Patient-reported Adverse Events From Osteopathic Manipulative Treatment

Osteopathic Manipulative Treatment Clinical Trial

Official title:

Patient-reported Adverse Events From Osteopathic Manipulative Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386085
• Other study ID #: OMT Adverse Events Study
• Status: Completed
• Start date: February 2015
• Est. completion date: August 2017

Study information

• Verified date: April 2019
• Source: A.T. Still University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1303
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• received osteopathic manipulative treatment at one of participating clinics

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Osteopathic Manipulative Treatment

Intervention

Procedure:
• Osteopathic manipulative treatment (OMT)
OMT will be provided as part of the patient's health care, prior to enrollment in the study. All participants would have received the same intervention (OMT) if they had not enrolled in the study.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
A.T. Still University of Health Sciences	A.T. Still Research Institute, American Academy of Osteopathy, DO-Touch.NET

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of adverse events related to osteopathic manipulative treatment (OMT)	Data from surveys completed 24 hours, 72 hours, and 1 week after receiving OMT will be used to determine the severity, duration, and onset of symptoms/complaints experienced by participants. The 24- and 72-hour surveys assess the patient-reported severity, duration, and location of potential adverse events, as well as the existence and severity of these symptoms within the week prior to treatment and the participant's assessment of whether the symptom/complaint was related to the OMT they received. The 1-week survey will follow-up on symptoms/complaints reported on the 72-hour survey and whether participants have sought follow-up or urgent care, visited the emergency room, or been hospitalized during the week following OMT.	Within 1 week after receiving OMT

External Links

•   Click here for more information about this study: Patient-reported Adverse Events from Osteopathic Manipulative Treatment