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Completed

NCT Number: NCT03968185

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

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

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Key information

Conditions

Low Back Pain Acute Back Pain Disease Attributes Emergencies Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Interfascial injection

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.

Other names: Analgesic, level I and II, opioid

Primary outcomes

  1. Improvement in functional impairment

    Time frame: 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

Other outcomes

  1. Improvement in functional impairment

    Time frame: 7 days

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

  2. improvement in pain score

    Time frame: 1 hour

    improvement in pain score as measured on a numeric pain scale (10 point- scale ranging from 0-no pain to 10-greatest pain)

  3. improvement in pain score

    Time frame: 1 day

    improvement in pain score as measured on a numeric pain scale (10 point- scale ranging from 0-no pain to 10-greatest pain)

  4. improvement in pain score as

    Time frame: 7 days

    improvement in pain score as measured on a numeric pain scale (10 point- scale ranging from 0-no pain to 10-greatest pain)

  5. Pain Medicine consumption

    Time frame: 7 days

    Pain Medicine consumption within a week from ED management.

  6. subsequent physician or other health professional visit related to low back pain

    Time frame: 7 days

    subsequent physician or other health professional visit related to low back pain within a week from ED management.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: PreSosLumbago

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 30, 2019
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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