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Treatment of Cervical Pain in Chronic Migraine

Primary Purpose

Chronic Migraine

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment Using Counterstrain
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring Chronic migraine, Osteopathic manipulative treatment, Cervicalgia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Other

    Arm Label

    Control

    Treatment (conterstrain)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Treatment of Cervical Pain in Chronic Migraine
    Frequency of migraine days after treatment with Osteopathic manipulative treatment using counterstrain

    Secondary Outcome Measures

    Full Information

    First Posted
    February 26, 2018
    Last Updated
    April 29, 2022
    Sponsor
    University Hospitals Cleveland Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03453203
    Brief Title
    Treatment of Cervical Pain in Chronic Migraine
    Official Title
    Treatment of Cervical Pain in Chronic Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI left
    Study Start Date
    April 29, 2018 (Anticipated)
    Primary Completion Date
    December 29, 2018 (Anticipated)
    Study Completion Date
    December 29, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospitals Cleveland Medical Center

    4. Oversight

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

    5. Study Description

    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Migraine
    Keywords
    Chronic migraine, Osteopathic manipulative treatment, Cervicalgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Blinded control trial
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Treatment (conterstrain)
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Osteopathic Manipulative Treatment Using Counterstrain
    Other Intervention Name(s)
    Strain/Counterstrain
    Intervention Description
    Described in arm/group descriptions
    Primary Outcome Measure Information:
    Title
    Treatment of Cervical Pain in Chronic Migraine
    Description
    Frequency of migraine days after treatment with Osteopathic manipulative treatment using counterstrain
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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).

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Cervical Pain in Chronic Migraine

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