Patient-reported Adverse Events From Osteopathic Manipulative Treatment

A.T. Still University of Health Sciences

Status: Completed

Conditions: Osteopathic Manipulative Treatment

Treatments: Procedure: Osteopathic manipulative treatment (OMT)

Study type: Observational

Funder types: Other

Identifiers

NCT02386085

OMT Adverse Events Study

Details and patient eligibility

About

Currently, there is a significant deficiency in evidence regarding the safety of osteopathic manipulative treatments (OMT). To address this deficit, this study is designed to systematically evaluate the incidence and severity of OMT adverse events and examine the relationship of these adverse events to the technique(s) used and the body region(s) treated. The study is being conducted at the clinics of participating members of DO-Touch.NET, the only known practice-based research network (PBRN) focused on osteopathic manual medicine research. Eligible patients who receive OMT at one of the participating clinics will be asked to complete either a paper or online survey regarding any adverse events they experience within 1, 3, and 7 days following their treatment. Information regarding their diagnoses, which osteopathic techniques were used in their OMT, and which body regions were treated will be obtained from participant medical records. This data will be used to answer the following research questions:

1. What is the incidence of adverse events from osteopathic manipulative treatment?
2. What types of adverse events occur following osteopathic manipulative treatment?
3. Are there individual osteopathic techniques in particular body regions that have higher incidences of adverse events than other techniques or body regions?
4. Is the incidence of adverse events higher for some patient conditions than others?

Enrollment: 1,303 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• received osteopathic manipulative treatment at one of participating clinics

Exclusion criteria

• unable to communicate in English, Spanish, French, German, or Portuguese

Trial design

1,303 participants in 1 patient group

Osteopathic manipulative treatment (OMT)

Description:

All participants will have received OMT to be eligible and will be followed for 1 week after treatment.

Treatment:

Procedure: Osteopathic manipulative treatment (OMT)