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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia; Headache; Headache Disorders; Opioid Use; Osteopathy
• Intervention / Treatment: Other: Osteopathic Manipulative Treatment (OMT); Other: Sham Light touch arm

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheldon Yao, D.O; Phone Number: 516-686-3754; Email: syao@nyit.edu

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11545
      • Riland Academic Health Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.Thoracic inlet release: 45 seconds maximumSuboccipital release: 1 minute maximumOccipito-mastoid suture release: 1 minute maximumVenous sinus drainage: 1 minute maximumBalanced membranous tension: 1 minute maximumCompression of the 4th Ventricle (CV4): 1 minute maximumCervical soft tissue: 1 minute maximumTrapezius inhibition: 45 seconds maximumBilateral rib raising: 2 minutes max (1 min per side)Sacroiliac gapping: 1 minute maximumSacral rock: 1 minute maximumSeated bilateral thoracic and lumbar paraspinal articulation: 2 minutes maximum	Other: 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.
Sham Comparator: 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.	Other: Sham Light touch arm; Sham arm will receive a light touch sham treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Assessment of weekly amount of pain medications used from week 1 till week 10 end of the study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)

Collaborators and Investigators

• Sponsor: New York Institute of Technology
• Investigators: Principal Investigator: Sheldon Yao, D.O, New York Institute of Technology

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 8, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Headache; Osteopathic manipulative treatment; Osteopathic manipulative medicine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache; Headache Disorders, Primary
• Other Study ID Numbers: Headache OMT; BHS-1852 (Other Identifier: New York Institute of Technology BHS-IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No