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Cervicogenic Headache Dose-Response (CGH D-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530321
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Mitchell Haas, University of Western States

Tracking Information
First Submitted Date  ICMJE February 2, 2012
First Posted Date  ICMJE February 9, 2012
Last Update Posted Date November 20, 2018
Study Start Date  ICMJE August 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Modified Von Korff Pain Scale change from baseline for headache pain [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ]
Scale score = average of current pain, average pain in the last 4 weeks, and worst pain in the last 4 weeks normalized to a 100-point scale. Change score = follow-up score - baseline score
Change History Complete list of historical versions of study NCT01530321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
  • 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.
  • Headache-related disability change from baseline for cervicogenic headaches [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ]
    Headache Impact Test (HIT-6)
  • 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.
  • EuroQol-5D change from baseline [ Time Frame: 0, 12, 24, 39, 52 weeks ]
    Health-related quality of life
  • 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.
  • 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.
  • 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
  • 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
  • Patient Satisfaction [ Time Frame: week 12 ]
    Likert scale for success of care
  • 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
  • Quality-adjusted life years change from baseline [ Time Frame: 0, 12, 24, 39, 52 weeks ]
    utility for cost-effectiveness analysis
  • Direct & Indirect costs change from baseline [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ]
    Health services; lost work days and productivity
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
  • Modified Von Korff Disability Scale change from baseline for headache [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ]
  • Modified Von Korff Pain Scale change from baseline for neck pain [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ]
  • Modified Von Korff Disability Scale change from baseline for neck [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ]
  • EuroQol-5D change from baseline [ Time Frame: 0, 12, 24, 39, 52 weeks ]
    Health-related quality of life
  • Headache Number change from baseline [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ]
    Number of cervicogenic headaches in last four weeks
  • Disability days change from baseline [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ]
    Number of Disability days in last 4 weeks related to cervicogenic headache
  • headache days change from baseline [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ]
    Number of days with a cervicogenic headache in last four weeks
  • medication use change from baseline [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ]
    Number of times and days of use of prescription and nonprescription medications for headaches with neck pain
  • Outside Care change from baseline [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ]
    Visits to providers outside the study for care of cervicogenic headache. Includes hospital and emergency room visits
  • Patient Satisfaction [ Time Frame: week 12 ]
    Likert scale for success of care
  • 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
  • Quality-adjusted life years [ Time Frame: 0, 12, 24, 39, 52 weeks ]
    utility for cost-effectiveness analysis
  • Direct & Indirect costs [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ]
    Health services; lost work days and productivity
  • Headache Disability Inventory change from baseline [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ]
    25-item disability instrument
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervicogenic Headache Dose-Response
Official Title  ICMJE Dose-Response of Manipulation for Cervicogenic Headache
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervicogenic Headache
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: High dose spinal manipulation
    18 visits for spinal manipulation
    Intervention: Other: Spinal Manipulation
  • Experimental: Moderate dose spinal manipulation
    12 visits for spinal manipulation and 6 visits for light massage
    Interventions:
    • Other: Spinal Manipulation
    • Other: Light Massage
  • Experimental: Low dose spinal manipulation
    6 visits for spinal manipulation and 12 visits for light massage
    Interventions:
    • Other: Spinal Manipulation
    • Other: Light Massage
  • High dose massage
    18 visits for light massage
    Intervention: Other: Light Massage
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2012)
256
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530321
Other Study ID Numbers  ICMJE R01AT006330( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitchell Haas, University of Western States
Study Sponsor  ICMJE University of Western States
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Mitchell Haas, DC, MA University of Western States
Principal Investigator: Gert Bronfort, DC, PhD University of Minnesota
PRS Account University of Western States
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP