Effect of Osteopathic Manipulative Treatment for Patients With Chronic Headache

Sixty subjects will be recruited to participate in the study via word of mouth and mass
email notification of employees and students at Western University of Health Sciences in
Pomona, CA.

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.

Inclusion Criteria:

- chronic or recurrent headaches at least as often as one time per week

Exclusion Criteria:

- recent head trauma

- brain disease or pathology

- seizure disorder

- using beta or alpha blocker medications

- allergy to sticky tape used to affix leads to skin