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

NCT03968185 | Completed

• 1 other identifier: RECHMPL19_0129
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Other Outcomes (6)

• Improvement in functional impairment

  7 days

• improvement in pain score

  1 hour

• improvement in pain score

  1 day

Study Arms (2)

Interfascial infiltration

Injection of L-bupivacaine (50 mg) and dexamethasone (4 mg) in the interfascial space under ultrasound guidance.

Other: Interfascial infiltration

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.

Other: Standard medical treatment

Interventions

Interfascial infiltration OTHER

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

Interfascial infiltration

Standard medical treatment OTHER

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

Standard medical treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Low Back Pain; Pain; Emergencies

Interventions

Analgesics; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Narcotics; Central Nervous System Depressants

Study Officials

• Mustapha Sebbane, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: April 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 25, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-05

Locations

FR (1)