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| Name | Class |
|---|---|
| American Osteopathic Association | OTHER |
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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.
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 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.
A unique patient code will be given to each patient to protect their privacy. A baseline pain score of an 11-point numeric rating scale (NRS-11) will be documented prior to the intervention. The OMT study group will receive 5 minutes of OMT treatment consisting of either or both myofascial release and muscle energy. The control group will only receive ibuprofen 400 mg in a single oral dose. At 30 and 60 minutes post intervention both groups will be asked to score their pain on the 11-point NRS scale from 0 to 10. At 60 minutes, each patient will also be asked to evaluate their perceived pain reduction on the 5-point pain reduction scale (PRS-5). A pain reduction of 50% or greater, on the NRS-11 scale, will be considered clinically significant. Additionally patients will be asked to assess whether they experienced any significant side effects, such as nausea, vomiting, epigastric pain, dizziness or worsening muscle soreness. If the patient's pain is not controlled by 60 minutes, patients will be offered rescue analgesia. The choice of analgesic will be left to the discretion of the provider, but will be recorded for analysis. Lastly, patient satisfaction and likability of treatment will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMT only | Other | THE OMT study group will receive 5 minutes of OMT treatment consisting of either or both myofascial release and muscle energy |
|
| ibuprofen or placebo | Placebo Comparator | The control group will only receive ibuprofen 400mg in a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMT vs. Ibruprofen | Other | OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department |
|
| Measure | Description | Time Frame |
|---|---|---|
| decrease opiod use | 10/30/2022 | |
| OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department | 50% change in pain score on the NRS-11 pain scale, from time of randomization to 60 minutes post-randomization | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Failure to sign consent Focal neurological deficit (motor or sensory), or paresthesia
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| Name | Affiliation | Role |
|---|---|---|
| Loretta Hall, MBHA | St. Joseph's University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's University Medical Cener | Paterson | New Jersey | 07503 | United States |
A unique code will replace a subject identifiers
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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block randomization OMT vs Standard treatment
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| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |