Clinical trial NCT06832852: Which Model of Care is the Most Cost-effective in the Treatment of Musculoskeletal Disorders?
Official title: Is a Stepped Model of Care Cost-effective Compared to Usual Care for Musculoskeletal Disorders? a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Neck Pain
Anterior Knee Pain Syndrome
Rotator-cuff Related Shoulder Pain
Keywords: Stepped-Care
Rehabilitation
Musculoskeletal Disorders
Education
Medical Care
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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).

Primary outcomes:
measure: Functional limitations
timeFrame: 24 weeks after baseline
Secondary outcomes:
measure: Functional limitations
timeFrame: 6 weeks after baseline
measure: Functional limitations
timeFrame: 12 weeks after baseline
measure: Pain Severity
timeFrame: 6 weeks after baseline
measure: Pain Severity
timeFrame: 12 weeks after baseline
measure: Pain Severity
timeFrame: 24 weeks after baseline
measure: Health-related quality of life
timeFrame: 6 weeks after baseline
measure: Health-related quality of life
timeFrame: 12 weeks after baseline
measure: Health-related quality of life
timeFrame: 24 weeks after baseline
measure: Pain-related fear
timeFrame: 6 weeks after baseline
measure: Pain-related fear
timeFrame: 12 weeks after baseline
measure: Pain-related fear
timeFrame: 24 weeks after baseline
measure: Pain catastrophizing
timeFrame: 6 weeks after baseline
measure: Pain catastrophizing
timeFrame: 12 weeks after baseline
measure: Pain catastrophizing
timeFrame: 24 weeks after baseline
measure: Pain self-efficacy
timeFrame: 6 weeks after baseline
measure: Pain self-efficacy
timeFrame: 12 weeks after baseline
measure: Pain self-efficacy
timeFrame: 24 weeks after baseline
measure: Anxiety and depressive symptoms
timeFrame: 6 weeks after baseline
measure: Anxiety and depressive symptoms
timeFrame: 12 weeks after baseline
measure: Anxiety and depressive symptoms
timeFrame: 24 weeks after baseline
measure: Region-specific symptoms and functional limitations - Low back pain
timeFrame: 6 weeks after baseline
measure: Region-specific symptoms and functional limitations - Low back pain
timeFrame: 12 weeks after baseline
measure: Region-specific symptoms and functional limitations - Low back pain
timeFrame: 24 weeks after baseline
measure: Region-specific symptoms and functional limitations - Neck pain
timeFrame: 6 weeks after baseline
measure: Region-specific symptoms and functional limitations - Neck pain
timeFrame: 12 weeks after baseline
measure: Region-specific symptoms and functional limitations - Neck pain
timeFrame: 24 weeks after baseline
measure: Region-specific symptoms and functional limitations - Rotator cuff-related shoulder pain
timeFrame: 6 weeks after baseline
measure: Region-specific symptoms and functional limitations - Rotator cuff-related shoulder pain
timeFrame: 12 weeks after baseline
measure: Region-specific symptoms and functional limitations - Rotator cuff-related shoulder pain
timeFrame: 24 weeks after baseline
measure: Region-specific symptoms and functional limitations - Anterior knee pain
timeFrame: 6 weeks after baseline
measure: Region-specific symptoms and functional limitations - Anterior knee pain
timeFrame: 12 weeks after baseline
measure: Region-specific symptoms and functional limitations - Anterior knee pain
timeFrame: 24 weeks after baseline
measure: Health costs
timeFrame: 12 weeks after baseline
measure: Health costs
timeFrame: 24 weeks after baseline
measure: Healthcare resource utilization
timeFrame: 12 weeks after baseline
measure: Healthcare resource utilization
timeFrame: 24 weeks after baseline
measure: Participants' satisfaction with their condition
timeFrame: 6 weeks after baseline
measure: Participants' satisfaction with their condition
timeFrame: 12 weeks after baseline
measure: Participants' satisfaction with their condition
timeFrame: 24 weeks after baseline
measure: Satisfaction with treatment received
timeFrame: 12 weeks after baseline
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Centre for interdisciplinary research in rehabilitation and social integration (Cirris)
state: Quebec
Study officials:
affiliation: Laval University
name: Jean-Sebastien Roy, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: