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 |
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Low Back Pain Acute | Other: Interfascial infiltration Other: Standard medical treatment |
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 |
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 |
Group/Cohort | Intervention/treatment |
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Interfascial infiltration
Injection of L-bupivacaine (50 mg) and dexamethasone (4 mg) in the interfascial space under ultrasound guidance.
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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
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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.
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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
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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 |
Inclusion Criteria:
Exclusion Criteria:
France | |
Uh Montpellier | |
Montpellier, France, 34295 |
Principal Investigator: | Mustapha Sebbane, MD, PhD | University Hospital, Montpellier |
Tracking Information | |||||
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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 |
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
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Original Primary Outcome Measures |
Improvement in functional impairment [ Time Frame: 1 day ] Improvement in functional impairment as measured on the 24-item RMDQ score
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Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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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 |
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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 |
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Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Retrospective |
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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 |
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Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | University Hospital, Montpellier | ||||
Study Sponsor | University Hospital, Montpellier | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University Hospital, Montpellier | ||||
Verification Date | May 2019 |