Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
256 participants
INTERVENTIONAL
2012-08-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High dose spinal manipulation
18 visits for spinal manipulation
Spinal Manipulation
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
Moderate dose spinal manipulation
12 visits for spinal manipulation and 6 visits for light massage
Spinal Manipulation
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
Light Massage
5 minutes of light pressure massage to the neck and upper back
Low dose spinal manipulation
6 visits for spinal manipulation and 12 visits for light massage
Spinal Manipulation
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
Light Massage
5 minutes of light pressure massage to the neck and upper back
High dose massage
18 visits for light massage
Light Massage
5 minutes of light pressure massage to the neck and upper back
Interventions
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Spinal Manipulation
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
Light Massage
5 minutes of light pressure massage to the neck and upper back
Eligibility Criteria
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Inclusion Criteria
* threshold pain level
* threshold headache frequency
* independently ambulatory
* English literate
* candidate for spinal manipulation
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of Western States
OTHER
Responsible Party
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Mitchell Haas
Associate Vice President of Research
Principal Investigators
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Mitchell Haas, DC, MA
Role: PRINCIPAL_INVESTIGATOR
University of Western States
Gert Bronfort, DC, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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Northwestern Health Sciences University
Bloomington, Minnesota, United States
University of Western States
Portland, Oregon, United States
Countries
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References
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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.
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.
Other Identifiers
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