A Phase 1/2 interventional study of Spinal Manipulation and Light Massage in Cervicogenic Headache, sponsored by University of Western States. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by University of Western States · Phase 1/2, Interventional, and Treatment
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.
188 studies on the registry are indexed under Post-Traumatic Headache; 50 are open to participants now.
This study's enrollment of 256 is above the median of 44 across 166 interventional studies indexed under Post-Traumatic Headache.
Browse Post-Traumatic Headache studies →University of Western States is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
18 visits for spinal manipulation
Other: Spinal Manipulation
12 visits for spinal manipulation and 6 visits for light massage
Other: Spinal Manipulation · Other: Light Massage
6 visits for spinal manipulation and 12 visits for light massage
Other: Spinal Manipulation · Other: Light Massage
18 visits for light massage
Other: Light Massage
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
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
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
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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University of Western States