Low Back PainEdu1stNCT06832852
Which Model of Care is the Most Cost-effective in the Treatment of Musculoskeletal Disorders?
A study testing Stepped care, Rehabilitation Care and Medical Care in people with Low Back Pain and Neck Pain, run by Laval University at 1 site in Canada.
Trial summary
As musculoskeletal disorders (MSKDs) reach epidemic proportions in Canada, access to the public health system for those who suffer from them is increasingly difficult. One of the main barriers is the delays to see a publicly funded health professional. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Neck Pain, Anterior Knee Pain Syndrome
- What is being tested?
- Stepped care, Rehabilitation Care and Medical Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jan 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- present with one of the four targeted MSKDs (low back pain, neck pain, anterior knee pain, rotator cuff-related shoulder pain).
- have had pain for at least 6 weeks.
- For low back pain (LBP): 1) non-specific LBP with or without radiation to the lower limbs, 2) minimal score of 15 on the ODI.
- For neck pain : 1) non-specific neck pain with or without radiation to the upper limbs, 2) minimal score of 21 on the NDI.
- For anterior knee pain : 1) anterior knee pain during walking, running or going up or down stairs, or during at least two activities among: kneeling, squatting, and resisted knee extension, 2) maximum score of 79 on the KOS-ADL.
- For rotator cuff-related shoulder pain : 1) minimal score of 15 on the QuickDASH, and 2) shoulder pain attributed to a rotator cuff-related shoulder pain using diagnostic guidelines of the British Elbow and Shoulder Society.
Who cannot join
- Unavailable to participate during the 24 weeks of the study.
- Do not understand French or English.
- Diagnosis of rheumatoid, inflammatory or neurodegenerative diseases.
- Received a corticosteroid injection in the previous 3 months.
- Cognitive problems interfering (Mini-Mental State Examination ≥ 24).
- Received a corticosteroid injection in the previous 3 months.
Show all 11Show fewer
- Less than 6 weeks since an intervention for their condition (including performing prescribed condition-specific exercises or taking prescribed medication).
- For low back pain (LBP): 1) LBP related to specific conditions (e.g., vertebral fracture, infections, neuropathic pain [>4 at the DN4 questionnaire]), 2) history of spine surgery or signs of upper motor neuron lesions (bilateral paresthesia, hyperreflexia or spasticity)..
- For neck pain : 1) neck pain related to specific conditions (e.g.; vertebral fracture, infections, neuropathic pain [>4 at the DN4 questionnaire]), 2) history of spine surgery or signs of upper motor neuron lesions.
- For anterior knee pain : 1) history of knee surgery or patellar dislocation, 2) pain believed to originate either from meniscus or from any knee ligament.
- For rotator cuff-related shoulder pain : 1) history of shoulder surgery, dislocations, fractures or capsulitis, 2) full thickness rotator cuff tear identified by imagery or clinical tests (lag signs and gross weakness).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for interdisciplinary research in rehabilitation and social integration (Cirris)
Québec, Quebec, G1M2S8
Jean Tittley, PT, MSc, 418-529-9141, jean.tittley@cirris.ulaval.ca
Jean-Sebastien Roy, PT, PhD
About this study
Official title: Is a Stepped Model of Care Cost-effective Compared to Usual Care for Musculoskeletal Disorders? a Randomized Controlled Trial
As musculoskeletal disorders (MSKDs) reach epidemic proportions in Canada, access to the public health system for those who suffer from them is increasingly difficult. One of the main barriers is the delays to see a publicly funded health professional. New models of care must therefore be developed to ensure better access. We have previously shown that not all patients with a MSKD need to be closely followed by a health professional as for a large proportion of patients simply educating them is enough to resolve their MSKD. A stepped care model where education would be given first before deciding if patients need a more extensive follow-up should be explored. This project will compare the effectiveness of a Stepped Care Model to that of the two most widely used models of care: Usual Medical Care and Usual Rehabilitation Care. We think that a Stepped Care Model will be as effective to reduce functional limitations, but will lead to lower healthcare costs.
