Non-specific Low Back Pain (NSLBP)ESP-BACKNCT07434024
Erector Spinae Plane Block for Acute Low Back Pain
A study testing Erector Spinae Plane Block with isotonic saline and Erector Spinae Plane Block with local anesthetic in people with Non-specific Low Back Pain (NSLBP), run by University Hospital, Montpellier.
Trial summary
Non-Specific low back pain (NSLB) is an important public health problem with a major economic and social impact. It is defined by the location of pain, between the lower rib margins and the lumbar vertebrae. Medical management of Non-Specific low back pain injury focuses on reducing pain and its consequences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-specific Low Back Pain (NSLBP)
- What is being tested?
- Erector Spinae Plane Block with isotonic saline and Erector Spinae Plane Block with local anesthetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Jan 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥ 18 years);
- Non-specific low back pain (≤ 5 days);
- Pain score (VAS) ≥ 5 (during mobilization);
- Inability to walk easily (failure of the "Get Up and Go" test in less than 20 seconds).
Who cannot join
- Low back pain of known specific origin: spine surgery, spine trauma, discal hernia, facet joint, radicular (sciatica, cruralgia, meralgia paresthetica), muscle pain, cancer-related or rheumatological disease;
- Referred or chronic pain;
- Patients with opioids (acute or chronic pain and/or misuse);
- Contraindication to regional anaesthesia;
- Contraindication to ropivacaine, dexamethasone, sodium chloride, NSAID, paracetamol, tramadol;
- Known hypersensitivity to ropivacaine, dexamethasone, other amide-type local anesthetics, or any of the excipients;
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- Addiction to drugs, alcohol or medication;
- Patients with anticoagulants for a curative use (not preventive);
- Patients with cancer or risk of bone metastasis or; severe osteoporosis;
- Acute inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis…);
- Patient with severe hypotension or uncontrolled hypertension or; Heart Block (uncorrected second- or third-degree heart block without a pacemaker) or; severe bradycardia;
- Patients with severe liver or renal disease or peptic ulcer disease;
- Presence of infection or sepsis at the injection site;
- Patients with uncontrolled bacterial, viral, or protozoan infections or; systemic fungal infections or; active untreated tuberculosis or; active ocular herpes simplex infections;
- Patients with uncontrolled diabetes mellitus;
- Patients with glaucoma or history of severe glaucoma;
- Patients with severe psychiatric conditions;
- Subject unable to read or/and write (inability to complete a self-administered questionnaire);
- Unavailability for follow up during 6 months;
- Participation in another clinical trial involving an investigational medicinal product or medical device within 4 weeks preceding the screening date;
- Pregnancy in progress or planned during the study period or breastfeeding women (Art. L1121-5 of the French Public Health Code);
- Women of childbearing potential (WOCBP) without a negative of highly sensitive pregnancy test before inclusion or not using a highly effective method of contraception;
- Patients protected by law (Art. L1121-6 and L1121-8 of the French Public Health Code): Individuals deprived of their liberty by judicial or administrative decision, minors, adults under law protection or unable to express their consent or patient under guardianship or curatorship;
- Patients not covered by a French social security scheme or not benefiting from such a scheme;
- Absence of signed informed consent form before inclusion from the patient;
- Patient already included in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xavier Cadevila, MD PHD contact
About this study
Official title: Erector Spinae Plane Block for Acute Low Back Pain: a Prospective Double-blind Randomized Multicenter Study
Non-Specific low back pain (NSLB) is an important public health problem with a major economic and social impact. It is defined by the location of pain, between the lower rib margins and the lumbar vertebrae. Medical management of Non-Specific low back pain injury focuses on reducing pain and its consequences. Nowadays, no strategy has shown optimal effectiveness to improve outcome substantially. The ultrasound-guided erector spinae plane block (ESPB) is a well-known intermuscular compartment block. In the absence of red flag signs, ESPB can be performed for low back pain to reduce pain, decrease opiate requirements and limit emergency admissions for refractory pain. This study aims to evaluate the impact of the ESPB in patients suffering from NSLB.
