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Osteopathic Manipulative Treatment and Migraine Headaches

Primary Purpose

Chronic Migraine, Migraine Disorders, Headache Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Therapy (OMT)
Standard of care
Sponsored by
St. Luke's Hospital, Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring OMT, Osteopathic Manipulative Therapy, Migraine, Headache

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous Surgery to neck or cranium, history of previous stroke
  2. More than two daily prophylactic pharmacologic agents used for the indication of Migraine headache
  3. Active cancer
  4. Receiving BOTOX® for migraines or treatment within the last 4 months
  5. 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
  6. If patient is poor candidate for OMT in intervention group such as the patient is unable to follow commands.
  7. Seizure disorder or recent head trauma
  8. Pregnant or become pregnant during the treatment period

Sites / Locations

  • St. Luke's University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Interventional Group receiving Osteopathic Manipulative Therapy (OMT)

Control Group with Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Headache Days
Reduction in the number of headache days over 12 weeks
Pain scale
Reduction in the pain scale (1-10) for migraine headaches

Full Information

First Posted
July 15, 2021
Last Updated
July 27, 2021
Sponsor
St. Luke's Hospital, Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04976985
Brief Title
Osteopathic Manipulative Treatment and Migraine Headaches
Official Title
The Efficacy of Osteopathic Manipulative Treatment on Decreasing the Severity of Migraine Headaches
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's Hospital, Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
According to the American Headache Society, Migraine headaches affect one billion people worldwide. In the United States, one in five women and one in sixteen men suffer from migraine headaches. Migraine is the sixth most disabling illness in the world. More than four million people have chronic daily migraines with at least 15 migraines per month. More than 90% of sufferers are unable to work or function normally during their migraine attacks. Unlike many other chronic diseases, migraine affects otherwise healthy, young and middle aged people. Headache accounts for the fourth or fifth most common reason for emergency department visits and the economic burden of migraine reaches $78 billion dollars per year. Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, non-invasive form of manual medicine. Headache has been shown to be associated with impairment of autonomic nervous system including autonomic nuclei responsible for pain perception. It has also been shown through research that persons with a migraine episode are known to release high levels of the pro-inflammatory agents, prostaglandins, dopamine and serotonin. The effect of OMT on headache can be two fold: First, by increasing parasympathetic tone, and second, by inhibiting pro-inflammatory substances. Therefore, OMT could theoretically counter balance both the release of pro-inflammatory markers as well as the autonomic nervous system leading to improved clinical outcomes. These outcomes include: decreasing patients' severity and frequency of their migraine headache, which, ultimately could improve subjects' productivity to society and decrease the economic burden of migraine sufferers. Historically, OMT was believed to worsen migraine headaches, this study is being conducted to learn about how Osteopathic Manipulative Therapy can help migraine patients. Subjects receiving OMT could benefit from improved quality of life by reducing subject's severity and frequency of their migraine headache, which could improve their productivity to society and decrease the economic burden of migraine headaches. This could provide information to make Osteopathic Manipulative Therapy an acknowledged alternative therapy to improve quality of life for 3 million chronic migraine sufferers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Migraine Disorders, Headache Disorders, Headache, Migraine
Keywords
OMT, Osteopathic Manipulative Therapy, Migraine, Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Group receiving Osteopathic Manipulative Therapy (OMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group with Standard of Care
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Therapy (OMT)
Other Intervention Name(s)
OMT
Intervention Description
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: Occipital- Alanto release Muscle energy and soft tissue to mid trapezius muscle Muscle energy to cervical spine in all three planes of flexion/extension, rotation and side bending Screening for tender points of C2-C6 at transverse and spinous processes and treatment with counterstain if tender point identified Soft tissue to cervical paraspinal muscles Myo-fascial release of frontal forehead CV4 cranial technique
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in the Migraine Disability Test (MIDAS) score in the OMT interventional group compared to control group.
Description
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)
Time Frame
12 weeks
Title
Reduction in the Headache Impact Test (HIT-6) score in OMT intervention group compared to control group.
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Headache Days
Description
Reduction in the number of headache days over 12 weeks
Time Frame
12 weeks
Title
Pain scale
Description
Reduction in the pain scale (1-10) for migraine headaches
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abby Rhoads, DO
Organizational Affiliation
St. Luke's Hospital and Health Network, Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's University Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29527677
Citation
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.
Results Reference
background
PubMed Identifier
20097115
Citation
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.
Results Reference
background
PubMed Identifier
28352200
Citation
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.
Results Reference
background
PubMed Identifier
21385086
Citation
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.
Results Reference
background
PubMed Identifier
15784928
Citation
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.
Results Reference
background
PubMed Identifier
26214822
Citation
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.
Results Reference
background
Citation
Francesco Cerritelli, et al. Is osteopathic manipulative treatment effective in migraine?. International Journal of Osteopathic Medicine. March 2013Volume 16, Issue 1, Pages e1-e2.
Results Reference
background
Links:
URL
https://americanheadachesociety.org/wp-content/uploads/2018/05/GENERALMIGRIANE_FINAL_WEB.pdf
Description
American Headache Society - General Migraine information
URL
https://osteopathic.org/what-is-osteopathic-medicine/osteopathic-manipulative-treatment/
Description
AOA - What is Osteopathic Medicine

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Osteopathic Manipulative Treatment and Migraine Headaches

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