Adults (n=369) with a MSKD will be randomly assigned to one of the intervention groups: Stepped Care, Usual Medical Care (physician-led intervention: e.g., advice/education, pharmacological pain management), or Usual Rehabilitation Care (physiotherapist-led intervention: e.g., advice/education, exercises). Participants in the Stepped Care Group will take part in two education sessions during the first 6 weeks. After 6 weeks, those who still have clinically important symptoms will receive follow-up rehabilitation interventions, while those who don't will be considered recovered and will have no further intervention. Primary (functional limitations) and secondary (e.g., pain, quality of life) outcomes will be assessed at baseline, and at 6, 12 and 24 weeks, and costs estimate will be established for each model of care. Knowing the urgent need for an overhaul of services to reduce wait times, the Stepped Care Model proposed could be a solution to improve access to health services without compromising quality of care.
Read the detailed description
Musculoskeletal disorders (MSKDs) are a leading cause of global disability, pain and work disability. Even if they are not fatal, they are disabling and their care places a significant burden on the healthcare system. Knowing that early intervention improves clinical outcomes, the healthcare system must ensure that those affected have access to the care they need, which is currently not the case. Optimizing the use of resources through the development of innovative and effective interventions must therefore be addressed. In randomized controlled trials (RCTs) conducted by our team, we have demonstrated that not all patients with MSKDs need to be closely followed by a health professional as for a large proportion of patients simply educating them is enough to resolve their MSKD. As healthcare costs escalate, using a Stepped Care Model in which patient education is offered first, providing usual care only to those whose symptoms have not resolved might lead to more efficient healthcare use and lower costs. The primary objective of this RCT is to establish the effectiveness of a new model of care for MSKDs by comparing a Stepped Care Model to the two most widely used models of care: Usual Medical Care and Usual Rehabilitation Care. A secondary objective will be to compare the costs associated with each of these care models. We hypothesize that a Stepped Care Model will be as effective as Usual Medical and Rehabilitation Care to reduce functional limitations, but will lead to lower costs.
In this pragmatic parallel-group RCT, 369 adults presenting a MSKDs will be randomly assigned to one of the intervention groups: 1) Stepped Care, 2) Usual Medical Care (physician-led intervention [up to 3 appointments within 12 weeks]: e.g., advice/education, pharmacological pain management), 3) Usual Rehabilitation Care (physiotherapist-led intervention [up to 10 appointments within 12 weeks]: e.g., advice/education, exercises). During the first 6 weeks of the study, participants in the Stepped Care Group will take part in a self-management education program that includes two education sessions with a physiotherapist; after 6 weeks, those still experiencing clinically important symptoms will receive follow-up rehabilitation interventions (up to 5 sessions within 6 weeks), while those not experiencing clinically important symptoms will be considered recovered and will have no further intervention. The primary (functional limitations) and secondary outcomes (e.g., pain severity, health-related quality of life, pain-related fear, pain self-efficacy), assessed at baseline and at 6, 12 and 24 weeks, will be compared between the groups using repeated measures analyses (linear mixed models). Costs estimate from the public payer and patient perspective will be established (including incremental cost-effectiveness and cost-utility ratios) and compare between care models (one-way ANOVA). Our research team has all the expertise (health services organization, medicine, rehabilitation, biostatistics, health economics) necessary to carry out this project. Knowing the urgent need for an overhaul of services to reduce wait times and ensure equitable access, the Stepped Care Model proposed could be a solution to improve access to health services without compromising quality of care. If the results are conclusive, they would lay the foundation for a future pan-Canadian trial examining the benefits of implementing such a model into the public healthcare system.
- Being tested
- Stepped care, Rehabilitation Care, Medical Care
- Keywords
- Stepped-Care, Rehabilitation, Musculoskeletal Disorders, Education, Medical Care
- Medical subject headings
- Low Back Pain, Neck Pain, Patellofemoral Pain Syndrome, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped careOther
During the first education session, participants will be provided with information pertaining to painful area, basic pain science, injury specific advice on load management, pain and activity management, lifestyle factors and physical activity. A general physical activity will be recommended (150-300 minutes of moderate-intensity activity per week). Then, participants will be directed to a website developed by the research team and patient partners. The website includes explanations of the various topics discussed during the session , explanatory videos, and summarized information. During the second educational session, the participant's condition will be reviewed, and their understanding of the topics covered in the first session and on the website will be assessed. A follow-up on the website will also be conducted. The physiotherapist will then answer the participant's questions and provide personalized advice based on their condition, along with long-term recommendations.
