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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Acute
Low Back Pain

Treatments

Other: Interfascial infiltration
Other: Standard medical treatment

Study type

Observational

Funder types

Other

Identifiers

NCT03968185
RECHMPL19_0129

Details and patient eligibility

About

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

Full 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

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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