NCT06987578

OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department

Osteopathic Manipulative Treatment vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: St. Joseph's Regional Medical Center, New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
OTHER	OMT vs. Ibruprofen	OMT vs. Standard Therapy in the Management of Acute Neck and Low Back Pain in the Emergency Department

Timeline

• Start date: 2019-07-11
• Primary completion: 2022-12-05
• Completion: 2022-12-05
• First posted: 2025-05-23
• Last updated: 2025-05-23

Locations

1 site across 1 country: United States