Rehabilitation CareOther
The pragmatic rehabilitation program will include exercises aimed at improving strength, endurance, flexibility, capacity to sustain mechanical load and dynamic control. Manual therapy may be provided during the sessions, based on pragmatic clinical decision-making. Participants will also receive information pertaining to the painful area and advice on pain and load management, and on activity modification, integrated across the sessions.
Medical CareOther
The pragmatic medical intervention may include pharmacological management, education, physiotherapy referral or referral to a specialist as deemed necessary.
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care Group | Experimental | During the first 6 weeks, participants will take part in a self-management education program and will be offered two individual educational sessions provided by a physiotherapist (PT). At the 6-week follow-up evaluation, the score on a region-specific patient-reported outcome measure will be used to determine if the condition is resolved or unresolved. Those no longer experiencing clinically important symptoms at the 6-week follow-up will be considered resolved and will have no further intervention. Those with remaining clinically important symptoms will receive follow-up interventions by a PT with up to 5 sessions over 6 weeks. The rehabilitation program will be similar to the one received by the participants in the Usual Rehabilitation Care Group. Receives: Other: Stepped care |
| Usual Rehabilitation Care Group | Active comparator | Participants will take part in a pragmatic 12-week physiotherapist (PT)-led rehabilitation program. It will include a maximum of 10 supervised meetings of 30 minutes each and an individualized home exercise program of 20-30 minutes to be performed 3-4 times per week. Receives: Other: Rehabilitation Care |
| Usual Medical Care Group | Active comparator | Participants will take part in a 12-week family physician (FP)-led program based on best practices and CPGs. It will include a maximum of 3 meetings over 12 weeks with a FP. Receives: Other: Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional limitations
Functional limitations will be evaluated using the Pain Interference subscale of the Brief Pain Inventory (BPI). The Pain Interference subscale (7 items) measures the level of interference with function caused by pain.
Measured: 24 weeks after baseline
Secondary outcomes (40)
Functional limitations
Functional limitations will be evaluated using the Pain Interference subscale of the Brief Pain Inventory (BPI). The Pain Interference subscale (7 items) measures the level of interference with function caused by pain.
Measured: 6 weeks after baseline
Functional limitations
Functional limitations will be evaluated using the Pain Interference subscale of the Brief Pain Inventory (BPI). The Pain Interference subscale (7 items) measures the level of interference with function caused by pain.
Measured: 12 weeks after baseline
Pain Severity
Pain severity will be evaluated using the Pain Severity subscale of the Brief Pain Inventory. The Pain Severity subscale of the BPI includes four items that measure pain intensity.
Measured: 6 weeks after baseline
Pain Severity
Pain severity will be evaluated using the Pain Severity subscale of the Brief Pain Inventory. The Pain Severity subscale of the BPI includes four items that measure pain intensity.
Measured: 12 weeks after baseline
Pain Severity
Pain severity will be evaluated using the Pain Severity subscale of the Brief Pain Inventory. The Pain Severity subscale of the BPI includes four items that measure pain intensity.
Measured: 24 weeks after baseline
Health-related quality of life
Health-related quality of life will be measured using the EQ-5D-5L. EQ-5D-5L is a 5-item generic HRQoL questionnaire covering five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The combined dimensions describe 55 = 3125 theoretically possible states of health that can be converted into a weighted index score.
Measured: 6 weeks after baseline
Health-related quality of life
Health-related quality of life will be measured using the EQ-5D-5L. EQ-5D-5L is a 5-item generic HRQoL questionnaire covering five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The combined dimensions describe 55 = 3125 theoretically possible states of health that can be converted into a weighted index score.
Measured: 12 weeks after baseline
Health-related quality of life
Health-related quality of life will be measured using the EQ-5D-5L. EQ-5D-5L is a 5-item generic HRQoL questionnaire covering five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The combined dimensions describe 55 = 3125 theoretically possible states of health that can be converted into a weighted index score.
Measured: 24 weeks after baseline
Pain-related fear
Pain-related fear will be evaluated using the Tampa Scale for Kinesiophobia. The Tampa Scale for Kinesiophobia is a 11-item scale measuring beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging.
Measured: 6 weeks after baseline
Pain-related fear
Pain-related fear will be evaluated using the Tampa Scale for Kinesiophobia. The Tampa Scale for Kinesiophobia is a 11-item scale measuring beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging.
