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Unilateral HeadacheNCT03385889

Effects of Cervical Manual Therapy on Cervicogenic Headache

A study testing Cervical Spine Mobilization and Cervical Spine Manipulation in people with Unilateral Headache and Musculoskeletal Neck Pain, run by Shenandoah University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Cervical Spine Mobilization and Cervical Spine Manipulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
15 Feb 2018to 1 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Shenandoah University

    Winchester, Virginia, 22601

Other trials in United States

About this study

Official title: Effects of Cervical Spine Manual Therapy on Range of Motion, Joint Position Sense, and Balance in Participants With Cervicogenic Headache

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.

Read the 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.

Being tested
Cervical Spine Mobilization, Cervical Spine Manipulation
Keywords
Cervicogenic Headache, Manual Therapy, Joint Position Sense, Balance
Medical subject headings
Headache, Post-Traumatic Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical Spine MobilizationProcedure or surgery

    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 ManipulationProcedure or surgery

    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.

Study groups in NCT03385889
Study groupRoleWhat they receive
Cervical Spine Mobilization GroupExperimentalSubjects 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.
Receives: Procedure: Cervical Spine Mobilization
Cervical Spine Manipulation GroupExperimentalSubjects 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.
Receives: Procedure: Cervical Spine Manipulation
Control GroupNo interventionNo intervention. Subjects in this groups will wait for 5 minutes between pre- and post-testing of dependent variables.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Post-Intervention, 4-weeks

Secondary outcomes (2)

  1. Change in Joint Position Error

    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.

    Measured: Post-Intervention, 4-weeks

  2. Change in Balance as measured by NeuroCom Balance Master

    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.

    Measured: Post-Intervention, 4-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2017
  2. Study start15 Feb 2018
  3. Primary completion15 May 2018
  4. Study completion1 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pre-test, Post-test, control group design 3 groups - mobilization, manipulation, control
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03385889
Sponsor's protocol ID
ShenandoahU(2017-2018)
Status last verified
Apr 2019
First submitted
20 Dec 2017
Last updated
4 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23771276

  • 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.

    PubMed 26852024

  • 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.

    PubMed 24792139

  • 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.

    PubMed 19411769

  • 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.

    PubMed 25983238

Questions about this trial

What is this clinical trial studying?

A study testing Cervical Spine Mobilization and Cervical Spine Manipulation in people with Unilateral Headache and Musculoskeletal Neck Pain, run by Shenandoah University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cervical Flexion Rotation Test (CFRT) (time frame: Post-Intervention, 4-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03385889, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.

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