Can a Specific OMT Protocol Influence Patient Pain and Associated Analgesia Use for Primary Headache Disorders?

NCT ID: NCT06546462

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Headache Disorders; Headache; Analgesia; Opioid Use; Osteopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Osteopathic Manipulation arm

• 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 Type: EXPERIMENTAL

Osteopathic Manipulative Treatment (OMT)

Intervention Type: 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 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.

Group Type: SHAM_COMPARATOR

Sham Light touch arm

Intervention Type: OTHER

Sham arm will receive a light touch sham treatment.

Interventions

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.

Intervention Type: OTHER

Sham Light touch arm

Sham arm will receive a light touch sham treatment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheldon Yao, D.O

Role: PRINCIPAL_INVESTIGATOR

New York Institute of Technology

Locations

Riland Academic Health Care Center

Old Westbury, New York, United States

Countries

United States

Central Contacts

Sheldon Yao, D.O

Role: CONTACT

syao@nyit.edu

516-686-3754

References

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.

Reference Type: BACKGROUND

PMID: 36110479 (View on PubMed)

Chin 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.

Reference Type: BACKGROUND

PMID: 33457139 (View on PubMed)

Other Identifiers

BHS-1852

Identifier Type: OTHER

Identifier Source: secondary_id

Headache OMT

Identifier Type: -

Identifier Source: org_study_id