Low Back Pain study: Rehabilitation Care vs Medical Care
Official title Which Model of Care is the Most Cost-effective in the Treatment of Musculoskeletal Disorders?
ClinicalTrials.gov ID: NCT06832852
What this study is testing
- What it's testing
- The study wants to find out if a stepped‑care approach, starting with education and only adding more care if needed, is as good as usual medical or rehabilitation care, but cheaper.
- Who it's for
- Adults with low back, neck, knee, or shoulder pain who can be randomly assigned to one of the three care models.
- What's involved
- Participants will receive either stepped care (two education sessions, then more care only if symptoms remain), usual medical care (doctor advice and medication), or usual rehabilitation care (physiotherapist advice and exercises). Outcomes like function, pain, and quality of life will be measured at several times.
- Time commitment
- The study lasts 24 weeks, with visits and assessments at baseline, 6, 12, and 24 weeks.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.