Recruiting

Osteopathic Manipulative Treatments

Sponsor:

Good Samaritan Hospital Medical Center, New York

Code:

NCT01704625

Conditions

Headache

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Osteopathic Manipulative Treatment

Sham Osteopathic Manipulative Treatment

Study Details

Brief summary:

PURPOSE The purpose of this research is to determine whether osteopathic manipulative therapy (OMT) is a useful adjunct in evaluation and treatment of headaches.

PROCEDURES If a practitioner determines that a patient has a significant headache he/she may order tests. He/ She may give the patient medications to treat the headache.

The investigators will also ask permission to evaluate and treat the headache using osteopathic evaluation and Osteopathic Manipulative Treatment (OMT). The bedside evaluation and treatment will be performed by an emergency medicine resident. Osteopathic evaluation and OMT is not standard of care for this condition. The investigators also may call the patient in 7 days to see how they are doing.

The investigators wish to see if emergency medicine physicians can use osteopathic evaluation and OMT to reliably treat headaches. The results of the examination and treatment will be recorded, but will not be used to change treatment or to change additional tests. The investigators wish to see whether in the future they can use OMT in certain cases instead of or in conjunction with medications. The investigators plan on asking 50 patients to participate.

Conditions

Headache

Study ID

NCT01704625

Start date

Jan, 2012

Status verified date

Oct, 2012

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

Patients will be triaged to the appropriate part of the Emergency Department in the usual fashion. A healthcare provider will evaluate the patient and if the patient's chief complaint is headache the provider will determine if they are a candidate for the study utilizing exclusion criteria for the study -

Exclusion Criteria:

Exclusion Criteria for the Study

Temperature 100.4 or greater

Healthcare provider suspects meningitis, brain abscess, encephalitis

Altered mental status

History of trauma

Cyclic vomiting

Abdominal migraines

Analgesic medication taken prior to treatment within an hour

Providing physician suspects intracranial hemorrhage

Focal deficits or other neurological abnormalities that lead providing physician to suspect a pathologic process in which osteopathic treatment would not be safe for the patient

Providing physician feels osteopathic treatment would not be safe for the patient

-

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Osteopathic Manipulative Treatment

The osteopathic treatment group will have performed on them 3 standardized osteopathic manipulative treatments. If at any time the patient is unable to tolerate a treatment secondary to pain that particular study will be stopped. If the patient's nurse enters the room with medication, the study will be stopped and patient will not be included in the study. At no time will the patient's medical treatment in the emergency department be delayed to perform OMT

sham comparator: Sham Osteopathic Manipulative Treatment

The sham group will receive 3 sham treatments. If at any time the patient is unable to tolerate a treatment secondary to pain that particular study will be stopped. If the patient's nurse enters the room with medication, the study will be stopped and patient will not be included in the study. At no time will the patient's medical treatment in the emergency department be delayed to perform OMT.

Interventions

Osteopathic Manipulative Treatment

The investigators wish to see if emergency medicine physicians can use osteopathic evaluation and OMT to reliably treat headaches. The results of the examination and treatment will be recorded, but will not be used to change treatment or to change additional tests.

Sham Osteopathic Manipulative Treatment

The sham group will receive 3 sham treatments.

Primary outcome measure

  • Headache Pain as Measured by a VAS [ Time Frame: Immediately before and after intervention (less than 30 minutes) ]

Central Contacts and Locations

Central contacts

Ronald Dvorkin, MD

631-376-4094ronald.dvorkin@chsli.org

Genevieve McGerald, DO

631-376-4094genevieve.mcgerald@chsli.org

Locations

Good Samaritan Hospital Medical Center

Recruiting

West Islip, New York, United States, 11795

Contacts

Genevieve McGerald, DO

631-376-4094genevieve.mcgerald@chsli.org

Ronald Dvorkin, MD

631-376-4094ronald.dvorkin@chsli.org

Principal Investigator:

Genevieve McGerald, DO

More Information

Sponsor

Good Samaritan Hospital Medical Center, New York

Last update posted

Oct 11, 2012

Last verified

Oct, 2012

Keywords

  • pain
  • headache

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Good Samaritan Hospital Medical Center, New York on 2012-10-11.