Osteopathic Manipulative Treatment and Migraine Headaches

NCT04976985 | Unknown

• 1 other identifier: 2018-106
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators hypothesize, that Osteopathic Manipulative Therapy (OMT) will reduce migraine disability and severity scores when compared to standard of care including prophylactic pharmacological agents with treatment over 12 week time frame. The investigators aim to decrease severity and disability of migraine by utilizing Osteopathic Manipulative Therapy. This would ultimately reduce the utilization of office or emergency department visits, decrease the large economic burden the United States faces for migraine patients as well as improve quality of life for the 3 million chronic migraine patients.

Conditions

Chronic Migraine; Migraine Disorders; Headache Disorders; Headache, Migraine

Keywords

OMT; Osteopathic Manipulative Therapy; Migraine; Headache

Outcome Measures

Primary Outcomes (2)

• Reduction in the Migraine Disability Test (MIDAS) score in the OMT interventional group compared to control group.

  Reduction in the Migraine Disability Test (MIDAS) score and level of disability per the MIDAS score scoring system: MIDAS Grade I (Little to no disability): 0-5 MIDAS Grade II(Mild Disability): 6-10 MIDAS Grade III (Moderate Disability): 11-20 MIDAS Grade IV (Severe Disability): 21+ minimum score: 0 maximum score: 21+ (no maximum)

  12 weeks

• Reduction in the Headache Impact Test (HIT-6) score in OMT intervention group compared to control group.

  Reduction in the Headache Impact Test (HIT-6) score per the scoring system: Little or no impact: 49 or Less Some impact: 50-55 Substantial Impact: 56-59 Severe Impact: 60-78 minimum score: 36 Maximum score: 78

  12 weeks

Secondary Outcomes (2)

• Headache Days

  12 weeks

• Pain scale

  12 weeks

Study Arms (2)

Interventional Group receiving Osteopathic Manipulative Therapy (OMT)

EXPERIMENTAL

70 patients with chronic migraine who consent to OMT will receive four standardized osteopathic manipulative treatment protocol over the course of twelve weeks at week 0,2,6,10. MIDAS and HIT-6 Questionnaires will be obtained at time of consent prior to first treatment and again at the conclusion of treatment period of twelve weeks.

Procedure: Osteopathic Manipulative Therapy (OMT)

Control Group with Standard of Care

OTHER

70 patients with the diagnosis of migraine headache who are receiving the standard of care medications will complete a MIDAS and HIT-6 questionnaire at week 0 and week 12. A new prophylactic medication may be started at time of initial questionnaires and the patient can be on up to two prophylactic medications, with no changes during the 12 week period.

Other: Standard of care

Interventions

Osteopathic Manipulative Therapy (OMT) PROCEDURE

Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic physicians receive special training in the musculoskeletal system to detect somatic dysfunction. Osteopathic physicians then move a patient's muscles and joints using techniques that include stretching, gentle pressure and resistance to improve muscle tonicity, treat structural abnormalities, relieve joint restriction, and decrease activation of the pain proprioception pathway. OMT Standardized Protocol A: 1. Occipital- Alanto release 2. Muscle energy and soft tissue to mid trapezius muscle 3. Muscle energy to cervical spine in all three planes of flexion/extension, rotation and side bending 4. Screening for tender points of C2-C6 at transverse and spinous processes and treatment with counterstain if tender point identified 5. Soft tissue to cervical paraspinal muscles 6. Myo-fascial release of frontal forehead 7. CV4 cranial technique

Also known as: OMT

Interventional Group receiving Osteopathic Manipulative Therapy (OMT)

Standard of care OTHER

Receiving standard of care for migraine headaches with pharmacological medications, with no more than two prophylactic medications during the study period. Participants may also take abortive migraine medications.

Control Group with Standard of Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-50
• Gender: Male and Female
• ICD 10 code of migraine with or without aura (G43.0, G43.1, G43.70, G43.71)
• No change in prophylactic medication for both control and intervention group
• No physical therapy for headaches, neck pain or for trapezius muscle during 12 weeks for both control and intervention group

You may not qualify if:

• Previous Surgery to neck or cranium, history of previous stroke
• More than two daily prophylactic pharmacologic agents used for the indication of Migraine headache
• Active cancer
• Receiving BOTOX® for migraines or treatment within the last 4 months
• If patient has contraindications for OMT for the intervention group such as clinical signs of fractures in cervical spine, ligament instability, or severe vertebral artery stenosis
• If patient is poor candidate for OMT in intervention group such as the patient is unable to follow commands.
• Seizure disorder or recent head trauma
• Pregnant or become pregnant during the treatment period

Sponsors & Collaborators

• St. Luke's Hospital, Pennsylvania: lead

Study Sites (1)

St. Luke's University Health Network

Bethlehem, Pennsylvania, 17901, United States

Location

Related Publications (7)

• Burch R, Rizzoli P, Loder E. The Prevalence and Impact of Migraine and Severe Headache in the United States: Figures and Trends From Government Health Studies. Headache. 2018 Apr;58(4):496-505. doi: 10.1111/head.13281. Epub 2018 Mar 12.

  PMID: 29527677 BACKGROUND

• Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: a systematic review. Man Ther. 2010 Aug;15(4):355-63. doi: 10.1016/j.math.2009.12.006. Epub 2010 Jan 22.

  PMID: 20097115 BACKGROUND

• Cerritelli F, Lacorte E, Ruffini N, Vanacore N. Osteopathy for primary headache patients: a systematic review. J Pain Res. 2017 Mar 14;10:601-611. doi: 10.2147/JPR.S130501. eCollection 2017.

  PMID: 28352200 BACKGROUND

• Voigt K, Liebnitzky J, Burmeister U, Sihvonen-Riemenschneider H, Beck M, Voigt R, Bergmann A. Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. J Altern Complement Med. 2011 Mar;17(3):225-30. doi: 10.1089/acm.2009.0673. Epub 2011 Mar 8.

  PMID: 21385086 BACKGROUND

• McReynolds TM, Sheridan BJ. Intramuscular ketorolac versus osteopathic manipulative treatment in the management of acute neck pain in the emergency department: a randomized clinical trial. J Am Osteopath Assoc. 2005 Feb;105(2):57-68.

  PMID: 15784928 BACKGROUND

• Zein-Hammoud M, Standley PR. Modeled Osteopathic Manipulative Treatments: A Review of Their in Vitro Effects on Fibroblast Tissue Preparations. J Am Osteopath Assoc. 2015 Aug;115(8):490-502. doi: 10.7556/jaoa.2015.103.

  PMID: 26214822 BACKGROUND

• Francesco Cerritelli, et al. Is osteopathic manipulative treatment effective in migraine?. International Journal of Osteopathic Medicine. March 2013Volume 16, Issue 1, Pages e1-e2.

  BACKGROUND

Related Links

• AOA - What is Osteopathic Medicine

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders; Headache

Interventions

Manipulation, Osteopathic; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Abby Rhoads, DO

  St. Luke's Hospital and Health Network, Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional group: 70 patients with chronic migraine who consent to OMT will receive four standardized osteopathic manipulative treatments over the course of twelve weeks. MIDAS and HIT-6 Questionnaires will be obtained at time of consent prior to first treatment and again at the conclusion of treatment period of twelve weeks. Control Group: 70 patients with the diagnosis of migraine headache will complete a MIDAS and HIT-6 questionnaire at week 0 and week 12 on standard of care for migraine treatment. A new prophylactic medication may be started at time of initial questionnaires and the patient can be on up to two prophylactic medications, with no changes during the 12 week period.

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: October 2, 2018
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)