Cervicogenic Headache Dose-Response (CGH D-R)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 6, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Cervicogenic Headache
Other: Spinal Manipulation
Other: Light Massage
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-Response of Manipulation for Cervicogenic Headache

Resource links provided by NLM:


Further study details as provided by University of Western States:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 256
Study Start Date: August 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530321

Locations
United States, Minnesota
Northwestern Health Sciences University Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Linda Hanson, DC    800-888-4777 ext 316    lhanson@nwhealth.edu   
Principal Investigator: Gert Bronfort, DC, PhD         
Sub-Investigator: Roni Evans, DC, MS         
Sub-Investigator: Craig Schultz, DC, MS         
United States, Oregon
University of Western States Recruiting
Portland, Oregon, United States, 97230
Contact: Leslie Takaki, BS, MS    800-678-9072    Ltakaki@uws.edu   
Principal Investigator: Mitchell Haas, DC, MA         
Sub-Investigator: Darcy Vavrek, ND, MS         
Sub-Investigator: David Peterson, DC         
Sponsors and Collaborators
University of Western States
Investigators
Principal Investigator: Mitchell Haas, DC, MA University of Western States
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
  More Information

No publications provided

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
Study First Received: February 2, 2012
Last Updated: June 6, 2014
Health Authority: United States: Federal Government

Keywords provided by 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

ClinicalTrials.gov processed this record on July 31, 2014