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Search / Trial NCT06546462

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

Launched by NEW YORK INSTITUTE OF TECHNOLOGY · Aug 6, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Osteopathic Manipulative Medicine Osteopathic Manipulative Treatment Headache

ClinConnect Summary

This clinical trial is exploring whether a type of treatment called osteopathic manipulation can help reduce the frequency of headaches and the need for pain medications. The researchers want to find out if regular sessions of this hands-on therapy can lessen headache discomfort and decrease the use of over-the-counter and prescription pain medications, including opioids. Participants will be randomly assigned to receive either the osteopathic manipulation or a light touch treatment that does not involve any real therapy. Throughout the study, participants will fill out questionnaires about their pain levels and medication use to see if there are any changes.

To participate in this trial, individuals must be between 18 and 75 years old and must currently take pain medications for headaches more than ten times a month. They should have a history of headaches or migraines for at least three months. However, some people may not be eligible, such as those with certain medical conditions, recent surgeries, or a history of substance use disorders. If you join the study, you can expect to receive either the treatment or a placebo, and your experiences will help researchers understand the effectiveness of this approach for headache relief.

Gender

ALL

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

About New York Institute Of Technology

The New York Institute of Technology (NYIT) is a distinguished institution recognized for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, NYIT leverages its expertise in health sciences, engineering, and technology to conduct rigorous studies that aim to improve patient outcomes and address pressing medical challenges. The institute is dedicated to fostering a conducive environment for clinical research, ensuring compliance with ethical standards, and promoting the translation of findings into practical applications in the healthcare sector.

Locations

Old Westbury, New York, United States

Patients applied

0 patients applied

Trial Officials

Sheldon Yao, D.O

Principal Investigator

New York Institute of Technology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported