Trial Summary
What is the purpose of this trial?The purpose of this study is to see if osteopathic manipulation or light touch can reduce either or both frequency of headaches or use of pain medication. Osteopathic manipulative treatment (OMT) has been shown to help headache symptoms. The investigators like to see if regular OMT sessions can help reduce headache discomfort and also reduce use of pain medication like over-the-counter medications, migraine medications, and opioids. In this randomized controlled trial, a set sequence of OMT will be compared to light touch sham protocol. Investigators will compare participant responses to questionnaires that assess items including pain levels and reported pain medication use for the course of the study period to see if there are any shifts.
Eligibility Criteria
This trial is for individuals who frequently experience headaches and may be using pain medication, including opioids. Participants should have a history of primary headache disorders but not currently be receiving OMT. They must not have conditions that would interfere with the treatment or assessment.Inclusion Criteria
I am considered fit for osteopathic manipulative treatment by a doctor.
I am between 18 and 75 years old.
I use pain medication for headaches more than 10 times a month.
+1 more
Exclusion Criteria
I have had brain surgery or a brain-related health event like a stroke.
I have been diagnosed with a tumor.
Acute psychiatric diagnosis
+3 more
Participant Groups
The study aims to determine if regular sessions of osteopathic manipulative treatment (OMT) can reduce headache frequency or the need for pain medication compared to a sham light touch protocol in a randomized controlled setting.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Osteopathic Manipulation armExperimental Treatment1 Intervention
* All subjects receive osteopathic structural exam and screening for somatic dysfunction of the cranium, spine, sacrum, and ribs.
* The OMT arm will have the following techniques performed for the stated time to total 14 minutes.
1. Thoracic inlet release: 45 seconds maximum
2. Suboccipital release: 1 minute maximum
3. Occipito-mastoid suture release: 1 minute maximum
4. Venous sinus drainage: 1 minute maximum
5. Balanced membranous tension: 1 minute maximum
6. Compression of the 4th Ventricle (CV4): 1 minute maximum
7. Cervical soft tissue: 1 minute maximum
8. Trapezius inhibition: 45 seconds maximum
9. Bilateral rib raising: 2 minutes max (1 min per side)
10. Sacroiliac gapping: 1 minute maximum
11. Sacral rock: 1 minute maximum
12. Seated bilateral thoracic and lumbar paraspinal articulation: 2 minutes maximum
Group II: Sham Light touch armPlacebo Group1 Intervention
* All subjects receive osteopathic structural exam and screening for somatic dysfunction of the cranium, spine, sacrum, and ribs..
* The sham group will follow an established protocol of light systematic touch for the same duration as the OMT group. It consists of contacting a sequence of anatomical areas for 2 minutes each: right ankle, left knee, right hip, diaphragm, right shoulder, neck, and cranium. Total procedure time is 14 minutes.
Osteopathic Manipulative Treatment (OMT) is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Osteopathic Manipulative Treatment for:
- Carpal Tunnel Syndrome
🇪🇺 Approved in European Union as Osteopathic Manipulative Treatment for:
- Carpal Tunnel Syndrome
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Riland Academic Health Care CenterOld Westbury, NY
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Who Is Running the Clinical Trial?
New York Institute of TechnologyLead Sponsor