Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01332864
Study type Interventional
Source Western University of Health Sciences
Contact
Status Completed
Phase Phase 4
Start date March 2011
Completion date December 2012

See also
  Status Clinical Trial Phase
Completed NCT06192173 - Patent Foramen Ovale Closure in Migraine
Completed NCT05525611 - Cabergoline as a Preventive Treatment for Chronic Migraine N/A
Recruiting NCT03832998 - Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine Phase 3
Enrolling by invitation NCT04196933 - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma N/A
Not yet recruiting NCT06428838 - Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context Phase 3
Completed NCT06304675 - Manageable Environmental Factors in Migraine
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Recruiting NCT05517200 - Pilot Study for a Machine Learning Test for Migraine
Completed NCT04179474 - Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine Phase 1
Recruiting NCT04603976 - Registry for Migraine - Clinical Core Phase 4
Completed NCT03597529 - CHOCOlate MeLatonin for AdolescenT MigrainE Phase 2
Completed NCT04197349 - Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman Phase 1
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Active, not recruiting NCT05064371 - Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan Phase 3
Suspended NCT04069572 - Vibratory Stimulation for the Treatment of Chronic Pain N/A
Not yet recruiting NCT04859374 - Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach N/A
Not yet recruiting NCT03083860 - Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions. N/A
Completed NCT02905227 - A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder Phase 1
Enrolling by invitation NCT02532023 - The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients Phase 4
Completed NCT02108678 - One-Day Intervention for Depression and Impairment in Migraine Patients N/A