Non-specific Low Back Pain (NSLBP)
Conditions
Keywords
Non-Specific low back pain ;, Erector Spinae Plane Block
Brief 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. 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.
Interventions
PROCEDUREErector Spinae Plane Block with isotonic saline
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.
PROCEDUREErector Spinae Plane Block with local anesthetic
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.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
The study is a prospective double-blind randomized multicenter study: ESP BLOCK Group versus CONTROL Group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Success of the treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of recurrences | at month 6 | Number of recurrences of low back pain willbe recorded |
| VAS Pain assessments | The day of procedure up to 6 months | 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. |
| Brief Pain Inventory (BPI) pain scores | on day 14, month 3, and month 6 | 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) |
| Consumption of rescue analgesics | The day of procedure up to 6 months | Consumption of rescue analgesic (total number of tablets of tramadol) |
| Steps counts | The day of procedure up to 3 days | Activity levels will be continuously monitored for 3 days using smartwatch technology. Metrics such as the number of steps taken will be recorded. |
| Quality of sleep | The day of procedure up to day 3 | Sleep duration will be continuously monitored for 3 days using smartwatch technology. |
| EIFEL score | on day 3 | 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 |
| WOMAC scores | on day 14, month 3, and month 6 | 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. |
| Quality of life SF12 Scores | at month 3 and month 6 | 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. |
| Health-related quality of life Scores | The day of procedure and at 6 month | 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) |
| Opioid misuse | on day 14, month 3, and month 6 | 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 |
| Number of physiotherapy sessions | At month 6 | The Number of physiotherapy sessions for low back pain willbe recorded |
| Time to return to work | at month 6 | Tracking the time taken for patients to return to work following treatment provides valuable insights into functional recovery and rehabilitation outcomes |
Contacts
CONTACTSophie Bringuier, Pharm D PhD
CONTACTXavier Cadevila, MD PHD
Outcome results
None listed