Measured: 12 weeks after baseline
Pain-related fear
Pain-related fear will be evaluated using the Tampa Scale for Kinesiophobia. The Tampa Scale for Kinesiophobia is a 11-item scale measuring beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging.
Measured: 24 weeks after baseline
Pain catastrophizing
Pain catastrophizing will be evaluated using the Pain Catastrophizing Scale. The Pain Catastrophizing Scale is a 13-item scale aiming to identify catastrophic thoughts about pain.
Measured: 6 weeks after baseline
Pain catastrophizing
Pain catastrophizing will be evaluated using the Pain Catastrophizing Scale. The Pain Catastrophizing Scale is a 13-item scale aiming to identify catastrophic thoughts about pain.
Measured: 12 weeks after baseline
Pain catastrophizing
Pain catastrophizing will be evaluated using the Pain Catastrophizing Scale. The Pain Catastrophizing Scale is a 13-item scale aiming to identify catastrophic thoughts about pain.
Measured: 24 weeks after baseline
Pain self-efficacy
Pain self-efficacy will be evaluated using the Pain Self-Efficacy Questionnaire. The Pain Self-Efficacy Questionnaire consists of 10 items utilized to measure patient's confidence in performing daily activities despite of pain.
Measured: 6 weeks after baseline
Pain self-efficacy
Pain self-efficacy will be evaluated using the Pain Self-Efficacy Questionnaire. The Pain Self-Efficacy Questionnaire consists of 10 items utilized to measure patient's confidence in performing daily activities despite of pain.
Measured: 12 weeks after baseline
Pain self-efficacy
Pain self-efficacy will be evaluated using the Pain Self-Efficacy Questionnaire. The Pain Self-Efficacy Questionnaire consists of 10 items utilized to measure patient's confidence in performing daily activities despite of pain.
Measured: 24 weeks after baseline
Anxiety and depressive symptoms
Anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale. The Hospital Anxiety and Depression Scale is a 14-item self-administered questionnaire used to screen the presence of depression and anxiety.
Measured: 6 weeks after baseline
Anxiety and depressive symptoms
Anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale. The Hospital Anxiety and Depression Scale is a 14-item self-administered questionnaire used to screen the presence of depression and anxiety.
Measured: 12 weeks after baseline
Anxiety and depressive symptoms
Anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale. The Hospital Anxiety and Depression Scale is a 14-item self-administered questionnaire used to screen the presence of depression and anxiety.
Measured: 24 weeks after baseline
Region-specific symptoms and functional limitations - Low back pain
The modified Oswestry Disability Index is a 10-item questionnaire that assesses the interference of low back pain with activities of daily living. The modified Oswestry Disability Index will only be filled by participants with low back pain.
Measured: 6 weeks after baseline
Region-specific symptoms and functional limitations - Low back pain
The modified Oswestry Disability Index is a 10-item questionnaire that assesses the interference of low back pain with activities of daily living. The modified Oswestry Disability Index will only be filled by participants with low back pain.
Measured: 12 weeks after baseline
Region-specific symptoms and functional limitations - Low back pain
The modified Oswestry Disability Index is a 10-item questionnaire that assesses the interference of low back pain with activities of daily living. The modified Oswestry Disability Index will only be filled by participants with low back pain.
Measured: 24 weeks after baseline
Region-specific symptoms and functional limitations - Neck pain
The Neck Disability Index is a 10-item questionnaire that measures a patient's self-reported neck pain-related disability. The Neck Disability Index will only be filled by participants with neck pain.
Measured: 6 weeks after baseline
Region-specific symptoms and functional limitations - Neck pain
The Neck Disability Index is a 10-item questionnaire that measures a patient's self-reported neck pain-related disability. The Neck Disability Index will only be filled by participants with neck pain.
Measured: 12 weeks after baseline
Region-specific symptoms and functional limitations - Neck pain
The Neck Disability Index is a 10-item questionnaire that measures a patient's self-reported neck pain-related disability. The Neck Disability Index will only be filled by participants with neck pain.
Measured: 24 weeks after baseline
Region-specific symptoms and functional limitations - Rotator cuff-related shoulder pain
The QuickDASH is an 11-item questionnaire, validated in individuals with rotator cuff-related shoulder pain, addressing the level of difficulty in performing daily activities and the severity of the symptoms of the upper limbs. The QuickDASH will only be filled by participants with rotator cuff-related shoulder pain.
