Non-traumatic Low Back PainCALM-EDNCT07375914
Comprehensive Biopsychosocial Approach for Acute Low Back Pain Management in the Emergency Department: a Stepped-wedge Cluster-randomized Clinical Trial
A study testing Biopsychosocial intervention in people with Non-traumatic Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Non-traumatic Low Back Pain
- What is being tested?
- Biopsychosocial intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 782 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2026to 14 Jun 2027
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Presence of a 'red flag' according to HAS guidelines, including: motor neurological deficit or cauda equina syndrome, non-mechanical pain, trauma, active neoplastic disease or history of inflammatory rheumatism, suspected osteoarticular infection, recent spinal surgery with worsening symptoms, suspected acute vascular pathology, prolonged use of medications or corticosteroids, significant structural spinal deformity, or deterioration of general health.
- Inability to attend the 3-month follow-up.
- Poor command of French.
- Patient under guardianship/curatorship or deprived of liberty.
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Emergency department, Hôpital Pitié Salpêtrière
Paris
Héloise BANNELIER, Doctor, + 33 6 48 07 86 23, heloise.bannelier@aphp.fr
Yonathan FREUND, PU-PH, +33 1 42 17 72 82, yonathan.freund@aphp.fr
About this study
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. Non-pharmacological treatments, including exercise therapy and psychological support, show promising results but remain hampered by methodological biases and small sample sizes.
A biopsychosocial approach that combines pharmacological treatments, physical therapy, psychological support and social interventions has demonstrated moderate improvements in pain and function for chronic low back pain but remains insufficiently studied for acute presentations. French guidelines advocate a combined strategy involving paracetamol, NSAIDs, physical activity and psychosocial risk assessment. However, a French multicentre retrospective study highlighted marked heterogeneity in clinical practice, along with a low adoption rate (<10 %) of these recommendations in emergency departments, underscoring the need to strengthen adherence to evidence-based management strategies. We hypothesise that a multimodal intervention targeting physicians (guideline reminders) and patients (information on disease progression and multidisciplinary care plans), to enable the systematic implementation of all aspects of a biopsychosocial approach in emergency departments, could reduce short-term pain and disability in patients with acute low back pain.
- Conditions
- Non-traumatic Low Back Pain
- Being tested
- Biopsychosocial intervention
- Keywords
- Emergency medicine, Acute Low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsychosocial interventionOther
The biopsychosocial intervention consists of a structured program implemented in participating emergency departments. It includes a standardized 3-hour online training session for physicians covering evidence-based management of acute low back pain, rational pharmacological use, promotion of physical activity, and consideration of psychosocial factors. A summary sheet will be given with key recommendations during the period. For patients, short educational materials provide information on typical recovery, self-management strategies, and appropriate follow-up. The intervention is introduced sequentially across 12 centers according to a stepped-wedge randomization schedule, with each site moving from control to intervention while maintaining standard emergency care.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Usual care - Standard care for acute non-specific low back pain at clinician's discretion |
| Intervention group | Experimental | Biopsychosocial approach Receives: Other: Biopsychosocial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Interference Score at 7 days
Pain interference score at 7 days, assessed using the Pain Interference subscale of the Brief Pain Inventory - Short Form (BPI-SF). The score is calculated as the mean of 7 items (each rated 0-10) and reported on a 0-100 scale
Measured: 7 days
Secondary outcomes (8)
Pain intensity at 7 days, measured by the BPI SF intensity score.
Measured: 7 days
Number of pain-free days after the emergency department visit
Number of days with BPI intensity at 0
Measured: 7 days
Proportion of patients pain free at 7 days
Measured: 7 days
Number of days off work
Number of days off work at 7 days and at 3 months.
Measured: 7 days and 3 months.
Functional disability
Functional disability at 3 months, measured using the Roland-Morris Disability Questionnaire.
Measured: 3 months
Patient satisfaction and quality of life
Patient satisfaction and quality of life at 3 months, assessed using the EQ-5D-5L
Measured: 3 months
Number of X-rays, CT scans, and MRI scans of the spine performed
Measured: 3 months
Total amount of opioids consumed
Total amount of opioids consumed at 7 days and at 3 months (in morphine equivalent).
