Effects of Cervical Manual Therapy on Cervicogenic Headache

April 2, 2019 updated by: Aaron Hartstein, Shenandoah University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Shenandoah University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Post-Intervention, 4-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Post-Intervention, 4-weeks
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.
Post-Intervention, 4-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenandoah University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Karen Abraham, PhD, PT, Shenandoah University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ShenandoahU(2017-2018)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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