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

NCT ID: NCT03588364

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-15
• Study Completion Date: 2019-06-30

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.

Detailed Description

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. The investigators selected this control condition to improve our statistical power in this small pilot study. As noted, all participants will continue to receive standard of care throughout the study as a washout is not feasible with osteopathic manipulation and removing standard of care could exacerbate the participant's symptoms. Participants in both arms will be followed for another 12 weeks after the 12 weeks of OMT, resulting in 24 weeks of study participation for the immediate treatment group and 30 weeks of study participation for the delayed treatment group, with participants in both arms answering a series of questionnaires to evaluate migraine frequency and impact, treatment efficacy, side effects, adherence t standard of care and depressive symptoms every 6 weeks throughout their study participation. Participant encounters will consist of screening, psychometric and functional scale administration at every 6 weeks for a total of 24-30 weeks, as well as 12 weeks of OMT treatments for participants in both study arms. Study participants will likely come from UCSD internal referrals.

Conditions

Migraine Disorders; Post-Traumatic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Osteopathic Manipulation

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

Group Type: EXPERIMENTAL

Osteopathic Manipulation

Intervention Type: 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.

Waitlist Control

Six-week waiting period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Osteopathic Manipulation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Hollis King

Health Sciences Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hollis H King, DO, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

La Jolla, California, United States

Countries

United States

Other Identifiers

OMT/mTBI

Identifier Type: -

Identifier Source: org_study_id