Measured: 6 weeks after baseline
Region-specific symptoms and functional limitations - Rotator cuff-related shoulder pain
The QuickDASH is an 11-item questionnaire, validated in individuals with rotator cuff-related shoulder pain, addressing the level of difficulty in performing daily activities and the severity of the symptoms of the upper limbs. The QuickDASH will only be filled by participants with rotator cuff-related shoulder pain.
Measured: 12 weeks after baseline
Region-specific symptoms and functional limitations - Rotator cuff-related shoulder pain
The QuickDASH is an 11-item questionnaire, validated in individuals with rotator cuff-related shoulder pain, addressing the level of difficulty in performing daily activities and the severity of the symptoms of the upper limbs. The QuickDASH will only be filled by participants with rotator cuff-related shoulder pain.
Measured: 24 weeks after baseline
Region-specific symptoms and functional limitations - Anterior knee pain
The Knee Outcome Survey Activities of Daily Living Scale (KOS-ADLS) is a 14-item knee-specific questionnaire that evaluates symptoms and functional limitations. The KOS-ADLS will only be filled by participants with anterior knee pain.
Measured: 6 weeks after baseline
Region-specific symptoms and functional limitations - Anterior knee pain
The Knee Outcome Survey Activities of Daily Living Scale (KOS-ADLS) is a 14-item knee-specific questionnaire that evaluates symptoms and functional limitations. The KOS-ADLS will only be filled by participants with anterior knee pain.
Measured: 12 weeks after baseline
Region-specific symptoms and functional limitations - Anterior knee pain
The Knee Outcome Survey Activities of Daily Living Scale (KOS-ADLS) is a 14-item knee-specific questionnaire that evaluates symptoms and functional limitations. The KOS-ADLS will only be filled by participants with anterior knee pain.
Measured: 24 weeks after baseline
Health costs
Health costs will be estimated using the CoPaQ. The CoPaQ measures patients' costs, including those of informal caregivers. It includes questions on costs associated with treatments such as copays, transport to sessions, child care, time off work, and loss in revenue.
Measured: 12 weeks after baseline
Health costs
Health costs will be estimated using the CoPaQ. The CoPaQ measures patients' costs, including those of informal caregivers. It includes questions on costs associated with treatments such as copays, transport to sessions, child care, time off work, and loss in revenue.
Measured: 24 weeks after baseline
Healthcare resource utilization
Healthcare resource utilization will be estimated using a ressource utilization questionnaire. The questionnaire will include questions on appointment with family physicians, physiotherapists or any other health professionals, medical imaging, laboratory tests, pain medication and indirect.
Measured: 12 weeks after baseline
Healthcare resource utilization
Healthcare resource utilization will be estimated using a ressource utilization questionnaire. The questionnaire will include questions on appointment with family physicians, physiotherapists or any other health professionals, medical imaging, laboratory tests, pain medication and indirect.
Measured: 24 weeks after baseline
Participants' satisfaction with their condition
Participants' satisfaction with their condition will be assessed using the Patient Acceptable Symptom State (PASS). It asks patients whether they are satisfied with their current state and to rate their satisfaction on a 0-10 numeric scale.96
Measured: 6 weeks after baseline
Participants' satisfaction with their condition
Participants' satisfaction with their condition will be assessed using the Patient Acceptable Symptom State (PASS). It asks patients whether they are satisfied with their current state and to rate their satisfaction on a 0-10 numeric scale.96
Measured: 12 weeks after baseline
Participants' satisfaction with their condition
Participants' satisfaction with their condition will be assessed using the Patient Acceptable Symptom State (PASS). It asks patients whether they are satisfied with their current state and to rate their satisfaction on a 0-10 numeric scale.96
Measured: 24 weeks after baseline
Satisfaction with treatment received
Participants will rate their satisfaction with treatment received ("not satisfied'', "satisfied'', "very much satisfied''), with the duration of treatments ("too short'', "long enough'', "too long''), with the frequency of treatments and with the time spent with the health professional during treatments ("not enough'', "just right'', "too much'') using a 3-item Likert scale.
Measured: 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start31 Jan 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Sebastien Roy, PT, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832852
- Sponsor's protocol ID
- 495615
- Acronym
- Edu1st
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are awaiting confirmation from the ethics research committee regarding permission to share individual participant data with other researchers. Once confirmed, we will outline the plan.
Publications
Roy JS, Masse-Alarie H, Dube MO, Pinard AM, Lamontagne M, Sole G, Tittley J, Laberge M, Dupuis F, Fiset F, Nduwimana I, McArthur E, Desmeules F. Effectiveness and Cost-Effectiveness of a Stepped Model of Care for Musculoskeletal Disorders: Protocol for a Multiarm Randomized Controlled Trial (Edu-First Trial). JMIR Res Protoc. 2025 Nov 19;14:e77574. doi: 10.2196/77574.
PubMed 41258669
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Stepped Model of Care Cost-effective Compared to Usual Care for Musculoskeletal Disorders? a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06832852
- Acronym / sponsor ID
- Edu1st / 495615
- Keywords
- Stepped-Care, Rehabilitation, Musculoskeletal Disorders, Education, Medical Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 18 Feb 2025 (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.
As musculoskeletal disorders (MSKDs) reach epidemic proportions in Canada, access to the public health system for those who suffer from them is increasingly difficult. One of the main barriers is the delays to see a publicly funded health professional. New models of care must therefore be developed to ensure better access. We have previously shown that not all patients with a MSKD need to be closely followed by a health professional as for a large proportion of patients simply educating them is enough to resolve their MSKD. A stepped care model where education would be given first before deciding if patients need a more extensive follow-up should be explored. This project will compare the effectiveness of a Stepped Care Model to that of the two most widely used models of care: Usual Medical Care and Usual Rehabilitation Care. We think that a Stepped Care Model will be as effective to reduce functional limitations, but will lead to lower healthcare costs.
Adults (n=369) with a MSKD will be randomly assigned to one of the intervention groups: Stepped Care, Usual Medical Care (physician-led intervention: e.g., advice/education, pharmacological pain management), or Usual Rehabilitation Care (physiotherapist-led intervention: e.g., advice/education, exercises). Participants in the Stepped Care Group will take part in two education sessions during the first 6 weeks. After 6 weeks, those who still have clinically important symptoms will receive follow-up rehabilitation interventions, while those who don't will be considered recovered and will have no further intervention. Primary (functional limitations) and secondary (e.g., pain, quality of life) outcomes will be assessed at baseline, and at 6, 12 and 24 weeks, and costs estimate will be established for each model of care. Knowing the urgent need for an overhaul of services to reduce wait times, the Stepped Care Model proposed could be a solution to improve access to health services without compromising quality of care.
Detailed description
Musculoskeletal disorders (MSKDs) are a leading cause of global disability, pain and work disability. Even if they are not fatal, they are disabling and their care places a significant burden on the healthcare system. Knowing that early intervention improves clinical outcomes, the healthcare system must ensure that those affected have access to the care they need, which is currently not the case. Optimizing the use of resources through the development of innovative and effective interventions must therefore be addressed. In randomized controlled trials (RCTs) conducted by our team, we have demonstrated that not all patients with MSKDs need to be closely followed by a health professional as for a large proportion of patients simply educating them is enough to resolve their MSKD. As healthcare costs escalate, using a Stepped Care Model in which patient education is offered first, providing usual care only to those whose symptoms have not resolved might lead to more efficient healthcare use and lower costs. The primary objective of this RCT is to establish the effectiveness of a new model of care for MSKDs by comparing a Stepped Care Model to the two most widely used models of care: Usual Medical Care and Usual Rehabilitation Care. A secondary objective will be to compare the costs associated with each of these care models. We hypothesize that a Stepped Care Model will be as effective as Usual Medical and Rehabilitation Care to reduce functional limitations, but will lead to lower costs.
