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New treatment option for Non-traumatic Low Back Pain
Official title Comprehensive Biopsychosocial Approach for Acute Low Back Pain Management in the Emergency Department: a Stepped-wedge Cluster-randomized Clinical Trial
ClinicalTrials.gov ID: NCT07375914
What this study is testing
- What it's testing
- Acute low back pain, the second leading cause of medical consultations in France, poses a major public health challenge, particularly because of its high risk of progressing to chronic low back pain-the leading cause worldwide of years lived with disability. Pharmacological treatments such as paracetamol, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and muscle relaxants show limited benefit in terms of pain intensity or functional disability.
- 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 55
You may be able to join if
- Patients aged 18 to 55 presenting to a participating emergency department, and
- Presenting with acute non-traumatic low back pain, newly developed or worsened within the past 7 days.
- Moderate to severe pain, defined as a score of ≥4 on a 0-10 numerical rating scale.
- Provision of informed consent after being given the information sheet.
- Patients covered by social security (excluding AME).
You likely can't join if
- Presence of a 'red flag' according to HAS guidelines, including: motor neurological deficit or cauda equina syndrome, non-mechanical pain, trauma...
- Inability to attend the 3-month follow-up.
- Poor command of French.
- Patient under guardianship/curatorship or deprived of liberty.
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
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 - 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 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.