Read the detailed description
The study is a multicenter randomized clinical trial. The patients are recruited on the day of admission in the emergency department for Non-Specific low back pain.They are randomly assigned to receive either regional anesthesia with a local anesthetic (ESP BLOCK Group) or placebo (CONTROL Group). The primary objective is to evaluate whether the ESPB is an effective treatment for patients with NSLB pain, by reducing pain and allowing immediate mobility. The secondary objectives of this study are multidimensional and aim to compare patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs), as well as clinical and economic outcomes, over a six-month follow-up period.
- Conditions
- Non-specific Low Back Pain (NSLBP)
- Being tested
- Erector Spinae Plane Block with isotonic saline, Erector Spinae Plane Block with local anesthetic
- Keywords
- Non-Specific low back pain ;, Erector Spinae Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block with isotonic salineProcedure or surgery
Ultrasound-guided erector spinae plane block performed under aseptic conditions by an experienced physician, consisting of an interfascial injection in the erector spinae plane using an isotonic saline solution.
Erector Spinae Plane Block with local anestheticProcedure or surgery
Ultrasound-guided erector spinae plane block performed under aseptic conditions by an experienced physician, consisting of an interfascial injection in the erector spinae plane using a local anesthetic solution.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (ESPB) | Experimental | A single injection will be performed at the erector spinae plane site, 20 ml of ropivacaine 0.2% then 8 mg of dexamethasone (2 ml) will be administered sequentially through the same needle using two separate syringes in order to prevent the risk of precipitation between the two solutions. The injection will be performed unilaterally or bilaterally as per the randomization stratification Receives: Procedure: Erector Spinae Plane Block with local anesthetic |
| Control group (placebo) | Placebo comparator | A single injection of 22 ml isotonic saline solution will be performed at the same anatomical site as the experimental group. To maintain the double-blind design, the saline solution will be administered sequentially through the same needle using two separate syringes (20 mL + 2 mL). The injection will also be performed unilaterally or bilaterally, according to the randomization stratification. Receives: Procedure: Erector Spinae Plane Block with isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Success of the treatment
The primary endpoint is the success of the treatment before hospital discharge defined by a composite criteria combining the reduction of pain on mobilization (50% decrease in pain intensity) and the validation of the "Get up and go" test (in less than 20 seconds).
Measured: 30 minutes post-procedure
Secondary outcomes (13)
VAS Pain assessments
The Visual Analog Scale (VAS) will provide a subjective evaluation of pain severity by the patient on a scale ranging from 0 to 10, where 0 signifies no pain and 10 represents the most intense pain imaginable. This measurement is essential for capturing the patient's own perception of pain following the intervention.
Measured: The day of procedure up to 6 months
Brief Pain Inventory (BPI) pain scores
The Brief Pain Inventory (BPI) questionnaire serves as a comprehensive tool for assessing the severity of pain and its impact on various aspects of daily life. By capturing detailed information about pain experiences, including its intensity, interference with daily activities, and emotional impact, the BPI facilitates a nuanced understanding of the patient's pain experience. The BPI includes 2 subdimensions (pain severity and pain interference) range from 0 (no pain or no interference) to 10 (worst imaginable pain / complete interference)
Measured: on day 14, month 3, and month 6
Consumption of rescue analgesics
Consumption of rescue analgesic (total number of tablets of tramadol)
Measured: The day of procedure up to 6 months
Steps counts
Activity levels will be continuously monitored for 3 days using smartwatch technology. Metrics such as the number of steps taken will be recorded.
Measured: The day of procedure up to 3 days
Quality of sleep
Sleep duration will be continuously monitored for 3 days using smartwatch technology.
