An observational study in Low Back Pain and Acute, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-11.
Sponsored by University Hospital, Montpellier · Observational
Pain relief and functional impairment have been shown to remain poor to moderate over weeks after emergency department discharge, in patients who seek ED management for acute nontraumatic, nonradicular low back pain.
The investigators made the hypothesis that ultrasound-guided interfascial infiltration of local anesthesics and corticoid is efficient and safe in treating patients presenting to the ED with acute non specific low back pain. The investigators aimed to compare early and short term functional impairment and pain relief one day and 1 week after interfacial infiltration, as compared to standard medical treatment
This is a single center observational feasibility study enrolling ED patients presenting with acute unspecific low back pain.
Ultrasound-guided interfascial infiltration is proposed to eligible patients presenting to our ED with low back pain and disability, as part of routine care. Patients receive standard medical treatment if they refuse interfascial infiltration or in case of absence or unavailability of a trained operator.
Patients were followed-up at 1 day and 7-days pots ED discharge by telephone interview conducted by an independent member of our research team not involved in patient's management
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 357 observational studies indexed under Back Pain.
Browse Back Pain studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult emergency room patient as part of the usual management for non-traumatic, non-radicular, non-radicular, musculoskeletal pain with functional impotence defined by a score of 5 or higher on the EIFEL scale
Exclusion Criteria:
Injection of L-bupivacaine (50 mg) and dexamethasone (4 mg) in the interfascial space under ultrasound guidance.
Other: Interfascial infiltration
Standard medical treatment include acetaminophen, NSAIDs and muscle relaxant as first line pharmacological treatment and escalation to analgesics level II or morphine if required, as needed for low back pain, in agreement with national guidelines Route of administration (orally or iv) was let at the discretion of the attending emergency physician.
Other: Standard medical treatment
Injection of L-bupivacaine (50 mg) and dexamethasone (4 mg) in the interfascial space under ultrasound guidance. Patients were kept under surveillance for at least one hour before discharge. Patients were discharged home with a 7 day supply of acetaminophen 1000 mg orally every 6 h, ketoprofen 100 mg, orally twice a day, and muscle relaxant as needed. Patients were instructed to take tramadol 50 mg, orally every 6h as needed for low back pain, in case of insufficient relief.
Also known as: Interfascial injection
Standard medical treatment include acetaminophen, NSAIDs and muscle relaxant as first line pharmacological treatment and escalation to analgesics level II or morphine if required, as needed for low back pain, in agreement with national guidelines Route of administration (orally or iv) was let at the discretion of the attending emergency physician. Patients were kept under surveillance for one hour before discharge. Patients were discharged home with a 7 day supply of acetaminophen 1000 mg orally every 6h, ketoprofen 100 mg, orally twice a day, and muscle relaxant as needed. Patients were instructed to take tramadol 50 mg, orally every 6h as needed for low back pain, in case of insufficient relief.
Also known as: Analgesic, level I and II, opioid
Improvement in functional impairment
Improvement in functional impairment as measured on the Roland-Morris Disability Questionnaire (RMQD), ranging from 0 no functional impairment to 24 severe disability
Time frame: 1 day
Improvement in functional impairment
Improvement in functional impairment as measured on the Roland-Morris Disability Questionnaire (RMQD), ranging from 0 no functional impairment to 24 severe disability
Time frame: 7 days
improvement in pain score
improvement in pain score as measured on a numeric pain scale (10 point- scale ranging from 0-no pain to 10-greatest pain)
Time frame: 1 hour
improvement in pain score
improvement in pain score as measured on a numeric pain scale (10 point- scale ranging from 0-no pain to 10-greatest pain)
Time frame: 1 day
improvement in pain score as
improvement in pain score as measured on a numeric pain scale (10 point- scale ranging from 0-no pain to 10-greatest pain)
Time frame: 7 days
Pain Medicine consumption
Pain Medicine consumption within a week from ED management.
Time frame: 7 days
subsequent physician or other health professional visit related to low back pain
subsequent physician or other health professional visit related to low back pain within a week from ED management.
Time frame: 7 days
Plan to share: Undecided — NC
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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier