Recruiting

Observational Study

Sponsor:

Laval University

Code:

NCT06832852

Conditions

Low Back Pain

Neck Pain

Anterior Knee Pain Syndrome

Rotator-cuff Related Shoulder Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Stepped care

Rehabilitation Care

Medical Care

Study Details

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.

Conditions

Low Back Pain

Neck Pain

Anterior Knee Pain Syndrome

Rotator-cuff Related Shoulder Pain

Study ID

NCT06832852

Start date

Jan 31, 2025

Status verified date

Feb, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

369 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stepped Care Group

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.

active comparator: Usual Rehabilitation Care Group

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.

active comparator: Usual Medical Care Group

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.

Interventions

Stepped care

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 Care

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 Care

The pragmatic medical intervention may include pharmacological management, education, physiotherapy referral or referral to a specialist as deemed necessary.

Primary outcome measure

  • Functional limitations [ Time Frame: 24 weeks after baseline ]

Central Contacts and Locations

Central contacts

Jean Tittley, PT, MSc

1-418-529-9141jean.tittley@cirris.ulaval.ca

Locations

Centre for interdisciplinary research in rehabilitation and social integration (Cirris)

Recruiting

Quebec City, Quebec, Canada, G1M2S8

Contacts

Jean Tittley, PT, MSc

418-529-9141jean.tittley@cirris.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Feb 18, 2025

Last verified

Feb, 2025

Keywords

  • Stepped-Care
  • Rehabilitation
  • Musculoskeletal Disorders
  • Education
  • Medical Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2025-02-18.