Patient-reported Adverse Events From Osteopathic Manipulative Treatment

Completed

• Conditions: Osteopathic Manipulative Treatment
• Interventions: Procedure: Osteopathic manipulative treatment (OMT)

• Registration Number: NCT02386085
• Lead Sponsor: A.T. Still University of Health Sciences

Brief 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-11
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1303

Inclusion Criteria

• received osteopathic manipulative treatment at one of participating clinics

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osteopathic manipulative treatment (OMT)	Osteopathic manipulative treatment (OMT)	All participants will have received OMT to be eligible and will be followed for 1 week after treatment.

Primary Outcome Measures

Name	Time	Method
Severity of adverse events related to osteopathic manipulative treatment (OMT)	Within 1 week after receiving 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.