Will the Use of Osteopathic Manipulative Treatments Help Alleviate Headache Pain
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 11, 2012
October 1, 2012
11 months
September 19, 2012
October 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Headache Pain as Measured by a VAS
The primary outcome will be the change in pain before and immediately after intervention as measured by a 100 mm visual analog scale (VAS) for pain in patients with headaches that meet the inclusion criteria.
Immediately before and after intervention (less than 30 minutes)
Study Arms (2)
Osteopathic Manipulative Treatment
EXPERIMENTALThe 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 Osteopathic Manipulative Treatment
SHAM COMPARATORThe 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
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 sham group will receive 3 sham treatments.
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Good Samaritan Hospital Medical Center
West Islip, New York, 11795, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Genevieve McGerald, DO
Good Samaritan Hospital Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2012
First Posted
October 11, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 11, 2012
Record last verified: 2012-10