Measured: 7 days and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start14 Apr 2026
- Primary completion14 Apr 2027 (estimated)
- Study completion14 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-traumatic Low Back PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 782 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Héloïse BANNELIER, Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375914
- Sponsor's protocol ID
- APHP251083
- Other IDs
- IDRCB: 2025-A01588-41
- Acronym
- CALM-ED
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- CALM-ED / APHP251083
- Conditions
- Non-traumatic Low Back Pain
- Keywords
- Emergency medicine, Acute Low back pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 782 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 14 Jun 2027 (estimated)
- First posted
- 29 Jan 2026 (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.
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. Non-pharmacological treatments, including exercise therapy and psychological support, show promising results but remain hampered by methodological biases and small sample sizes.
A biopsychosocial approach that combines pharmacological treatments, physical therapy, psychological support and social interventions has demonstrated moderate improvements in pain and function for chronic low back pain but remains insufficiently studied for acute presentations. French guidelines advocate a combined strategy involving paracetamol, NSAIDs, physical activity and psychosocial risk assessment. However, a French multicentre retrospective study highlighted marked heterogeneity in clinical practice, along with a low adoption rate (<10 %) of these recommendations in emergency departments, underscoring the need to strengthen adherence to evidence-based management strategies. We hypothesise that a multimodal intervention targeting physicians (guideline reminders) and patients (information on disease progression and multidisciplinary care plans), to enable the systematic implementation of all aspects of a biopsychosocial approach in emergency departments, could reduce short-term pain and disability in patients with acute low back pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Usual care - Standard care for acute non-specific low back pain at clinician's discretion |
| Intervention group | Experimental | Other: Biopsychosocial interventionBiopsychosocial approach |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- Presence of a 'red flag' according to HAS guidelines, including: motor neurological deficit or cauda equina syndrome, non-mechanical pain, trauma, active neoplastic disease or history of inflammatory rheumatism, suspected osteoarticular infection, recent spinal surgery with worsening symptoms, suspected acute vascular pathology, prolonged use of medications or corticosteroids, significant structural spinal deformity, or deterioration of general health.
- Inability to attend the 3-month follow-up.
- Poor command of French.
- Patient under guardianship/curatorship or deprived of liberty.
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Biopsychosocial interventionThe biopsychosocial intervention consists of a structured program implemented in participating emergency departments. It includes a standardized 3-hour online training session for physicians covering evidence-based management of acute low back pain, rational pharmacological use, promotion of physical activity, and consideration of psychosocial factors. A summary sheet will be given with key recommendations during the period. For patients, short educational materials provide information on typical recovery, self-management strategies, and appropriate follow-up. The intervention is introduced sequentially across 12 centers according to a stepped-wedge randomization schedule, with each site moving from control to intervention while maintaining standard emergency care. | Other | Intervention group |
Primary outcome
Pain Interference Score at 7 days
Time frame: 7 days
Pain interference score at 7 days, assessed using the Pain Interference subscale of the Brief Pain Inventory - Short Form (BPI-SF). The score is calculated as the mean of 7 items (each rated 0-10) and reported on a 0-100 scale
8 secondary outcomes
Pain intensity at 7 days, measured by the BPI SF intensity score.
Time frame: 7 days
Number of pain-free days after the emergency department visit
Time frame: 7 days
Proportion of patients pain free at 7 days
Time frame: 7 days
Number of days off work
Time frame: 7 days and 3 months.
Functional disability
Time frame: 3 months
Patient satisfaction and quality of life
Time frame: 3 months
Number of X-rays, CT scans, and MRI scans of the spine performed
Time frame: 3 months
Total amount of opioids consumed
Time frame: 7 days and 3 months
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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.
Héloïse BANNELIER, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsychosocial intervention in people with Non-traumatic Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 5 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 8 Oct 2026. 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 France. 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 Héloïse BANNELIER, Doctor (+ 33 6 48 07 86 23, heloise.bannelier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Interference Score at 7 days (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.