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Effects of Cervical Manual Therapy on Cervicogenic Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03385889
Recruitment Status : Completed
First Posted : December 29, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Aaron Hartstein, Shenandoah University

Brief Summary:
The effects of cervical spine manual therapy, including mobilization and manipulation, on cervical spine range of motion, joint position sense, and balance is unknown among individuals with cervicogenic headache. Previous studies have indicated improved frequency of headache, decreased perceived disability, and demonstrated improved neuromuscular function following upper cervical manipulation. Other authors report improved cervical spine range of motion, joint position sense, and balance following cervical spine manual therapy for individuals with cervicogenic dizziness. Through an experimental design, this study aims to determine the effects of cervical spine manual therapy on variables such as cervical spine range motion, joint position sense, and balance among individuals with headache of a cervical spine origin.

Condition or disease Intervention/treatment Phase
Unilateral Headache Musculoskeletal Neck Pain Procedure: Cervical Spine Mobilization Procedure: Cervical Spine Manipulation Not Applicable

Detailed Description:
A convenience sample will be utilized to obtain subjects who suffer from cervicogenic headaches, as defined by the International Headache Classification. Subjects will be given an online medical screening questionnaire to differentiate and screen additional types of headache symptoms (migraine, cluster, tension-type, for example) and identify possible contraindications for manual therapy treatment techniques and exclude individuals if necessary. Subjects will be randomized into one of three groups (upper cervical mobilization, upper cervical manipulation, or control) and be tested with the Cervical Flexion Rotation Test, Joint Position Error testing, and sensorimotor balance testing via NeuroCom Balance Master. Subjects with cervicogenic headaches will receive their assigned intervention and dependent variables will be reassessed immediately, as well as 4-weeks after initial intervention. Individuals in either intervention group (mobilization or manipulation) will also complete a specific home-exercise program, which has been reported to improve upper cervical range of motion, to the C1/2 segment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pre-test, Post-test, control group design 3 groups - mobilization, manipulation, control
Masking: Single (Outcomes Assessor)
Masking Description: Assessors of joint position sense, balance, and cervical spine range of motion via the Cervical Flexion Rotation Test will be blinded to group allocation
Primary Purpose: Treatment
Official Title: Effects of Cervical Spine Manual Therapy on Range of Motion, Joint Position Sense, and Balance in Participants With Cervicogenic Headache
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cervical Spine Mobilization Group
Subjects with cervicogenic headache who will be assigned to cervical spine mobilization group and receive intervention directed to C1/2 of ipsilateral side of unilateral dominant headache.
Procedure: Cervical Spine Mobilization
C1/2 graded mobilizations (Grade III/IV) provided to C1/2 segment on ipsilateral side of unilateral headache. Mobilizations will be completed for 3 sets of 30 seconds.

Experimental: Cervical Spine Manipulation Group
Subjects with cervicogenic headache who will be assigned to cervical spine manipulation group and receive intervention directed to C1/2 of ipsilateral side of unilateral dominant headache.
Procedure: Cervical Spine Manipulation
C1/2 manipulation (Grade V) provided to C1/2 segment on ipsilateral side of unilateral headache. The goal of the manipulation technique is to elicit an audible cavitation. If no cavitation is achieved upon the first attempt, a second and final attempt will be completed. No more than two attempts will be utilized per each subject in this allocated group.

No Intervention: Control Group
No intervention. Subjects in this groups will wait for 5 minutes between pre- and post-testing of dependent variables.



Primary Outcome Measures :
  1. Change in Cervical Flexion Rotation Test (CFRT) [ Time Frame: Post-Intervention, 4-weeks ]
    The Cervical Range of Motion (CROM) instrument will be placed on the subject. The subject will lie supine on the treatment table. The investigator will then passively flex the entire cervical spine and then rotate the head to both the left and right. The range of motion available in each direction, as measured by the CROM, will be recorded.


Secondary Outcome Measures :
  1. Change in Joint Position Error [ Time Frame: Post-Intervention, 4-weeks ]
    The subject will have a small laser pointer mounted onto a lightweight headband, which they will wear. The patient will be seated 90 cm from the wall. The starting point that is projected by the laser on the bullseye is marked. The patient will have their eyes closed and will perform an active neck movement. After this, the patient will return their head as accurately as possible to the starting position. This will include 6 trials, which will include cervical flexion, extension and rotation. The final laser position is measured against the starting position in centimeters. Errors will be measured following active return from cervical extension, flexion and rotation.

  2. Change in Balance as measured by NeuroCom Balance Master [ Time Frame: Post-Intervention, 4-weeks ]
    A pre-programmed option on the NeuroCom Balance Master will be utilized to assess the Modified Clinical test of Sensory Interaction on Balance (mCTSIB). Three different conditions will be utilized and each condition will last 30 secs. Three trials will be completed for each condition.First, the subject will be asked to maintain their balance while their eyes are closed. The amount of postural sway that they demonstrate will be recorded. Second, the subject will be asked to maintain their balance with their eyes open while the platform on the NeuroCom Balance Master force plate moves. The amount of postural sway demonstrated will be recorded. Third, the subject will be asked to rotate their head all the way to the left, then rotate their head all the way to the right. They will continue rotating between sides for the duration of the 30 second trial. The amount of postural sway that they demonstrate will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over the age of 18
  • Signs and symptoms consistent with cervicogenic headache (including unilateral headache, headache that improves or resolves as cervical disorder or lesion improves or resolves, headache that is made worse with cervical movement or sustained painful neck positions, reduced cervical range of motion
  • Headache frequency of at least once a week for 3 months

Exclusion Criteria:

  • Bilateral headaches
  • Non-musculoskeletal red flags
  • Two or more positive neurologic signs indicative of nerve root compression
  • Diagnosed with cervical spinal stenosis
  • Bilateral upper extremity symptoms
  • Symptoms indicative of central nervous system lesion
  • History of whiplash injury within the previous 6 weeks
  • Prior head or neck surgery
  • Has received treatment for head or neck pain from any practitioner within the previous month
  • Has received physical therapy or chiropractic treatment for head or neck pain within the previous 3 months
  • Having a known vestibular or balance dysfunction (BPPV, unilateral vestibular loss, etc.)
  • Other headaches that do not originate from the cervical spine, primarily migraine, vascular (cervical artery dysfunction), and tension-type headache.

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): NCT03385889


Locations
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United States, Virginia
Shenandoah University
Winchester, Virginia, United States, 22601
Sponsors and Collaborators
Shenandoah University
Investigators
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Study Director: Karen Abraham, PhD, PT Shenandoah University

Publications of Results:
Other Publications:
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Responsible Party: Aaron Hartstein, Assistant Professor of Physical Therapy, Shenandoah University
ClinicalTrials.gov Identifier: NCT03385889    
Other Study ID Numbers: ShenandoahU(2017-2018)
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aaron Hartstein, Shenandoah University:
Cervicogenic Headache
Manual Therapy
Joint Position Sense
Balance
Additional relevant MeSH terms:
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Post-Traumatic Headache
Headache
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases