The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine

NCT03588364 | Completed

• 1 other identifier: OMT/mTBI
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the use of osteopathic manipulation (manual medicine) for migraine headache following traumatic head injury. Headache is an important and very common somatic complaint among people with traumatic brain injury and an important cause of disability in the United States. Over 15-percent of soldiers deployed to Iraq sustained concussion. A majority of these patients suffer from headaches. Many of these are classified as migraine headache that do not respond to medications. Osteopathic manipulation is practiced by physicians in the United States and has been shown to be beneficial in some migraine patients. However, its use in the management of persistent post-traumatic headaches has not been explored. The investigators will use a randomized cross-over design to evaluate post-traumatic migraine patients' response to osteopathic manipulation.

Conditions

Migraine Disorders; Post-Traumatic Headache

Keywords

osteopathic manipulation

Outcome Measures

Primary Outcomes (1)

• Headache Frequency Log

  Participants will complete a form indicating the frequency, location, duration, characteristics, and associated features of their headache.

  6 weeks

Secondary Outcomes (3)

• Migraine Disability Assessment Score (MIDAS)

  6 weeks

• Center for Epidemiological Studies-Depression (CES-D)

  6 weeks

• 36-Item Short Form Survey Instrument (MOS-SF-36)

  6 weeks

Study Arms (2)

Osteopathic Manipulation

EXPERIMENTAL

Twelve weekly sessions using the techniques of osteopathy in the cranial field.

Other: Osteopathic Manipulation

Waitlist Control

NO INTERVENTION

Six-week waiting period.

Interventions

Osteopathic Manipulation OTHER

Osteopathic manipulation involves a number of different manual techniques. These include muscle inhibition; myofascial release; muscle energy stretch; counterstrain; facilitated positional release ; osteopathy in the cranial field ; balanced ligamentous tension/ligamentous articular strain; one or all of these techniques may be used. Participants will be positioned on an exam table supine, seated, lateral decubitus, prone, or in their position of greatest comfort for the procedure.

Osteopathic Manipulation

Eligibility Criteria

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

You may qualify if:

• History of TBI, concussion, post-concussive syndrome
• Headache frequency \>/equal 4 per month
• Post-traumatic headache, migraine type
• MIDAS Grade I-IV
• Headaches continue to occur 3 months to 1 year after the injury
• No history of uncontrolled migraine prior to head injury

You may not qualify if:

• Headache medication change (Tricyclic antidepressant, antiepileptic medication, propranolol, verapamil, duloxetine, butterbur, Botox) within 30 days
• Non-pharmacologic headache management change (reduction in caffeine intake, reduction in alcohol intake, sleep hygiene, exercise) within 30 days
• Less than 3 months from injury
• History of uncontrolled migraine prior to TBI
• Currently taking oral anti-coagulants

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Post-Traumatic Headache

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Secondary

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hollis H King, DO, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the study coordinator and the participants are privy to the assigned treatment arm (immediate vs. delayed) until the study is complete and the database is locked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Clinical Professor

Model Details: This is a 30-week prospective, randomized delayed treatment control group design in which 20 participants from the community will be randomized 1:1 into (a) an immediate treatment group that will receive 12 weeks of osteopathic manipulation (OMT) treatment plus standard of care right away or (b) delayed treatment group that will receive 12 weeks of OMT plus standard of care after a 6-week waiting period. The delayed treatment group initially serves as a control condition but then receives the experimental treatment.

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 17, 2018
• Study Start: September 15, 2016
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)