Manual Therapy and Exercise in Patients With Cervicogenic Headache

November 12, 2014 updated by: Alabama Physical Therapy & Acupuncture

Effect of Upper Cervical and Upper Thoracic Thrust Manipulation Versus Mobilization and Exercise in Patients With Cervicogenic Headache

Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper thoracic thrust manipulation will demonstrate significant and clinically important changes in outcomes when compared to the mobilization and exercise group.

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

Patients with cervicogenic headache will be randomized to receive 6-8 sessions over 2-4 weeks of either: (1) upper cervical and upper thoracic thrust manipulation, or (2) upper cervical and upper thoracic non-thrust mobilization and range of motion, strength and postural exercises.

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 (Anticipated)

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.
112

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
    • Alabama
      • Montgomery, Alabama, United States, 36117
        • Alabama Physical Therapy & Acupuncture

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
  • Headache frequency of at least one per week for a minimum of 3 months
  • Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50

Exclusion Criteria:

  • Bilateral headaches
  • Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
  • Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
  • History of whiplash injury within the last 6 weeks
  • Diagnosis of cervical spinal stenosis
  • Bilateral upper extremity symptoms
  • Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes)

  • Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

    • Muscle weakness involving a major muscle group of the upper extremity.
    • Diminished upper extremity deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
    • Diminished or absent sensation to pinprick in any upper extremity dermatome
  • Prior surgery to the neck or thoracic spine.
  • Involvement in litigation or worker's compensation regarding their neck pain and/or headaches.
  • Physical therapy or chiropractic treatment for neck pain or headache in the 3 months before baseline examination.
  • Any condition that might contraindicate spinal manipulative therapy

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: Double

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: Thrust manipulation
Other: Thrust Manipulation
Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.
Other Names:
  • High-velocity low-amplitude thrust manipulation of the spine
Active Comparator: Non-thrust mobilization and exercise
Other: Non-thrust Mobilization and Exercise
Upper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks.
Other Names:
  • Non-thrust mobilization to cervical and thoracic spines
  • Cervical range of motion, strength, and postural exercises

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
Headache Frequency
Time Frame: Baseline
The number of headache days in the past week (as registered in headache diary)
Baseline
Headache Frequency
Time Frame: 1-week
The number of headache days in the past week (as registered in headache diary)
1-week
Headache Frequency
Time Frame: 4-weeks
The number of headache days in the past week (as registered in headache diary)
4-weeks
Headache Frequency
Time Frame: 3-months
The number of headache days in the past week (as registered in headache diary)
3-months
Headache Intensity
Time Frame: Baseline
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Baseline
Headache Intensity
Time Frame: 1-week
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
1-week
Headache Intensity
Time Frame: 4-weeks
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
4-weeks
Headache Intensity
Time Frame: 3-months
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
3-months
Headache Duration
Time Frame: Baseline
Average number of headache hours in the last week (as registered in the headache diary)
Baseline
Headache Duration
Time Frame: 1-week
Average number of headache hours in the last week (as registered in the headache diary)
1-week
Headache Duration
Time Frame: 4-weeks
Average number of headache hours in the last week (as registered in the headache diary)
4-weeks
Headache Duration
Time Frame: 3-months
Average number of headache hours in the last week (as registered in the headache diary)
3-months
Neck Disability Index (NDI)
Time Frame: Baseline
Neck pain and disability
Baseline
Neck Disability Index (NDI)
Time Frame: 1-week
Neck pain and disability
1-week
Neck Disability Index (NDI)
Time Frame: 4-weeks
Neck pain and disability
4-weeks
Neck Disability Index (NDI)
Time Frame: 3-months
Neck pain and disability
3-months

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
Global Rating of Change (GROC)
Time Frame: 1-week
Perceived improvement.
1-week
Global Rating of Change (GROC)
Time Frame: 4-weeks
Perceived improvement.
4-weeks
Global Rating of Change (GROC)
Time Frame: 3-months
Perceived improvement.
3-months
Analgesic Use
Time Frame: Baseline
Analgesic (medication intake) use per day (as registered in the headache diary).
Baseline
Analgesic Use
Time Frame: 3-months
Analgesic (medication intake) use per day (as registered in the headache diary).
3-months

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.
Alabama Physical Therapy & Acupuncture

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Long Island 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 Chair: Marshall Hagins, PT, PhD, Long Island 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

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.
April 1, 2012

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.
August 1, 2014

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.
August 1, 2014

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).
April 16, 2012

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.
April 17, 2012

First Posted (Estimate)

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.
April 19, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
November 14, 2014

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.
November 12, 2014

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.
November 1, 2014

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.
  • 12/01-006

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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