Status:
COMPLETED
OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department
Lead Sponsor:
St. Joseph's Regional Medical Center, New Jersey
Collaborating Sponsors:
American Osteopathic Association
Conditions:
Acute Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Patients 18 to 65 years old who present within 72 hours of onset pain will be considered for study enrollment. Patients with the acute musculoskeletal low back or neck pain based on ED history and str...
Detailed Description
Patients 18 to 65 years old who present withinj 72 hours of onset pain will be considered for study enrollment. Patients with acute musculoskeletal low back or neck pain based on ED history and struct...
Eligibility Criteria
Inclusion
- Patients 18 to 65 years old who present within 72 hours of onset pain will be considered for study enrollment. Patients with acute musculoskeletal low back or neck pain based on ED history and structural physical exam will be included, provided they sign the informed consent.
Exclusion
- Failure to sign consent Focal neurological deficit (motor or sensory), or paresthesia
- Severe osteoporosis
- History of peptic ulcer disease
- Presentation requiring cardiac monitoring
- Fracture, dislocation, or joint instability at the area of symptoms
- Presentation after traumatic injury requiring C-collar placement prior to or subsequent to arrival
- Cancer or malignancy of the head, neck, chest or back
- Allergy to aspirin or nonsteroidal anti-inflammatory drugs
- Cellulitis (skin infection) at the treatment site
- Pregnancy or currently breastfeeding
- History of renal impairment
- Cervical or lumbar radiculopathy
- Active illicit drug abuse or chronic alcohol use
- Chronic pain syndrome
- Daily opioid use
- Use of aspirin daily
- Use of antiplatelet or anticoagulant medications (clopidogrel, warfarin, dabigatran rivaroxaban, apixaban or other similar medications)
- Glasgow Coma Scale (GCS) less than 15 or altered mental status
- Prisoners presenting in police custody
- Use of any non-steroidal antiplatelet medications (NSAIDS) or administration of any non-pharmacological manipulation (Physical Therapy or OMT) within six hours prior to presentation.
Key Trial Info
Start Date :
July 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06987578
Start Date
July 11 2019
End Date
December 5 2022
Last Update
May 23 2025
Active Locations (1)
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1
St. Joseph's University Medical Cener
Paterson, New Jersey, United States, 07503