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出境医 / 临床实验 / Interfascial Infiltration for Acute Unspecific Low Back Pain in the Emergency Department (PreSosLumbago)

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

Study Description
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


Condition or disease Intervention/treatment
Low Back Pain Acute Other: Interfascial infiltration Other: 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 Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Retrospective
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
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 25, 2019
Arms and Interventions
Group/Cohort Intervention/treatment
Interfascial infiltration
Injection of L-bupivacaine (50 mg) and dexamethasone (4 mg) in the interfascial space under ultrasound guidance.
Other: Interfascial infiltration

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 Name: Interfascial injection

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

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 Name: Analgesic, level I and II, opioid

Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
Contacts and Locations

Locations
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France
Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Mustapha Sebbane, MD, PhD University Hospital, Montpellier
Tracking Information
First Submitted Date May 27, 2019
First Posted Date May 30, 2019
Last Update Posted Date June 11, 2019
Actual Study Start Date April 1, 2017
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2019)
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
Original Primary Outcome Measures
 (submitted: May 27, 2019)
Improvement in functional impairment [ Time Frame: 1 day ]
Improvement in functional impairment as measured on the 24-item RMDQ score
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2019)
  • 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
  • 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)
  • 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)
  • 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)
  • Pain Medicine consumption [ Time Frame: 7 days ]
    Pain Medicine consumption within a week from ED management.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: May 27, 2019)
  • Improvement in functional impairment [ Time Frame: 7 days ]
    Improvement in functional impairment as measured on the 24-item RMDQ score
  • improvement in pain score [ Time Frame: 1 hour ]
    improvement in pain score as measured on a numeric pain scale (ranging from 0-10)
  • improvement in pain score [ Time Frame: 1 day ]
    improvement in pain score as measured on a numeric pain scale
  • improvement in pain score as [ Time Frame: 7 days ]
    improvement in pain score as measured on a numeric pain scale
  • Pain Medicine consumption [ Time Frame: 7 days ]
    Pain Medicine consumption within a week from ED management.
  • 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.
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Low Back Pain
  • Acute
Intervention
  • Other: Interfascial infiltration

    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 Name: Interfascial injection
  • Other: 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.

    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 Name: Analgesic, level I and II, opioid
Study Groups/Cohorts
  • Interfascial infiltration
    Injection of L-bupivacaine (50 mg) and dexamethasone (4 mg) in the interfascial space under ultrasound guidance.
    Intervention: 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.
    Intervention: Other: Standard medical treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 27, 2019)
30
Original Actual Enrollment Same as current
Actual Study Completion Date February 25, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03968185
Other Study ID Numbers RECHMPL19_0129
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: NC
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
Investigators
Principal Investigator: Mustapha Sebbane, MD, PhD University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date May 2019