Clinical trial NCT03968185: Interfascial Infiltration for Acute Unspecific Low Back Pain in the Emergency Department
Official title: Interfascial Infiltration to Relieve Functional Impairment in Patients Presenting to the Emergency Department for Acute Unspecific Low Back Pain: a Prospective Comparative Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Acute
Keywords: Low back pain
Pain
Disability
Interfascial infiltration
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Emergency department / emergency room / emergency management
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* adults aged between 18 and 70 years old
* presenting to the ED for low back pain from musculoskeletal origin, with symptoms evolving for less than 6 weeks,
* a score of 3 or more in the numeric pain scale (0-10)
* a score of 5 or greater on the Rolland Morris Disability Questionary (scale 0-24, RMDQ).

Exclusion Criteria:

* Traumatic or radicular pain or low back pain from alternative etiology
* allergy to local anesthetics
* Blood coagulation disorders
* Patients for whom follow-up by telephone interview was not possible
* Patients already enrolled in the study

Primary outcomes:
measure: Improvement in functional impairment
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
measure: Improvement in functional impairment
timeFrame: 7 days
measure: improvement in pain score
timeFrame: 1 hour
measure: improvement in pain score
timeFrame: 1 day
measure: improvement in pain score as
timeFrame: 7 days
measure: Pain Medicine consumption
timeFrame: 7 days
measure: subsequent physician or other health professional visit related to low back pain
timeFrame: 7 days
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Mustapha Sebbane, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: