Effect of Osteopathic Manipulative Treatment for Patients With Chronic Headache

Migraine Clinical Trial

— OMTHA  

Official title:

Physiological and Behavioral Effects of Osteopathic Manipulative Treatment on Patients With Chronic Headache: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332864
• Other study ID #: CV4OMTHA
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2011
• Last updated: February 11, 2013
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: Western University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cephalgia
• Headache
• Migraine

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Western University of Health Sciences	Pomona	California

Sponsors (1)

Lead Sponsor	Collaborator
Western University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Head pain frequency	seven days after the intervention participants will be called by telephone and asked whether they had their usual headache in the week following the intervention.	one week after intervention	No
Secondary	Head pain intensity	one week after intervention participants will be contacted and asked to rate the intensity of their headaches after the intervention.	one week	No
Secondary	Head pain duration	one week after the intervention participants will be contacted and asked the duration of the headaches.	one week	No

External Links

•   Western University web site