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NCT Number: NCT06546462

Can a Specific OMT Protocol Influence Patient 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riland Academic Health Care Center

Old Westbury, New York, 11545, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 arm

Other

Sham arm will receive a light touch sham treatment.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sheldon Yao, D.O

CONTACT

[email protected]

516-686-3754

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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