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Cervicogenic Headache Dose-Response (CGH D-R)

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ClinicalTrials.gov Identifier: NCT01530321
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : September 8, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervicogenic Headache Other: Spinal Manipulation Other: Light Massage Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose-Response of Manipulation for Cervicogenic Headache
Study Start Date : August 2012
Primary Completion Date : August 2016
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
High dose massage
18 visits for light massage
Other: Light Massage
5 minutes of light pressure massage to the neck and upper back


Outcome Measures

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. Headache-related disability change from baseline for cervicogenic headaches [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ]
    Headache Impact Test (HIT-6)

  3. 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.

  4. EuroQol-5D change from baseline [ Time Frame: 0, 12, 24, 39, 52 weeks ]
    Health-related quality of life

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. Patient Satisfaction [ Time Frame: week 12 ]
    Likert scale for success of care

  10. 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

  11. Quality-adjusted life years change from baseline [ Time Frame: 0, 12, 24, 39, 52 weeks ]
    utility for cost-effectiveness analysis

  12. Direct & Indirect costs change from baseline [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ]
    Health services; lost work days and productivity

  13. 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

  14. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530321


Locations
United States, Minnesota
Northwestern Health Sciences University
Bloomington, Minnesota, United States, 55431
United States, Oregon
University of Western States
Portland, Oregon, United States, 97230
Sponsors and Collaborators
University of Western States
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Mitchell Haas, DC, MA University of Western States
Principal Investigator: Gert Bronfort, DC, PhD University of Minnesota - Clinical and Translational Science Institute
More Information

Publications:
Responsible Party: Mitchell Haas, Associate Vice President of Research, University of Western States
ClinicalTrials.gov Identifier: NCT01530321     History of Changes
Other Study ID Numbers: R01AT006330 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by Mitchell Haas, University of Western States:
cervicogenic headache
spinal manipulation
chiropractic
randomized controlled trial
dose-response
efficacy

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases