Acute Low Back Pain in the Emergency Department Treated With Osteopathic Manipulative Treatment Versus NSAIDs

NCT04129437 | Unknown Phase 4 FDA Drug

• 1 other identifier: IRB2019172
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Acute low back pain is the fifth most common presenting complaint to the emergency department, accounting for approximately 4.4% of annual visits. The treatment for acute low back pain is often NSAIDs or other analgesic medications. Osteopathic Manipulative Treatment (OMT) has been shown to be an effective treatment modality for acute low back pain, however, it's use in the emergency department setting is not well described. The adjunct of OMT has the potential to increase patient satisfaction, decrease length of stay and decrease the number of unnecessary prescription medications. We plan to investigate the use of OMT in the setting of acute complaints of low back pain in comparison to the use of nonsteroidal anti-inflammatory drugs (NSAIDs) as primary treatment modality. The study will be a non-blinded randomized-control trial and will take place in an academic tertiary care center in urban Philadelphia, PA over an approximate one-year timespan. We will utilize osteopathic-trained attending and resident physicians to perform the manipulation. Patients will be randomized into one of three treatment groups: appropriately dosed NSAID therapy alone, OMT in addition to NSAID therapy, or OMT alone. The primary outcome will be the difference in pain score before and after treatment using a VAS scale. Secondary outcomes will include patient and physician satisfaction immediately following treatment. Results will be shared by means of publication to the osteopathic and allopathic communities.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain score

  Difference in pain score before and after treatment using a Visual Analog Scale (VAS) scale (minimum 1, maximum 10, 10 being the worst)

  45 minutes

Secondary Outcomes (2)

• Patient Satisfaction

  45 minutes

• Physician Satisfaction

  45 minutes

Study Arms (3)

NSAID

ACTIVE COMPARATOR

Ibuprofen, 800 mg, one time dose

Drug: Ibuprofen

OMT/NSAID

ACTIVE COMPARATOR

Ibuprofen, 800 mg, one time dose

Drug: Ibuprofen; Procedure: Osteopathic manipulative treatment

OMT alone

ACTIVE COMPARATOR

low velocity osteopathic manipulative medicine

Procedure: Osteopathic manipulative treatment

Interventions

Ibuprofen DRUG

Weight based ibuprofen dosing

Also known as: Motrin, Advil

NSAID; OMT/NSAID

Osteopathic manipulative treatment PROCEDURE

Low velocity osteopathic manipulative treatment

Also known as: OMT, OMM

OMT alone; OMT/NSAID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 years of age or older with the chief complaint of acute low back pain defined as symptom duration no longer than four weeks prior to ED presentation and having clinical findings of somatic dysfunction (muscle edema, erythema, bogginess, hypertonic muscles, asymmetry of tissue, pain with movement, severe/sharp tenderness).

You may not qualify if:

• Patients will be excluded if they previously participated in the study, history of gastrointestinal bleed, allergies to NSAIDs, NSAID use 4 hours prior to arrival, history of or concern for spinal column fracture, current diagnosis of active malignancy or metastatic cancer, open skin wounds at the treatment location site, patients with neurological deficits related to acute back pain, pregnant women, individuals unable to take oral medications, temperature \>38C, prisoners, those unable to consent, subjects under police custody, nursing home residents, non-English speaking patients.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

AEHN

Philadelphia, Pennsylvania, 19147, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Ibuprofen; Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Joseph Herres, DO

  Einstein Healthcare Network

  STUDY DIRECTOR

• Megan Stobart-Gallagher, DO

  Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Stobart-Gallagher, DO

CONTACT

985-630-0193; megan.stobart-gallagher@jefferson.edu

Joseph Herres, DO

CONTACT

215-456-6666; joseph.herres@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 16, 2019
• Study Start: February 19, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

US (1)