Measured: The day of procedure up to day 3
EIFEL score
The EIFEL questionnaireis a 24-item self-administered questionnaire, adapted from the Roland and Morris Disability Questionnaire, used to assess the functional impact of low back pain.
For each of the 24 statements, the patient must tick the box if the statement corresponds to their current situation. If the patient is bedridden due to back pain, they must tick the specific box provided before the 24 statements and stop completing the questionnaire. The total score is calculated by summing the number of boxes ticked. A higher total score reflects a greater functional impairment related to low back pain
Measured: on day 3
WOMAC scores
The WOMAC questionnaire is a self-administered questionnaire consisting of 24 items divided into three subscales: pain (5 items), stiffness (2 items) and physical Function (17 items). Each item is scored from 0 to 4, yielding a total score ranging from 0 (no disability) to 96 (severe disability). The WOMAC provides valuable insights into the patient's pain levels, stiffness, physical function, and overall impact on daily living.
Measured: on day 14, month 3, and month 6
Quality of life SF12 Scores
The SF12 questionnaire is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12-question survey across multiple domains covering physical and mental health. Two summary measures will be obtained: the Physical Component Summary (PCS) and the Mental Component Summary (MCS) range from 0 (worst) to 100 (best) quality of life.
Measured: at month 3 and month 6
Health-related quality of life Scores
The EQ-5D-5L is a questionnaire used to measure a person's health-related quality of life. It includes five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five levels of severity. The responses form a code that describes the person's health state. It also includes a visual analogue scale (VAS) where individuals rate their overall health on a scale from 0 (worst) to 100 (best)
Measured: The day of procedure and at 6 month
Opioid misuse
The POMI questionnaire is a 6-item self-administered questionnaire designed to detect opioid misuse behaviour. Each YES answer is counted as 1 point and each NO answer is counted as 0 points. A score of 2 points or more indicates an opioid use disorder
Measured: on day 14, month 3, and month 6
Time to return to work
Tracking the time taken for patients to return to work following treatment provides valuable insights into functional recovery and rehabilitation outcomes
Measured: at month 6
Number of physiotherapy sessions
The Number of physiotherapy sessions for low back pain willbe recorded
Measured: At month 6
Number of recurrences
Number of recurrences of low back pain willbe recorded
Measured: at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Low Back Pain (NSLBP)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a prospective double-blind randomized multicenter study: ESP BLOCK Group versus CONTROL Group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434024
- Sponsor's protocol ID
- RECHMPL23_0409
- Other IDs
- 2024-511595-32-00
- Acronym
- ESP-BACK
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Acute Low Back Pain: a Prospective Double-blind Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT07434024
- Acronym / sponsor ID
- ESP-BACK / RECHMPL23_0409
- Conditions
- Non-specific Low Back Pain (NSLBP)
- Keywords
- Non-Specific low back pain ;, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 25 Feb 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.
Non-Specific low back pain (NSLB) is an important public health problem with a major economic and social impact. It is defined by the location of pain, between the lower rib margins and the lumbar vertebrae. Medical management of Non-Specific low back pain injury focuses on reducing pain and its consequences. Nowadays, no strategy has shown optimal effectiveness to improve outcome substantially. The ultrasound-guided erector spinae plane block (ESPB) is a well-known intermuscular compartment block. In the absence of red flag signs, ESPB can be performed for low back pain to reduce pain, decrease opiate requirements and limit emergency admissions for refractory pain. This study aims to evaluate the impact of the ESPB in patients suffering from NSLB.
