Effect of Osteopathic Manipulative Treatment for Patients With Chronic Headache
NCT ID: NCT01332864
Last Updated: 2013-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2011-03-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Can a Specific OMT Protocol Influence Patient Pain and Associated Analgesia Use for Primary Headache Disorders?
NCT06546462
Osteopathic Manipulative Techniques for the Treatment of Chronic Migraine Headaches
NCT04520425
Will the Use of Osteopathic Manipulative Treatments Help Alleviate Headache Pain
NCT01704625
Osteopathic Manual Therapy (OMT) and Brain Structure and Function in Primary Headache Patients: A Pilot Study
NCT06841627
Effectiveness of Osteopathic Manipulative Therapy in Paediatric Patients, With High Frequency Headache.
NCT04080258
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients will be randomly assigned to 1 of 4 groups for a specific Osteopathic Manipulative Treatment (OMT): Compression of Fourth Ventricle (CV4) only, CV4 and subject appropriate OMT, subject appropriate OMT only (no CV4), and sham (touch only). There will be 8 subjects per OMT group, making it 24 subjects altogether assigned to one of the three OMT groups, and 24 sham subjects.
Power analysis for determination of sample sizes: The investigators have no data on preliminary studies of the effect of OMT on chronic headaches, and there is only one study of the immediate effect on tension type headache patients after CV4, so power analysis is a rough estimate at this point for the one week headache symptom evaluation post OMT. From preliminary studies in this lab, the investigators can expect for 'CV4 only' 80% of participants to have significant still point objective response vs sham treatment which the investigators expect will significantly effect about 10% of the participants. There needs to be at least 16 subjects in each of two groups assessing this outcome measure, so 16 receiving CV4 and 16 sham to detect the 70% difference in still point measure. To detect differences between any OMT and sham, since there are three groups receiving OMT of some type, when the investigators consider how many in each of these three groups vs the sham group, the investigators figured 8 per each OMT group, of which 2 are CV4 (thus 16 get CV4), making it 24 subjects in the combined OMT groups. Therefore, the investigators need 24 sham subjects to make it equal numbers for balanced analysis (OMT vs sham), and to detect differences in the OMT interventions and sham interventions. Considering a possibility of 25%, or 12 subjects, not responding to the follow up survey at one week, the investigators figured recruitment of 60 subjects would ensure the investigators would have enough to make our calculations and be able to determine if there are significant differences between groups.
The investigators have no preliminary studies on the effect of OMT or sham on mood in patient with headaches, so this part of the study is an exploratory assessment and sample size calculations will be able to be performed with the data gathered from this study for subsequent studies.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OMT to the head and rest of body
OMT is the intervention that will be applied to areas of somatic dysfunction as well as to the head using a compression of the fourth ventricle (CV4) technique.
Osteopathic Manipulative Treatment (OMT)
O OMT applied to areas of somatic dysfunction other than the head region.
Light touch
Light touch will be applied to the head region for 10 minutes with the patient at rest in the supine position.
Light touch
Light touch applied to head region for 10 minutes with patient supine at rest.
OMT with CV4 to head
OMT is the intervention using the CV4 technique to the head region for 10 minutes with patient at rest.
Osteopathic Manipulative Treatment (OMT)
O OMT applied to areas of somatic dysfunction other than the head region.
OMT to the body except the head region
OMT is the intervention that will be applied to areas of somatic dysfunction in any region except the head.
Osteopathic Manipulative Treatment (OMT)
O OMT applied to areas of somatic dysfunction other than the head region.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Osteopathic Manipulative Treatment (OMT)
O OMT applied to areas of somatic dysfunction other than the head region.
Light touch
Light touch applied to head region for 10 minutes with patient supine at rest.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* brain disease or pathology
* seizure disorder
* using beta or alpha blocker medications
* allergy to sticky tape used to affix leads to skin
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Western University of Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michael Seffinger
Principal Investigator, Associate Professor and Chair of Dept. of NMM/OMM
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael A. Seffinger, D.O.
Role: PRINCIPAL_INVESTIGATOR
Western University of Health Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Western University of Health Sciences
Pomona, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Western University web site
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CV4OMTHA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.