Interfascial Infiltration for Acute Unspecific Low Back Pain in the Emergency Department

Completed

• Conditions: Acute; Low Back Pain
• Interventions: Other: Interfascial infiltration; Other: Standard medical treatment

• Registration Number: NCT03968185
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-25
• Status Verified: 2019-05
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Last Update Submitted: 2019-06-07
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interfascial infiltration	Interfascial infiltration	Injection of L-bupivacaine (50 mg) and dexamethasone (4 mg) in the interfascial space under ultrasound guidance.
Standard medical treatment	Standard medical treatment	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.

Primary Outcome Measures

Name	Time	Method
Improvement in functional impairment	1 day	Improvement in functional impairment as measured on the Roland-Morris Disability Questionnaire (RMQD), ranging from 0 no functional impairment to 24 severe disability

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France