Trial record 1 of 2 for:    Dose-Response of Manipulation for Cervicogenic Headache
Previous Study | Return to List | Next Study

Cervicogenic Headache Dose-Response (CGH D-R)

This study is currently recruiting participants.
Verified May 2013 by University of Western States
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mitchell Haas, University of Western States
ClinicalTrials.gov Identifier:
NCT01530321
First received: February 2, 2012
Last updated: May 3, 2013
Last verified: May 2013

February 2, 2012
May 3, 2013
August 2012
March 2015   (final data collection date for primary outcome measure)
Headache days change from baseline for cervicogenic headache [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Days with cervicogenic headache in the last four weeks from a daily headache diary. Change score = follow-up score - baseline score)
Modified Von Korff Pain Scale change from baseline for headache pain [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01530321 on ClinicalTrials.gov Archive Site
  • Average pain change from baseline for cervicogenic headache [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Headache Impact Test (HIT-6)
  • Headache-related disability days change from baseline [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Health-related quality of life
  • Average pain change from baseline for neck [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Visits to providers outside the study for care of cervicogenic headache. Includes hospital and emergency room visits
  • Patient Satisfaction [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Likert scale for success of care
  • Objective biomechanical measures change from baseline [ Time Frame: 0, 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    utility for cost-effectiveness analysis
  • Direct & Indirect costs change from baseline [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Perceived cervicogenic headache improvement from baseline on a 9-point Likert-like scale.
  • Modified Von Korff Disability Scale change from baseline for headache [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Modified Von Korff Pain Scale change from baseline for neck pain [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Modified Von Korff Disability Scale change from baseline for neck [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • EuroQol-5D change from baseline [ Time Frame: 0, 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
    Health-related quality of life
  • Headache Number change from baseline [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
    Number of cervicogenic headaches in last four weeks
  • Disability days change from baseline [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Visits to providers outside the study for care of cervicogenic headache. Includes hospital and emergency room visits
  • Patient Satisfaction [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Likert scale for success of care
  • Objective biomechanical measures change from baseline [ Time Frame: 0, 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    utility for cost-effectiveness analysis
  • Direct & Indirect costs [ Time Frame: 0, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
    Health services; lost work days and productivity
  • Headache Disability Inventory change from baseline [ Time Frame: 0, 6, 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
    25-item disability instrument
Not Provided
Not Provided
 
Cervicogenic Headache Dose-Response
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervicogenic Headache
  • 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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
256
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT01530321
R01AT006330
Yes
Mitchell Haas, University of Western States
University of Western States
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Mitchell Haas, DC, MA University of Western States
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
University of Western States
May 2013

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