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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
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
Northwestern Health Sciences University
Bloomington, Minnesota, United States
University of Western States
Portland, Oregon, United States
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)
Time frame: 0, 6, 12, 24, 39, 52 weeks
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.
Time frame: 0, 6, 12, 24, 39, 52 weeks
Headache-related disability change from baseline for cervicogenic headaches
Headache Impact Test (HIT-6)
Time frame: 0, 6, 12, 24, 39, 52 weeks
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.
Time frame: 0, 6, 12, 24, 39, 52 weeks
EuroQol-5D change from baseline
Health-related quality of life
Time frame: 0, 12, 24, 39, 52 weeks
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.
Time frame: 0, 6, 12, 24, 39, 52 weeks
Neck pain days change from baseline
Number of days with neck pain in last 4 weeks from recall.
Time frame: 0, 6, 12, 24, 39, 52 weeks
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medication use change from baseline
Number days of use of prescription and nonprescription medications for headaches with neck pain
Time frame: 0, 6, 12, 24, 39, 52 weeks
Outside Care change from baseline
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
Patient Satisfaction
Likert scale for success of care
Time frame: week 12
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
Time frame: 0, 6 weeks
Quality-adjusted life years change from baseline
utility for cost-effectiveness analysis
Time frame: 0, 12, 24, 39, 52 weeks
Direct & Indirect costs change from baseline
Health services; lost work days and productivity
Time frame: 0, 6, 12, 24, 39, 52 weeks
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
Time frame: 0, 6, 12, 24, 39, 52 weeks
Perceived headache improvement from baseline for cervicogenic headache
Perceived cervicogenic headache improvement from baseline on a 9-point Likert-like scale.
Time frame: 0, 6, 12, 24, 39, 52 weeks