Cervicogenic Headache Dose-Response (CGH D-R)

November 17, 2018 updated by: Mitchell Haas, University of Western States

Dose-Response of Manipulation for Cervicogenic Headache

This study will determine the number of visits to a chiropractor for spinal manipulation and light massage necessary for the optimal relief of cervicogenic headache (headache with associated neck pain). Effectiveness of care will also be determined.

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.

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.
256

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.
  • Phase 2
  • Phase 1

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
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Northwestern Health Sciences University
    • Oregon
      • Portland, Oregon, United States, 97230
        • University of Western States

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic cervicogenic headache
  • threshold pain level
  • threshold headache frequency
  • independently ambulatory
  • English literate
  • candidate for spinal manipulation

Exclusion Criteria:

  • contraindication to thrust spinal manipulation or massage
  • most other headache types
  • Recent manual/exercise therapy from licensed provider for head/neck
  • threshold pain medication use
  • pregnancy
  • involvement with another pain study
  • suspicion of unmanaged depression
  • most cancers
  • hypertension (at least stage II)
  • complicating neurological/spinal conditions
  • pre-randomization noncompliance or cannot/will not comply with protocols
  • health-related litigation, claims, or disability compensation

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: None (Open Label)

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: High dose spinal manipulation
18 visits for spinal manipulation
Other: Spinal Manipulation
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
Experimental: Moderate dose spinal manipulation
12 visits for spinal manipulation and 6 visits for light massage
Other: Spinal Manipulation
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
Other: Light Massage
5 minutes of light pressure massage to the neck and upper back
Experimental: Low dose spinal manipulation
6 visits for spinal manipulation and 12 visits for light massage
Other: Spinal Manipulation
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
Other: Light Massage
5 minutes of light pressure massage to the neck and upper back
Other: High dose massage
18 visits for light massage
Other: Light Massage
5 minutes of light pressure massage to the neck and upper back

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 days change from baseline for cervicogenic headache
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Days with cervicogenic headache in the last four weeks from a daily headache diary. Change score = follow-up score - baseline score)
0, 6, 12, 24, 39, 52 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
Average pain change from baseline for cervicogenic headache
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Average cervicogenic headache pain in the last four weeks evaluated by averaging daily headache diary pain scores. Pain is rated on a 0 to 11 numeric rating scale.
0, 6, 12, 24, 39, 52 weeks
Headache-related disability change from baseline for cervicogenic headaches
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Headache Impact Test (HIT-6)
0, 6, 12, 24, 39, 52 weeks
Headache-related disability days change from baseline
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Number of days in the last four weeks from recall unable to carry out daily work for at least one half day because of cervicogenic headache.
0, 6, 12, 24, 39, 52 weeks
EuroQol-5D change from baseline
Time Frame: 0, 12, 24, 39, 52 weeks
Health-related quality of life
0, 12, 24, 39, 52 weeks
Average pain change from baseline for neck
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Average neck pain in the last four weeks from recall. Pain is rated on a 0 to 11 numeric rating scale.
0, 6, 12, 24, 39, 52 weeks
Neck pain days change from baseline
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Number of days with neck pain in last 4 weeks from recall.
0, 6, 12, 24, 39, 52 weeks
medication use change from baseline
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Number days of use of prescription and nonprescription medications for headaches with neck pain
0, 6, 12, 24, 39, 52 weeks
Outside Care change from baseline
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Visits to providers outside the study for care of cervicogenic headache. Includes hospital and emergency room visits
0, 6, 12, 24, 39, 52 weeks
Patient Satisfaction
Time Frame: week 12
Likert scale for success of care
week 12
Objective biomechanical measures change from baseline
Time Frame: 0, 6 weeks
Measures of cervical joint function and kinematics including global range of motion, spinal segmental joint restriction, pain pressure thresholds
0, 6 weeks
Quality-adjusted life years change from baseline
Time Frame: 0, 12, 24, 39, 52 weeks
utility for cost-effectiveness analysis
0, 12, 24, 39, 52 weeks
Direct & Indirect costs change from baseline
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Health services; lost work days and productivity
0, 6, 12, 24, 39, 52 weeks
Perceived headache average pain change from baseline for cervicogenic headache
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Perceived change in average pain from baseline on a -10 to +10 (21-point) numeric rating scale
0, 6, 12, 24, 39, 52 weeks
Perceived headache improvement from baseline for cervicogenic headache
Time Frame: 0, 6, 12, 24, 39, 52 weeks
Perceived cervicogenic headache improvement from baseline on a 9-point Likert-like scale.
0, 6, 12, 24, 39, 52 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.
University of Western States

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.
National Center for Complementary and Integrative Health (NCCIH)

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.
  • Principal Investigator: Gert Bronfort, DC, PhD, University of Minnesota

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.
August 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, 2016

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, 2016

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).
February 2, 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.
February 6, 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.
February 9, 2012

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.
November 20, 2018

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 17, 2018

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, 2018

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.
  • R01AT006330 (U.S. NIH Grant/Contract)

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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