NCT03385889

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

December 20, 2017

Last Update Submit

April 2, 2019

Conditions

Keywords

Cervicogenic HeadacheManual TherapyJoint Position SenseBalance

Outcome Measures

Primary Outcomes (1)

  • Change in Cervical Flexion Rotation Test (CFRT)

    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.

    Post-Intervention, 4-weeks

Secondary Outcomes (2)

  • Change in Joint Position Error

    Post-Intervention, 4-weeks

  • Change in Balance as measured by NeuroCom Balance Master

    Post-Intervention, 4-weeks

Study Arms (3)

Cervical Spine Mobilization Group

EXPERIMENTAL

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

Cervical Spine Manipulation Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

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 Mobilization Group

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.

Cervical Spine Manipulation Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenandoah University

Winchester, Virginia, 22601, United States

Location

Related Publications (5)

  • 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.

    PMID: 23771276BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

HeadachePost-Traumatic Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Karen Abraham, PhD, PT

    Shenandoah University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors of joint position sense, balance, and cervical spine range of motion via the Cervical Flexion Rotation Test will be blinded to group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pre-test, Post-test, control group design 3 groups - mobilization, manipulation, control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 29, 2017

Study Start

February 15, 2018

Primary Completion

May 15, 2018

Study Completion

January 1, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations