HeadachePhase 4OMTHANCT01332864
Effect of Osteopathic Manipulative Treatment for Patients With Chronic Headache
A Phase 4 study testing Osteopathic Manipulative Treatment (OMT) and Light touch in people with Headache and Cephalgia, run by Western University of Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Osteopathic Manipulative Treatment (OMT) and Light touch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- chronic or recurrent headaches at least as often as one time per week
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western University of Health Sciences
Pomona, California, 91766
About this study
Official title: Physiological and Behavioral Effects of Osteopathic Manipulative Treatment on Patients With Chronic Headache: A Randomized Clinical Trial
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.
Read the 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.
- Being tested
- Osteopathic Manipulative Treatment (OMT), Light touch
- Keywords
- headache, migraine, cephalgia, osteopathic manipulative treatment
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment (OMT)Procedure or surgery
Also called headache; OMT; somatic dysfunction ICD-9 code 739.0
O OMT applied to areas of somatic dysfunction other than the head region.
Light touchProcedure or surgery
Also called placebo; sham
Light touch applied to head region for 10 minutes with patient supine at rest.
| Study group | Role | What they receive |
|---|---|---|
| OMT to the head and rest of body | Active comparator | 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. Receives: Procedure: Osteopathic Manipulative Treatment (OMT) |
| Light touch | Placebo comparator | Light touch will be applied to the head region for 10 minutes with the patient at rest in the supine position. Receives: Procedure: Light touch |
| OMT with CV4 to head | Experimental | OMT is the intervention using the CV4 technique to the head region for 10 minutes with patient at rest. Receives: Procedure: Osteopathic Manipulative Treatment (OMT) |
| OMT to the body except the head region | Active comparator | OMT is the intervention that will be applied to areas of somatic dysfunction in any region except the head. Receives: Procedure: Osteopathic Manipulative Treatment (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week after intervention
Secondary outcomes (2)
Head pain intensity
one week after intervention participants will be contacted and asked to rate the intensity of their headaches after the intervention.
Measured: one week
Head pain duration
one week after the intervention participants will be contacted and asked the duration of the headaches.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seffinger, Western University of Health Sciences
- Investigators
- Michael A. Seffinger, D.O., Principal investigator, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332864
- Sponsor's protocol ID
- CV4OMTHA
- Acronym
- OMTHA
- Status last verified
- Feb 2013
- First submitted
- 4 Apr 2011
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Behavioral Effects of Osteopathic Manipulative Treatment on Patients With Chronic Headache: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01332864
- Acronym / sponsor ID
- OMTHA / CV4OMTHA
- Keywords
- headache, migraine, cephalgia, osteopathic manipulative treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OMT to the head and rest of body | Active comparator | Procedure: Osteopathic Manipulative Treatment (OMT)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. |
| Light touch | Placebo comparator | Procedure: Light touchLight touch will be applied to the head region for 10 minutes with the patient at rest in the supine position. |
| OMT with CV4 to head | Experimental | Procedure: Osteopathic Manipulative Treatment (OMT)OMT is the intervention using the CV4 technique to the head region for 10 minutes with patient at rest. |
| OMT to the body except the head region | Active comparator | Procedure: Osteopathic Manipulative Treatment (OMT)OMT is the intervention that will be applied to areas of somatic dysfunction in any region except the head. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- chronic or recurrent headaches at least as often as one time per week
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT)Also: headache; OMT; somatic dysfunction ICD-9 code 739.0O OMT applied to areas of somatic dysfunction other than the head region. | Procedure or surgery | OMT to the body except the head region, OMT to the head and rest of body, OMT with CV4 to head |
| Light touchAlso: placebo; shamLight touch applied to head region for 10 minutes with patient supine at rest. | Procedure or surgery | Light touch |
Primary outcome
Head pain frequency
Time frame: one week after intervention
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.
2 secondary outcomes
Head pain intensity
Time frame: one week
Head pain duration
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
- Western University web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A. Seffinger, D.O. principal investigator
Western University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Osteopathic Manipulative Treatment (OMT) and Light touch in people with Headache and Cephalgia, run by Western University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head pain frequency (time frame: one week after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.