Headache DisordersNCT06546462
Can a Specific OMT Protocol Influence Patient Pain and Associated Analgesia Use for Primary Headache Disorders?
A study testing Osteopathic Manipulative Treatment (OMT) in people with Headache Disorders and Headache, run by New York Institute of Technology at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Headache Disorders, Headache, Analgesia
- What is being tested?
- Osteopathic Manipulative Treatment (OMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age
- takes opioids or any other pain medication for headaches more than 10 times a month (including over the counter and prescription medications for headaches).
- 3 months or greater history of headaches or migraines
- Patient able to tolerate OMT based on osteopathic physician discretion and with consideration of absolute and relative contraindications to OMT
Who cannot join
- current diagnosis of neoplasm
- history of headache secondary to trauma or concussion
- history of brain/cranial surgery, cerebral vascular events/disease (e.g., stroke, Brain arteriovenous malformation (AVM), vertebral artery disease)
- acute psychiatric diagnosis
- pregnancy
- history of substance use disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Riland Academic Health Care Center
Old Westbury, New York, 11545
About this study
Official title: Can a Specific OMT Protocol Influence Patient-reported Pain and Associated Analgesia Use for Primary Headache Disorders?
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.
Read the detailed description
The purpose of this study is to evaluate the effectiveness of osteopathic manipulative treatment protocol (OMT) or light touch protocol in reducing headache frequency and the use of pain medication for headache pain. Previous research has suggested that OMT may alleviate headache symptoms. This randomized controlled trial aims to determine whether regular OMT sessions can decrease headache discomfort and reduce the use of pain medications, including over-the-counter medications, migraine-specific treatments, and opioids. The study consists of a ten-week period, including 2 weeks of observation, 6 weeks of intervention, and 2 weeks of washout. Participants will be randomly assigned to either receive OMT or a light touch protocol. Investigators will compare questionnaires assessing quality of life and functionality scales. Pain levels and medication use will be logged daily throughout the study.
- Conditions
- Headache Disorders, Headache, Analgesia, Opioid Use, Osteopathy
- Being tested
- Osteopathic Manipulative Treatment (OMT), Sham Light touch arm
- Keywords
- Osteopathic manipulative medicine, Osteopathic manipulative treatment, Headache
- Medical subject headings
- Headache Disorders, Headache, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment (OMT)Other
The active arm will receive osteopathic manipulative treatment which is a hands-on treatment modality use to treat a variety of health concerns.
Sham Light touch armOther
Sham arm will receive a light touch sham treatment.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulation arm | Experimental | * 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 Receives: Other: Osteopathic Manipulative Treatment (OMT) |
| Sham Light touch arm | Sham comparator | * 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. Receives: Other: Sham Light touch arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain levels
The primary outcome measures will assess if consistent use of OMT for headache causes a reduction in headache pain for headache-associated discomfort. Pain will be rated on a Numeric Rating Scale (NRS) so individuals can rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).
Measured: Assessment of weekly average pain from week 1 till week 10 end of the study period
Change in analgesia use
The primary outcome measures will assess if consistent use of OMT for headache causes a reduction in headache analgesia use for headache-associated discomfort.
Measured: Assessment of weekly amount of pain medications used from week 1 till week 10 end of the study period
Secondary outcomes (3)
Change in quality of Life - Headache disability index
Secondary measures will assess any changes to physical and mental health and reduce the impact of headaches via the Headache disability index. Max score = 100. The higher the score the worse the symptoms. A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects.
Measured: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
Change in quality of Life - Headache Impact Test (HIT-6)
Secondary measures will assess any changes to physical and mental health and reduce the impact of headaches via the Headache Impact Test (HIT-6) Higher scores indicate a greater impact on your life. Score range 36-78.
Measured: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
Change in quality of Life - The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group (EQ-5DL)
Secondary measures will assess any changes to physical and mental health and reduce the impact of headaches via EQ-5DL - quality of life measure. 5 questions rated on levels with 5 being the highest level of disability and an additional questions on overall health rated on a scale of 100 with 100 being the best possible health and 0 being being the worst possible health.
Measured: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start8 Apr 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheldon Yao, D.O, Principal investigator, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546462
- Sponsor's protocol ID
- Headache OMT
- Other IDs
- BHS-1852
- Status last verified
- Mar 2025
- First submitted
- 13 Nov 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jara Silva CE, Joseph AM, Khatib M, Knafo J, Karas M, Krupa K, Rivera B, Macia A, Madhu B, McMillan M, Burtch J, Quinonez J, Albert T, Khanna D. Osteopathic Manipulative Treatment and the Management of Headaches: A Scoping Review. Cureus. 2022 Aug 9;14(8):e27830. doi: 10.7759/cureus.27830. eCollection 2022 Aug.
PubMed 36110479Chin J, Qiu W, Lomiguen CM, Volokitin M. Osteopathic Manipulative Treatment in Tension Headaches. Cureus. 2020 Dec 12;12(12):e12040. doi: 10.7759/cureus.12040.
PubMed 33457139
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Specific OMT Protocol Influence Patient-reported Pain and Associated Analgesia Use for Primary Headache Disorders?
- ClinicalTrials.gov ID
- NCT06546462
- Acronym / sponsor ID
- Headache OMT
- Conditions
- Headache Disorders, Headache, Analgesia, Opioid Use, Osteopathy
- Keywords
- Osteopathic manipulative medicine, Osteopathic manipulative treatment, Headache
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 8 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- 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.
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.
Detailed description
The purpose of this study is to evaluate the effectiveness of osteopathic manipulative treatment protocol (OMT) or light touch protocol in reducing headache frequency and the use of pain medication for headache pain. Previous research has suggested that OMT may alleviate headache symptoms. This randomized controlled trial aims to determine whether regular OMT sessions can decrease headache discomfort and reduce the use of pain medications, including over-the-counter medications, migraine-specific treatments, and opioids. The study consists of a ten-week period, including 2 weeks of observation, 6 weeks of intervention, and 2 weeks of washout. Participants will be randomly assigned to either receive OMT or a light touch protocol. Investigators will compare questionnaires assessing quality of life and functionality scales. Pain levels and medication use will be logged daily throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulation arm | Experimental | Other: Osteopathic Manipulative Treatment (OMT)* 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 |
| Sham Light touch arm | Sham comparator | Other: Sham Light touch arm* 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 75 years of age
- takes opioids or any other pain medication for headaches more than 10 times a month (including over the counter and prescription medications for headaches).
- 3 months or greater history of headaches or migraines
- Patient able to tolerate OMT based on osteopathic physician discretion and with consideration of absolute and relative contraindications to OMT
Key exclusion criteria (6 listed)
- current diagnosis of neoplasm
- history of headache secondary to trauma or concussion
- history of brain/cranial surgery, cerebral vascular events/disease (e.g., stroke, Brain arteriovenous malformation (AVM), vertebral artery disease)
- acute psychiatric diagnosis
- pregnancy
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)The active arm will receive osteopathic manipulative treatment which is a hands-on treatment modality use to treat a variety of health concerns. | Other | Osteopathic Manipulation arm |
| Sham Light touch armSham arm will receive a light touch sham treatment. | Other | Sham Light touch arm |
Primary outcome
Change in pain levels
Time frame: Assessment of weekly average pain from week 1 till week 10 end of the study period
The primary outcome measures will assess if consistent use of OMT for headache causes a reduction in headache pain for headache-associated discomfort. Pain will be rated on a Numeric Rating Scale (NRS) so individuals can rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).
Change in analgesia use
Time frame: Assessment of weekly amount of pain medications used from week 1 till week 10 end of the study period
The primary outcome measures will assess if consistent use of OMT for headache causes a reduction in headache analgesia use for headache-associated discomfort.
3 secondary outcomes
Change in quality of Life - Headache disability index
Time frame: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
Change in quality of Life - Headache Impact Test (HIT-6)
Time frame: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
Change in quality of Life - The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group (EQ-5DL)
Time frame: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 36110479Jara Silva CE, Joseph AM, Khatib M, Knafo J, Karas M, Krupa K, Rivera B, Macia A, Madhu B, McMillan M, Burtch J, Quinonez J, Albert T, Khanna D. Osteopathic Manipulative Treatment and the Management of Headaches: A Scoping Review. Cureus. 2022 Aug 9;14(8):e27830. doi: 10.7759/cureus.27830. eCollection 2022 Aug.
- Background: PubMed 33457139Chin J, Qiu W, Lomiguen CM, Volokitin M. Osteopathic Manipulative Treatment in Tension Headaches. Cureus. 2020 Dec 12;12(12):e12040. doi: 10.7759/cureus.12040.
- Individual participant dataSharing planned: No
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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.
Sheldon Yao, D.O principal investigator
New York Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment (OMT) in people with Headache Disorders and Headache, run by New York Institute of Technology 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Mar 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheldon Yao, D.O (516-686-3754, syao@nyit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain levels (time frame: Assessment of weekly average pain from week 1 till week 10 end of the study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546462, which also lists 2 linked publications.
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 17 Mar 2025.