Healthcare
timeFrame: 3 months after starting rehabilitation
Other outcomes:
measure: Checklist to determine the competency of clinicians
timeFrame: Up to 24 weeks after the project period has ended
measure: Barriers and facilitators for implementing new knowledge in clinical practice - qualitative interview
timeFrame: Up to 24 weeks after the project period has ended
Locations:
city: Middelfart
country: Denmark
facility: Spine Center of Southern Denmark
Study officials:
affiliation: Aalborg University Hospital
name: Thorvaldur S Palsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: