Recruiting

Osteopathic Manipulative Treatment vs. NSAIDs

Sponsor:

Albert Einstein Healthcare Network

Code:

NCT04129437

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ibuprofen

Osteopathic manipulative treatment

Study Details

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

Study ID

NCT04129437

Start date

Feb 19, 2020

Status verified date

Nov, 2022

Completion date

Jan, 2023

Anticipated

Primary completion date

Jan, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Design

Enrollment

174 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: NSAID

Ibuprofen, 800 mg, one time dose

active comparator: OMT/NSAID

Ibuprofen, 800 mg, one time dose

active comparator: OMT alone

low velocity osteopathic manipulative medicine

Interventions

Ibuprofen

Weight based ibuprofen dosing

Osteopathic manipulative treatment

Low velocity osteopathic manipulative treatment

Primary outcome measure

  • Pain score [ Time Frame: 45 minutes ]

Central Contacts and Locations

Central contacts

Locations

AEHN

Recruiting

Philadelphia, Pennsylvania, United States, 19147

More Information

Sponsor

Albert Einstein Healthcare Network

Last update posted

Nov 7, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Albert Einstein Healthcare Network on 2022-11-07.