Clinical trial NCT01332864: Effect of Osteopathic Manipulative Treatment for Patients With Chronic Headache
Official title: Physiological and Behavioral Effects of Osteopathic Manipulative Treatment on Patients With Chronic Headache: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Headache
Cephalgia
Migraine
Keywords: headache
migraine
cephalgia
osteopathic manipulative treatment
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
First posted: 2011-04-11
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Participants with chronic or recurrent headache, unrelated to any known pathology or disease, will be randomly assigned to one of four interventions: Osteopathic manipulation of the body other than the head, osteopathic manipulation of the head, osteopathic manipulation of the head and rest of the body, or light touch on the head only but no manipulation. Measurements of heart rate and blood pressure variability, peripheral blood flow, and behavioral changes, such as mood, pain duration, intensity and frequency will be assessed.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Head pain frequency
timeFrame: one week after intervention
Secondary outcomes:
measure: Head pain intensity
timeFrame: one week
measure: Head pain duration
timeFrame: one week
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
Study officials:
affiliation: Western University of Health Sciences
name: Michael A. Seffinger, D.O.
role: PRINCIPAL_INVESTIGATOR
References: