Cervicogenic Headache Dose-Response (CGH D-R)
Primary Purpose
Cervicogenic Headache
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Spinal Manipulation
Light Massage
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Headache focused on measuring cervicogenic headache, spinal manipulation, chiropractic, randomized controlled trial, dose-response, efficacy
Eligibility 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
Sites / Locations
- Northwestern Health Sciences University
- University of Western States
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
High dose spinal manipulation
Moderate dose spinal manipulation
Low dose spinal manipulation
High dose massage
Arm Description
18 visits for spinal manipulation
12 visits for spinal manipulation and 6 visits for light massage
6 visits for spinal manipulation and 12 visits for light massage
18 visits for light massage
Outcomes
Primary Outcome Measures
Headache days change from baseline for cervicogenic headache
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
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
Headache Impact Test (HIT-6)
Headache-related disability days change from baseline
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
Health-related quality of life
Average pain change from baseline for neck
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
Number of days with neck pain in last 4 weeks from recall.
medication use change from baseline
Number days of use of prescription and nonprescription medications for headaches with neck pain
Outside Care change from baseline
Visits to providers outside the study for care of cervicogenic headache. Includes hospital and emergency room visits
Patient Satisfaction
Likert scale for success of care
Objective biomechanical measures change from baseline
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
utility for cost-effectiveness analysis
Direct & Indirect costs change from baseline
Health services; lost work days and productivity
Perceived headache average pain change from baseline for cervicogenic headache
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
Perceived cervicogenic headache improvement from baseline on a 9-point Likert-like scale.
Full Information
NCT ID
NCT01530321
First Posted
February 2, 2012
Last Updated
November 17, 2018
Sponsor
University of Western States
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01530321
Brief Title
Cervicogenic Headache Dose-Response
Acronym
CGH D-R
Official Title
Dose-Response of Manipulation for Cervicogenic Headache
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western States
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
cervicogenic headache, spinal manipulation, chiropractic, randomized controlled trial, dose-response, efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High dose spinal manipulation
Arm Type
Experimental
Arm Description
18 visits for spinal manipulation
Arm Title
Moderate dose spinal manipulation
Arm Type
Experimental
Arm Description
12 visits for spinal manipulation and 6 visits for light massage
Arm Title
Low dose spinal manipulation
Arm Type
Experimental
Arm Description
6 visits for spinal manipulation and 12 visits for light massage
Arm Title
High dose massage
Arm Type
Other
Arm Description
18 visits for light massage
Intervention Type
Other
Intervention Name(s)
Spinal Manipulation
Intervention Description
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
Intervention Type
Other
Intervention Name(s)
Light Massage
Intervention Description
5 minutes of light pressure massage to the neck and upper back
Primary Outcome Measure Information:
Title
Headache days change from baseline for cervicogenic headache
Description
Days with cervicogenic headache in the last four weeks from a daily headache diary. Change score = follow-up score - baseline score)
Time Frame
0, 6, 12, 24, 39, 52 weeks
Secondary Outcome Measure Information:
Title
Average pain change from baseline for cervicogenic headache
Description
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.
Time Frame
0, 6, 12, 24, 39, 52 weeks
Title
Headache-related disability change from baseline for cervicogenic headaches
Description
Headache Impact Test (HIT-6)
Time Frame
0, 6, 12, 24, 39, 52 weeks
Title
Headache-related disability days change from baseline
Description
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.
Time Frame
0, 6, 12, 24, 39, 52 weeks
Title
EuroQol-5D change from baseline
Description
Health-related quality of life
Time Frame
0, 12, 24, 39, 52 weeks
Title
Average pain change from baseline for neck
Description
Average neck pain in the last four weeks from recall. Pain is rated on a 0 to 11 numeric rating scale.
Time Frame
0, 6, 12, 24, 39, 52 weeks
Title
Neck pain days change from baseline
Description
Number of days with neck pain in last 4 weeks from recall.
Time Frame
0, 6, 12, 24, 39, 52 weeks
Title
medication use change from baseline
Description
Number days of use of prescription and nonprescription medications for headaches with neck pain
Time Frame
0, 6, 12, 24, 39, 52 weeks
Title
Outside Care change from baseline
Description
Visits to providers outside the study for care of cervicogenic headache. Includes hospital and emergency room visits
Time Frame
0, 6, 12, 24, 39, 52 weeks
Title
Patient Satisfaction
Description
Likert scale for success of care
Time Frame
week 12
Title
Objective biomechanical measures change from baseline
Description
Measures of cervical joint function and kinematics including global range of motion, spinal segmental joint restriction, pain pressure thresholds
Time Frame
0, 6 weeks
Title
Quality-adjusted life years change from baseline
Description
utility for cost-effectiveness analysis
Time Frame
0, 12, 24, 39, 52 weeks
Title
Direct & Indirect costs change from baseline
Description
Health services; lost work days and productivity
Time Frame
0, 6, 12, 24, 39, 52 weeks
Title
Perceived headache average pain change from baseline for cervicogenic headache
Description
Perceived change in average pain from baseline on a -10 to +10 (21-point) numeric rating scale
Time Frame
0, 6, 12, 24, 39, 52 weeks
Title
Perceived headache improvement from baseline for cervicogenic headache
Description
Perceived cervicogenic headache improvement from baseline on a 9-point Likert-like scale.
Time Frame
0, 6, 12, 24, 39, 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Haas, DC, MA
Organizational Affiliation
University of Western States
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gert Bronfort, DC, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Health Sciences University
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
University of Western States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97230
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27280016
Citation
Hanson L, Haas M, Bronfort G, Vavrek D, Schulz C, Leininger B, Evans R, Takaki L, Neradilek M. Dose-response of spinal manipulation for cervicogenic headache: study protocol for a randomized controlled trial. Chiropr Man Therap. 2016 Jun 8;24:23. doi: 10.1186/s12998-016-0105-z. eCollection 2016.
Results Reference
background
PubMed Identifier
29481979
Citation
Haas M, Bronfort G, Evans R, Schulz C, Vavrek D, Takaki L, Hanson L, Leininger B, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of cervicogenic headache: a dual-center randomized controlled trial. Spine J. 2018 Oct;18(10):1741-1754. doi: 10.1016/j.spinee.2018.02.019. Epub 2018 Feb 23.
Results Reference
result
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Cervicogenic Headache Dose-Response
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