OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Depar… (NCT06987578) | Clinical Trial Compass
CompletedNot Applicable
OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department
United States45 participantsStarted 2019-07-11
Plain-language 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 structural physical exam will be included. Patients will be excluded based upon specific exclusion criteria. After providing informed consent, patients will be randomized by block randomization to receive OMT or ibuprofen 400 mg, given orally.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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) w…
What they're measuring
1
decrease opiod use
Timeframe: 10/30/2022
2
OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department
Timeframe: 60 minutes
Trial details
NCT IDNCT06987578
SponsorSt. Joseph's Regional Medical Center, New Jersey