Cervicogenic Headache Dose-Response
CGH D-R
Dose-Response of Manipulation for Cervicogenic Headache
1 other identifier
interventional
256
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2012
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedNovember 20, 2018
November 1, 2018
4 years
February 2, 2012
November 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
0, 6, 12, 24, 39, 52 weeks
Secondary Outcomes (14)
Average pain change from baseline for cervicogenic headache
0, 6, 12, 24, 39, 52 weeks
Headache-related disability change from baseline for cervicogenic headaches
0, 6, 12, 24, 39, 52 weeks
Headache-related disability days change from baseline
0, 6, 12, 24, 39, 52 weeks
EuroQol-5D change from baseline
0, 12, 24, 39, 52 weeks
Average pain change from baseline for neck
0, 6, 12, 24, 39, 52 weeks
- +9 more secondary outcomes
Study Arms (4)
High dose spinal manipulation
EXPERIMENTAL18 visits for spinal manipulation
Moderate dose spinal manipulation
EXPERIMENTAL12 visits for spinal manipulation and 6 visits for light massage
Low dose spinal manipulation
EXPERIMENTAL6 visits for spinal manipulation and 12 visits for light massage
High dose massage
OTHER18 visits for light massage
Interventions
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
5 minutes of light pressure massage to the neck and upper back
Eligibility Criteria
You may qualify if:
- chronic cervicogenic headache
- threshold pain level
- threshold headache frequency
- independently ambulatory
- English literate
- candidate for spinal manipulation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Northwestern Health Sciences University
Bloomington, Minnesota, 55431, United States
University of Western States
Portland, Oregon, 97230, United States
Related Publications (2)
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.
PMID: 27280016BACKGROUNDHaas 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.
PMID: 29481979RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell Haas, DC, MA
University of Western States
- PRINCIPAL INVESTIGATOR
Gert Bronfort, DC, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Vice President of Research
Study Record Dates
First Submitted
February 2, 2012
First Posted
February 9, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
November 20, 2018
Record last verified: 2018-11