Effects of Cervical Manual Therapy on Cervicogenic Headache

NCT ID: NCT03385889

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2019-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Unilateral Headache Musculoskeletal Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pre-test, Post-test, control group design 3 groups - mobilization, manipulation, control
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessors of joint position sense, balance, and cervical spine range of motion via the Cervical Flexion Rotation Test will be blinded to group allocation

Study Groups

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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.

Group Type EXPERIMENTAL

Cervical Spine Mobilization

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Cervical Spine Manipulation

Intervention Type PROCEDURE

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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenandoah University

OTHER

Sponsor Role lead

Responsible Party

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Aaron Hartstein

Assistant Professor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Abraham, PhD, PT

Role: STUDY_DIRECTOR

Shenandoah University

Locations

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Shenandoah University

Winchester, Virginia, United States

Site Status

Countries

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United States

References

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Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.

Reference Type BACKGROUND
PMID: 23771276 (View on PubMed)

Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.

Reference Type RESULT
PMID: 26852024 (View on PubMed)

Reid SA, Callister R, Katekar MG, Rivett DA. Effects of cervical spine manual therapy on range of motion, head repositioning, and balance in participants with cervicogenic dizziness: a randomized controlled trial. Arch Phys Med Rehabil. 2014 Sep;95(9):1603-12. doi: 10.1016/j.apmr.2014.04.009. Epub 2014 May 2.

Reference Type RESULT
PMID: 24792139 (View on PubMed)

Kristjansson E, Treleaven J. Sensorimotor function and dizziness in neck pain: implications for assessment and management. J Orthop Sports Phys Ther. 2009 May;39(5):364-77. doi: 10.2519/jospt.2009.2834.

Reference Type RESULT
PMID: 19411769 (View on PubMed)

de Vries J, Ischebeck BK, Voogt LP, van der Geest JN, Janssen M, Frens MA, Kleinrensink GJ. Joint position sense error in people with neck pain: A systematic review. Man Ther. 2015 Dec;20(6):736-44. doi: 10.1016/j.math.2015.04.015. Epub 2015 May 2.

Reference Type RESULT
PMID: 25983238 (View on PubMed)

Other Identifiers

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ShenandoahU(2017-2018)

Identifier Type: -

Identifier Source: org_study_id

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