In this pragmatic parallel-group RCT, 369 adults presenting a MSKDs will be randomly assigned to one of the intervention groups: 1) Stepped Care, 2) Usual Medical Care (physician-led intervention [up to 3 appointments within 12 weeks]: e.g., advice/education, pharmacological pain management), 3) Usual Rehabilitation Care (physiotherapist-led intervention [up to 10 appointments within 12 weeks]: e.g., advice/education, exercises). During the first 6 weeks of the study, participants in the Stepped Care Group will take part in a self-management education program that includes two education sessions with a physiotherapist; after 6 weeks, those still experiencing clinically important symptoms will receive follow-up rehabilitation interventions (up to 5 sessions within 6 weeks), while those not experiencing clinically important symptoms will be considered recovered and will have no further intervention. The primary (functional limitations) and secondary outcomes (e.g., pain severity, health-related quality of life, pain-related fear, pain self-efficacy), assessed at baseline and at 6, 12 and 24 weeks, will be compared between the groups using repeated measures analyses (linear mixed models). Costs estimate from the public payer and patient perspective will be established (including incremental cost-effectiveness and cost-utility ratios) and compare between care models (one-way ANOVA). Our research team has all the expertise (health services organization, medicine, rehabilitation, biostatistics, health economics) necessary to carry out this project. Knowing the urgent need for an overhaul of services to reduce wait times and ensure equitable access, the Stepped Care Model proposed could be a solution to improve access to health services without compromising quality of care. If the results are conclusive, they would lay the foundation for a future pan-Canadian trial examining the benefits of implementing such a model into the public healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stepped Care Group | Experimental | Other: Stepped careDuring the first 6 weeks, participants will take part in a self-management education program and will be offered two individual educational sessions provided by a physiotherapist (PT). At the 6-week follow-up evaluation, the score on a region-specific patient-reported outcome measure will be used to determine if the condition is resolved or unresolved. Those no longer experiencing clinically important symptoms at the 6-week follow-up will be considered resolved and will have no further intervention. Those with remaining clinically important symptoms will receive follow-up interventions by a PT with up to 5 sessions over 6 weeks. The rehabilitation program will be similar to the one received by the participants in the Usual Rehabilitation Care Group. |
| Usual Rehabilitation Care Group | Active comparator | Other: Rehabilitation CareParticipants will take part in a pragmatic 12-week physiotherapist (PT)-led rehabilitation program. It will include a maximum of 10 supervised meetings of 30 minutes each and an individualized home exercise program of 20-30 minutes to be performed 3-4 times per week. |
| Usual Medical Care Group | Active comparator | Other: Medical CareParticipants will take part in a 12-week family physician (FP)-led program based on best practices and CPGs. It will include a maximum of 3 meetings over 12 weeks with a FP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- present with one of the four targeted MSKDs (low back pain, neck pain, anterior knee pain, rotator cuff-related shoulder pain).
- have had pain for at least 6 weeks.
- For low back pain (LBP): 1) non-specific LBP with or without radiation to the lower limbs, 2) minimal score of 15 on the ODI.
- For neck pain : 1) non-specific neck pain with or without radiation to the upper limbs, 2) minimal score of 21 on the NDI.
- For anterior knee pain : 1) anterior knee pain during walking, running or going up or down stairs, or during at least two activities among: kneeling, squatting, and resisted knee extension, 2) maximum score of 79 on the KOS-ADL.
Key exclusion criteria (11 listed)
- Unavailable to participate during the 24 weeks of the study.
- Do not understand French or English.
- Diagnosis of rheumatoid, inflammatory or neurodegenerative diseases.
- Received a corticosteroid injection in the previous 3 months.
- Cognitive problems interfering (Mini-Mental State Examination ≥ 24).
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 |
|---|---|---|
| Stepped careDuring the first education session, participants will be provided with information pertaining to painful area, basic pain science, injury specific advice on load management, pain and activity management, lifestyle factors and physical activity. A general physical activity will be recommended (150-300 minutes of moderate-intensity activity per week). Then, participants will be directed to a website developed by the research team and patient partners. The website includes explanations of the various topics discussed during the session , explanatory videos, and summarized information. During the second educational session, the participant's condition will be reviewed, and their understanding of the topics covered in the first session and on the website will be assessed. A follow-up on the website will also be conducted. The physiotherapist will then answer the participant's questions and provide personalized advice based on their condition, along with long-term recommendations. | Other | Stepped Care Group |
| Rehabilitation CareThe pragmatic rehabilitation program will include exercises aimed at improving strength, endurance, flexibility, capacity to sustain mechanical load and dynamic control. Manual therapy may be provided during the sessions, based on pragmatic clinical decision-making. Participants will also receive information pertaining to the painful area and advice on pain and load management, and on activity modification, integrated across the sessions. | Other | Usual Rehabilitation Care Group |
| Medical CareThe pragmatic medical intervention may include pharmacological management, education, physiotherapy referral or referral to a specialist as deemed necessary. | Other | Usual Medical Care Group |
Primary outcome
Functional limitations
Time frame: 24 weeks after baseline
Functional limitations will be evaluated using the Pain Interference subscale of the Brief Pain Inventory (BPI). The Pain Interference subscale (7 items) measures the level of interference with function caused by pain.
