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Treatment of Cervical Pain in Chronic Migraine

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ClinicalTrials.gov Identifier: NCT03453203
Recruitment Status : Not yet recruiting
First Posted : March 5, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew Banks, University Hospitals Cleveland Medical Center

Brief Summary:
Chronic migraine (CM) is defined as a headache that occurs more than 15 days per month, which has the features of migraine headache on at least 8 days per month.1 The cause of CM is not well understood. Many patients with CM appear to have associated musculoskeletal neck pain. The purpose of this study is to treat cervicalgia in patients with migraine and to look for improvement in migraine frequency and intensity. Osteopathic manipulative treatment (OMT) can diagnose and treat common musculoskeletal dysfunction. This may break facilitation within the nervous system and reduce musculoskeletal pain which subsequently will reduce headache frequency. This will be a randomized controlled trail comparing patients with CM treated with OMT vs no treatment. The investigators will look at the frequency of migraine days before and after the treatment period to determine migraine frequency and improvement.

Condition or disease Intervention/treatment Phase
Chronic Migraine Other: Osteopathic Manipulative Treatment Using Counterstrain Not Applicable

Detailed Description:

Data will be analyzed by reviewing the amount of headache days during the treatment period

Patients will be distributed randomly into either the treatment arm or control arm. Subjects will be randomized as they are recruited for the study (i.e. subject 1 treatment, subject 2 control, subject 3 treatment, etc.) The participants will be distributed by a research assistant who will allocate the patients randomly to one of the two arms.

Both arms will be diagnosed using tenderpoints (Tenderpoints are small tense edematous areas of tenderness about the size of a fingertip. They are typically located near bony attachments of tendons, ligaments, or in the belly of some muscles).Tenderpoints will be documented and stored in a secure flash drive.

Treatment arm will be treated with an Osteopathic manipulative treatment called counterstrain technique. Osteopathic manipulative treatment is a hands on palpation of the tissues to diagnose and treat neuromusculoskeletal dysfunction. Counterstrain is a passive manipulative technique which the tissue being treated is positioned at a point of balance, or ease, AWAY from the restrictive barrier (The most thought of form of manipulative technique is high velocity low amplitude which is typically performed by chiropractors in spinal manipulation which goes TOWARD the restrictive barrier and actually pass through the restrictive barrier). Once a tenderpoint is found in the muscles the area of treatment is placed in a (three dimensional) position that will eliminate the sensation (tenderness).The treatment position is held for 90 seconds or until a release is felt (release is usually a decrease in the tone or muscle tension).

In the control arm the tenderpoint will Be palpated for 90 seconds with no counterstrain treatment applied. (Risk are possible soreness at palpation site though not likely, there is no benefit) Both treatment and control groups will remain on their current migraine medication regiment.

They will follow-up with Dr. Deborah Reed, MD, FAHS who is a board certified neurologist and headache specialist. This investigator will be blinded to weather the patient received counterstrain manipulation or no treatment. The investigator will document the number of headache days between follow-up periods.

After the first treatment follow-up will occur as follows: Week 1, Week 2, Week 4, Week 6, Week 10. This is picked somewhat arbitrarily as typical treatment follow-ups will vary from patient to patient depending on the severity of the musculoskeletal dysfunction (somatic dysfunction).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded control trial
Masking: Single (Care Provider)
Masking Description: The follow-up physician will be blinded to treatment vs control arm. Patient will be selected randomly depending on the time of recruitment.
Primary Purpose: Treatment
Official Title: Treatment of Cervical Pain in Chronic Migraine
Estimated Study Start Date : April 29, 2018
Estimated Primary Completion Date : December 29, 2018
Estimated Study Completion Date : December 29, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Control

Both arms with be diagnosed using tenderpoints In the control arm the tenderpoint will Be palpated for 90 secs with no counterstrain treatment applied.

Both treatment and control groups will remain on their current migraine medication regiment.

Other: Osteopathic Manipulative Treatment Using Counterstrain
Described in arm/group descriptions
Other Name: Strain/Counterstrain
Treatment (conterstrain)
Both arms with be diagnosed using tenderpoints. Treatment arm will be treated with counterstrain technique. Counterstrain is a passive manipulative technique which the tissue being treated is positioned at a point of balance, or ease, AWAY from the restrictive barrier (The most thought of form of manipulative technique is high velocity low amplitude which is typically performed by chiropractors in spinal manipulation which goes TOWARD the restrictive barrier and actually pass through the restrictive barrier). Once a tenderpoint is found in the muscles the area of treatment is placed in a (three dimensional) position that will eliminate the sensation (tenderness).The treatment position is held for 90 seconds or until a release is felt (a decrease in muscle tension). Both treatment and control groups will remain on their current migraine medication regiment.
Other: Osteopathic Manipulative Treatment Using Counterstrain
Described in arm/group descriptions
Other Name: Strain/Counterstrain



Primary Outcome Measures :
  1. Treatment of Cervical Pain in Chronic Migraine [ Time Frame: 3 months ]
    Frequency of migraine days after treatment with Osteopathic manipulative treatment using counterstrain



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-80 years of age who fit the ICHD-3 criteria for Chronic Migraine. These patients must be currently on an abortive agent (such as a triptans, NSAIDs) and require at least 8 doses a month.

Exclusion Criteria:

  • Patients will be excluded if there are any signs of secondary headaches. If they have received BOTOX therapy in the past 4 months or are currently receiving BOTOX therapy. If the patients have contraindications to counterstrain OMT (clinical signs of Fractures, ligament instability, severe vertebral artery disease) or are a poor candidate for OMT (unable to follow commands, unable to fully relax).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453203


Contacts
Contact: Matthew K Banks, DO 8649156701 matthew.banks@uhhospitals.org
Contact: Deborah Reed, MD 2168443192 Deborah.reed@uhhospitals.org

Sponsors and Collaborators
University Hospitals Cleveland Medical Center

Responsible Party: Matthew Banks, Doctor of Osteopathy, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03453203     History of Changes
Other Study ID Numbers: UHClevelandMC1
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthew Banks, University Hospitals Cleveland Medical Center:
Chronic migraine
Osteopathic manipulative treatment
Cervicalgia

Additional relevant MeSH terms:
Migraine Disorders
Neck Pain
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms