- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04129437
Acute Low Back Pain in the Emergency Department Treated With Osteopathic Manipulative Treatment Versus NSAIDs
Osteopathic Manipulative Treatment Compared to Ibuprofen for the Treatment of Acute Low Back Pain in the Emergency Department: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this study is to describe the efficacy of Osteopathic Manipulative Treatment (OMT) compared to NSAIDs in decreasing pain in adults with acute low back pain in the emergency department (ED). This study would provide an additional novel adjunct for pain management of painful procedures in the emergency department. Currently in the emergency department the complaint of low back pain comprises 4.4% of visits annually and is an area of patient dissatisfaction surrounding the pain management.
The primary aims of this project will be measure the level of pain pre and post procedure in adults receiving ibuprofen (NSAID), OMT, or OMT/ibuprofen for low back pain. Secondary aims include patient and physician post procedure satisfaction scores, length of stay in ED.
AIM 1: Measure the level of pain pre and post procedures in adults receiving ibuprofen, OMT, or OMT/Ibuprofen. Hypothesis: The level of pain for patients receiving OMT will be decreased to a greater extent that those receiving only NSAIDs for low back pain.
AIM2: Measure the patient and physician satisfaction with the adjunct of OMT in regard to ability to manage pain based on satisfaction scores from questionnaire. Hypothesis: There will be greater satisfaction in the patients receiving OMT and OMT/NSAIDs than those receiving only OMT alone.
This study will be a prospective, randomized- controlled trial of patients with acute low back pain in the ED of an urban, tertiary, academic medical center. Subjects will be randomized to one of three groups: Ibuprofen (800 mg), Ibuprofen (800 mg)/OMT, or OMT only for the treatment of acute low back pain
Recruitment Methods
The research associates as well as the health care team (both residents and attending physicians) will screen patients who present to the ED with the chief complaint of back pain and may qualify for the study. Research associates will use the electronic medical record for screening, and they will be in charge of informed consent, enrollment, as well as data collection. The research study team (osteopathic emergency physicians) will be in charge of performing the OMT.
Procedures Involved in the Research
Initial medical assessment will be made in accordance with established clinical procedures, including the history, physical examination, and vital signs. If by clinical assessment the patient meets eligibility criteria, then they will be approached by a research associate for enrollment in the study and will obtain informed consent.
After informed consent, the patient will fill out a pre intervention 100 mm VAS baseline pain scale. The patient will be randomized to one of the three treatment arms; NSAID (ibuprofen), OMT/NSAID (ibuprofen), or OMT alone by using a randomization scheme generated using the web site Randomization.com (http://www.randomization.com).
Once randomized, subjects in the NSAID arm will be assessed using a VAS prior to medication administration. They will then be given 800 mg of ibuprofen and subjects' pain will be assessed using the VAS at 45 minutes after NSAID administration. Subjects in the NSAID/OMT arm will be assessed using a VAS prior to medication administration and OMT. They will then be given 800 mg of ibuprofen and within 10 minutes will receive OMT. The subject's pain will be assessed using the VAS at 45 minutes after NSAID administration and completion of OMT. The OMT only arm will be assessed using a VAS prior to any OMT. OMT will then be performed and subjects' pain will be assessed using the VAS at 45 minutes after OMT is completed. The method of OMT will be left to the discretion of the treating physician, but will be recorded in the data collection sheet.
The subject's clinical data (refer to data management) will be entered into a standardized data collection form. Study will end 45-60 minutes after randomized intervention. Once the procedure is complete subjects will fill out a post procedure satisfaction questionnaire. The physician will also fill out a post procedure questionnaire.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Megan Stobart-Gallagher, DO
- Phone Number: 985-630-0193
- Email: megan.stobart-gallagher@jefferson.edu
Study Contact Backup
- Name: Joseph Herres, DO
- Phone Number: 215-456-6666
- Email: joseph.herres@jefferson.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19147
- Recruiting
- AEHN
-
Contact:
- Beth Lynch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients 18 years of age or older with the chief complaint of acute low back pain defined as symptom duration no longer than four weeks prior to ED presentation and having clinical findings of somatic dysfunction (muscle edema, erythema, bogginess, hypertonic muscles, asymmetry of tissue, pain with movement, severe/sharp tenderness).
Exclusion Criteria:
- Patients will be excluded if they previously participated in the study, history of gastrointestinal bleed, allergies to NSAIDs, NSAID use 4 hours prior to arrival, history of or concern for spinal column fracture, current diagnosis of active malignancy or metastatic cancer, open skin wounds at the treatment location site, patients with neurological deficits related to acute back pain, pregnant women, individuals unable to take oral medications, temperature >38C, prisoners, those unable to consent, subjects under police custody, nursing home residents, non-English speaking patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: NSAID
Ibuprofen, 800 mg, one time dose
|
Weight based ibuprofen dosing
Other Names:
|
ACTIVE_COMPARATOR: OMT/NSAID
Ibuprofen, 800 mg, one time dose
|
Weight based ibuprofen dosing
Other Names:
Low velocity osteopathic manipulative treatment
Other Names:
|
ACTIVE_COMPARATOR: OMT alone
low velocity osteopathic manipulative medicine
|
Low velocity osteopathic manipulative treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score
Time Frame: 45 minutes
|
Difference in pain score before and after treatment using a Visual Analog Scale (VAS) scale (minimum 1, maximum 10, 10 being the worst)
|
45 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction
Time Frame: 45 minutes
|
Patient satisfaction immediately following treatment with questionnaire
|
45 minutes
|
Physician Satisfaction
Time Frame: 45 minutes
|
Physician satisfaction immediately following treatment with questionnaire
|
45 minutes
|
Collaborators and Investigators
Investigators
- Study Director: Joseph Herres, DO, Einstein Healthcare Network
- Principal Investigator: Megan Stobart-Gallagher, DO, Einstein Healthcare Network
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Disease Attributes
- Emergencies
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
Other Study ID Numbers
- IRB2019172
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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