40 secondary outcomes
Functional limitations
Time frame: 6 weeks after baseline
Functional limitations
Time frame: 12 weeks after baseline
Pain Severity
Time frame: 6 weeks after baseline
Pain Severity
Time frame: 12 weeks after baseline
Pain Severity
Time frame: 24 weeks after baseline
Health-related quality of life
Time frame: 6 weeks after baseline
Health-related quality of life
Time frame: 12 weeks after baseline
Health-related quality of life
Time frame: 24 weeks after baseline
Pain-related fear
Time frame: 6 weeks after baseline
Pain-related fear
Time frame: 12 weeks after baseline
Pain-related fear
Time frame: 24 weeks after baseline
Pain catastrophizing
Time frame: 6 weeks after baseline
Pain catastrophizing
Time frame: 12 weeks after baseline
Pain catastrophizing
Time frame: 24 weeks after baseline
Pain self-efficacy
Time frame: 6 weeks after baseline
Pain self-efficacy
Time frame: 12 weeks after baseline
Pain self-efficacy
Time frame: 24 weeks after baseline
Anxiety and depressive symptoms
Time frame: 6 weeks after baseline
Anxiety and depressive symptoms
Time frame: 12 weeks after baseline
Anxiety and depressive symptoms
Time frame: 24 weeks after baseline
Region-specific symptoms and functional limitations - Low back pain
Time frame: 6 weeks after baseline
Region-specific symptoms and functional limitations - Low back pain
Time frame: 12 weeks after baseline
Region-specific symptoms and functional limitations - Low back pain
Time frame: 24 weeks after baseline
Region-specific symptoms and functional limitations - Neck pain
Time frame: 6 weeks after baseline
Region-specific symptoms and functional limitations - Neck pain
Time frame: 12 weeks after baseline
Region-specific symptoms and functional limitations - Neck pain
Time frame: 24 weeks after baseline
Region-specific symptoms and functional limitations - Rotator cuff-related shoulder pain
Time frame: 6 weeks after baseline
Region-specific symptoms and functional limitations - Rotator cuff-related shoulder pain
Time frame: 12 weeks after baseline
Region-specific symptoms and functional limitations - Rotator cuff-related shoulder pain
Time frame: 24 weeks after baseline
Region-specific symptoms and functional limitations - Anterior knee pain
Time frame: 6 weeks after baseline
Region-specific symptoms and functional limitations - Anterior knee pain
Time frame: 12 weeks after baseline
Region-specific symptoms and functional limitations - Anterior knee pain
Time frame: 24 weeks after baseline
Health costs
Time frame: 12 weeks after baseline
Health costs
Time frame: 24 weeks after baseline
Healthcare resource utilization
Time frame: 12 weeks after baseline
Healthcare resource utilization
Time frame: 24 weeks after baseline
Participants' satisfaction with their condition
Time frame: 6 weeks after baseline
Participants' satisfaction with their condition
Time frame: 12 weeks after baseline
Participants' satisfaction with their condition
Time frame: 24 weeks after baseline
Satisfaction with treatment received
Time frame: 12 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Derived from this study: PubMed 41258669Roy JS, Masse-Alarie H, Dube MO, Pinard AM, Lamontagne M, Sole G, Tittley J, Laberge M, Dupuis F, Fiset F, Nduwimana I, McArthur E, Desmeules F. Effectiveness and Cost-Effectiveness of a Stepped Model of Care for Musculoskeletal Disorders: Protocol for a Multiarm Randomized Controlled Trial (Edu-First Trial). JMIR Res Protoc. 2025 Nov 19;14:e77574. doi: 10.2196/77574.
- Individual participant dataSharing planned: Undecided. We are awaiting confirmation from the ethics research committee regarding permission to share individual participant data with other researchers. Once confirmed, we will outline the plan.
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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.
Jean-Sebastien Roy, PT, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped care, Rehabilitation Care and Medical Care in people with Low Back Pain and Neck Pain, run by Laval University at 1 site in Canada.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Tittley, PT, MSc (1-418-529-9141, jean.tittley@cirris.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional limitations (time frame: 24 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06832852, which also lists 1 linked publication.
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 18 Feb 2025.