Clinical trial NCT01530321: Cervicogenic Headache Dose-Response
Official title: Dose-Response of Manipulation for Cervicogenic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervicogenic Headache
Keywords: cervicogenic headache
spinal manipulation
chiropractic
randomized controlled trial
dose-response
efficacy
Lead sponsor: University of Western States
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2012-02-09
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Headache days change from baseline for cervicogenic headache
timeFrame: 0, 6, 12, 24, 39, 52 weeks
Secondary outcomes:
measure: Average pain change from baseline for cervicogenic headache
timeFrame: 0, 6, 12, 24, 39, 52 weeks
measure: Headache-related disability change from baseline for cervicogenic headaches
timeFrame: 0, 6, 12, 24, 39, 52 weeks
measure: Headache-related disability days change from baseline
timeFrame: 0, 6, 12, 24, 39, 52 weeks
measure: EuroQol-5D change from baseline
timeFrame: 0, 12, 24, 39, 52 weeks
measure: Average pain change from baseline for neck
timeFrame: 0, 6, 12, 24, 39, 52 weeks
measure: Neck pain days change from baseline
timeFrame: 0, 6, 12, 24, 39, 52 weeks
measure: medication use change from baseline
timeFrame: 0, 6, 12, 24, 39, 52 weeks
measure: Outside Care change from baseline
timeFrame: 0, 6, 12, 24, 39, 52 weeks
measure: Patient Satisfaction
timeFrame: week 12
measure: Objective biomechanical measures change from baseline
timeFrame: 0, 6 weeks
measure: Quality-adjusted life years change from baseline
timeFrame: 0, 12, 24, 39, 52 weeks
measure: Direct & Indirect costs change from baseline
timeFrame: 0, 6, 12, 24, 39, 52 weeks
measure: Perceived headache average pain change from baseline for cervicogenic headache
timeFrame: 0, 6, 12, 24, 39, 52 weeks
measure: Perceived headache improvement from baseline for cervicogenic headache
timeFrame: 0, 6, 12, 24, 39, 52 weeks
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Northwestern Health Sciences University
state: Minnesota
city: Portland
country: United States
facility: University of Western States
state: Oregon
Study officials:
affiliation: University of Western States
name: Mitchell Haas, DC, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Gert Bronfort, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.