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

Status unconfirmed · Phase 4

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID: NCT04129437
Run by: Albert Einstein Healthcare Network
People needed: 174
Starts: 2020-02-19
Expected to finish: 2023-01-01
Last updated by the study team: 2022-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

AEHN — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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