Detailed description
The study is a multicenter randomized clinical trial. The patients are recruited on the day of admission in the emergency department for Non-Specific low back pain.They are randomly assigned to receive either regional anesthesia with a local anesthetic (ESP BLOCK Group) or placebo (CONTROL Group). The primary objective is to evaluate whether the ESPB is an effective treatment for patients with NSLB pain, by reducing pain and allowing immediate mobility. The secondary objectives of this study are multidimensional and aim to compare patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs), as well as clinical and economic outcomes, over a six-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The study is a prospective double-blind randomized multicenter study: ESP BLOCK Group versus CONTROL Group
| Arm | Type | Receives |
|---|---|---|
| Experimental group (ESPB) | Experimental | Procedure: Erector Spinae Plane Block with local anestheticA single injection will be performed at the erector spinae plane site, 20 ml of ropivacaine 0.2% then 8 mg of dexamethasone (2 ml) will be administered sequentially through the same needle using two separate syringes in order to prevent the risk of precipitation between the two solutions. The injection will be performed unilaterally or bilaterally as per the randomization stratification |
| Control group (placebo) | Placebo comparator | Procedure: Erector Spinae Plane Block with isotonic salineA single injection of 22 ml isotonic saline solution will be performed at the same anatomical site as the experimental group. To maintain the double-blind design, the saline solution will be administered sequentially through the same needle using two separate syringes (20 mL + 2 mL). The injection will also be performed unilaterally or bilaterally, according to the randomization stratification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (≥ 18 years);
- Non-specific low back pain (≤ 5 days);
- Pain score (VAS) ≥ 5 (during mobilization);
- Inability to walk easily (failure of the "Get Up and Go" test in less than 20 seconds).
Key exclusion criteria (26 listed)
- Low back pain of known specific origin: spine surgery, spine trauma, discal hernia, facet joint, radicular (sciatica, cruralgia, meralgia paresthetica), muscle pain, cancer-related or rheumatological disease;
- Referred or chronic pain;
- Patients with opioids (acute or chronic pain and/or misuse);
- Contraindication to regional anaesthesia;
- Contraindication to ropivacaine, dexamethasone, sodium chloride, NSAID, paracetamol, tramadol;
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 |
|---|---|---|
| Erector Spinae Plane Block with isotonic salineUltrasound-guided erector spinae plane block performed under aseptic conditions by an experienced physician, consisting of an interfascial injection in the erector spinae plane using an isotonic saline solution. | Procedure or surgery | Control group (placebo) |
| Erector Spinae Plane Block with local anestheticUltrasound-guided erector spinae plane block performed under aseptic conditions by an experienced physician, consisting of an interfascial injection in the erector spinae plane using a local anesthetic solution. | Procedure or surgery | Experimental group (ESPB) |
Primary outcome
Rate of Success of the treatment
Time frame: 30 minutes post-procedure
The primary endpoint is the success of the treatment before hospital discharge defined by a composite criteria combining the reduction of pain on mobilization (50% decrease in pain intensity) and the validation of the "Get up and go" test (in less than 20 seconds).
13 secondary outcomes
VAS Pain assessments
Time frame: The day of procedure up to 6 months
Brief Pain Inventory (BPI) pain scores
Time frame: on day 14, month 3, and month 6
Consumption of rescue analgesics
Time frame: The day of procedure up to 6 months
Steps counts
Time frame: The day of procedure up to 3 days
Quality of sleep
Time frame: The day of procedure up to day 3
EIFEL score
Time frame: on day 3
WOMAC scores
Time frame: on day 14, month 3, and month 6
Quality of life SF12 Scores
Time frame: at month 3 and month 6
Health-related quality of life Scores
Time frame: The day of procedure and at 6 month
Opioid misuse
Time frame: on day 14, month 3, and month 6
Time to return to work
Time frame: at month 6
Number of physiotherapy sessions
Time frame: At month 6
Number of recurrences
Time frame: at month 6
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 17 Mar 2026.
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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.
Xavier Cadevila, MD PHD contact
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block with isotonic saline and Erector Spinae Plane Block with local anesthetic in people with Non-specific Low Back Pain (NSLBP), run by University Hospital, Montpellier.
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 4 inclusion and 26 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: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Sophie Bringuier, Pharm D PhD (+33467338661, s-bringuierbranchereau@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Success of the treatment (time frame: 30 minutes post-procedure). 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 17 Mar 2026.