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

NCT06987578 | Completed

• 1 other identifier: PR#19-025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Pain

Keywords

musculoskeletal pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

OMT only

OTHER

THE OMT study group will receive 5 minutes of OMT treatment consisting of either or both myofascial release and muscle energy

Other: OMT vs. Ibruprofen

ibuprofen or placebo

PLACEBO COMPARATOR

The control group will only receive ibuprofen 400mg in a single dose

Other: OMT vs. Ibruprofen

Interventions

OMT vs. Ibruprofen OTHER

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

OMT only; ibuprofen or placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Regional Medical Center, New Jersey: lead
• American Osteopathic Association: collaborator

Study Sites (1)

St. Joseph's University Medical Cener

Paterson, New Jersey, 07503, United States

Location

MeSH Terms

Conditions

Acute Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Loretta Hall, MBHA

  St. Joseph's University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: block randomization OMT vs Standard treatment

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: May 23, 2025
• Study Start: July 11, 2019
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)