Low Back PainNCT05794373
Education of Municipality-based Physiotherapists in Managing Disabling Low Back Pain - an Observational Study
An observational study of Low Back Pain, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Standard physiotherapy for low back pain in a municipality setting
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Schedule of procedures and assessments
- 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.
- 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.
- Point 1 is repeated on an additional 100 patients who undergo rehabilitation after the physiotherapists have completed the course
- 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
- 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
- Being tested
- Standard physiotherapy for low back pain in a municipality setting
- Keywords
- Chronic low back pain, Rehabilitation, Physiotherapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physiotherapy for low back pain in a municipality settingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Standard physiotherapy for low back pain in a municipality setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At baseline and 3 months after starting rehabilitation
Secondary outcomes (4)
Pain intensity
Change in pain intensity between baseline and follow-up on a numeric rating scale (NRS: 0-10) Pain intensity scores (Average, best and worst). 0 is no pain; 10 is worst pain imaginable
Measured: At baseline and 3 months after starting rehabilitation
Emotional and cognitive functioning
Orebro Musculoskeletal Pain Questionnaire. The questionnaire captures psychological and emotional factors in musculoskeletal pain. In the study, the questionnaire is used as a screening tool to determine eligibility. The score ranges from 4-210 where a higher score indicates greater loss of function related to cognitive or emotional factors. A cut-off score for entering the study is set at 40
Measured: At baseline and 3 months after starting rehabilitation
Sick leave from work
Patients indicate whether they are on sick leave. If yes, whether they are on full sick leave or have reduced work capacity (indicated in hours per week) or normal work capacity
Measured: At baseline and 3 months after starting rehabilitation
Patient Assessment of Transitions in Healthcare
The participants evaluate the quality and coherence in management of their condition across sectors by indicate to what degree a range of statements on a 5 point Likert scales ranged from 'strongly disagree' to 'strongly agree'. The total score does not indicate a better or worse outcome but simply to what degree the statements apply to the patients' transition through the healthchare system
Measured: 3 months after starting rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Mar 2023
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Spine Centre of Southern Denmark
- Responsible party
- Principal investigator, Thorvaldur Skuli Palsson, Aalborg University Hospital
- Investigators
- Thorvaldur S Palsson, PhD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794373
- Sponsor's protocol ID
- Back pain in Municipalities
- Status last verified
- Aug 2024
- First submitted
- 3 Feb 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education of Municipality-based Physiotherapists in Managing Disabling Low Back Pain - an Observational Study
- ClinicalTrials.gov ID
- NCT05794373
- Acronym / sponsor ID
- Back pain in Municipalities
- Conditions
- Low Back Pain
- Keywords
- Chronic low back pain, Rehabilitation, Physiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Spine Centre of Southern Denmark
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- Point 1 is repeated on an additional 100 patients who undergo rehabilitation after the physiotherapists have completed the course
- 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
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Education group | – | Procedure: Standard physiotherapy for low back pain in a municipality settingPatients in this group undergo rehabilitation for back pain in a municipality setting with physiotherapists before the physiotherapists have participated in an educational intervention |
| Post-Education group | – | Procedure: Standard physiotherapy for low back pain in a municipality settingPatients in this group undergo rehabilitation for back pain in a municipality setting with physiotherapists after they have participated in an educational intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard physiotherapy for low back pain in a municipality settingPatients (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. | Procedure or surgery | Post-Education group, Pre-Education group |
Primary outcome
Disability
Time frame: At baseline and 3 months after starting rehabilitation
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)
4 secondary outcomes
Pain intensity
Time frame: At baseline and 3 months after starting rehabilitation
Emotional and cognitive functioning
Time frame: At baseline and 3 months after starting rehabilitation
Sick leave from work
Time frame: At baseline and 3 months after starting rehabilitation
Patient Assessment of Transitions in Healthcare
Time frame: 3 months after starting rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorvaldur S Palsson, PhD principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: At baseline and 3 months after starting rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.