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

NCT06546462 | Not Yet Recruiting DMC

• 2 other identifiers: Headache OMTBHS-1852
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache Disorders; Headache; Analgesia; Opioid Use; Osteopathy

Keywords

Osteopathic manipulative medicine; Osteopathic manipulative treatment; Headache

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in quality of Life - Headache disability index

  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)

  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)

  To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)

Study Arms (2)

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

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.

Other: Sham Light touch arm

Interventions

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.

Osteopathic Manipulation arm

Sham Light touch arm OTHER

Sham arm will receive a light touch sham treatment.

Sham Light touch arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

Riland Academic Health Care Center

Old Westbury, New York, 11545, United States

Location

Related Publications (2)

• 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.

  PMID: 36110479 BACKGROUND

• 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.

  PMID: 33457139 BACKGROUND

MeSH Terms

Conditions

Headache Disorders; Headache; Agnosia

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sheldon Yao, D.O

  New York Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheldon Yao, D.O

CONTACT

516-686-3754; syao@nyit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: August 9, 2024
• Study Start: April 8, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)