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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose spinal manipulation | Experimental | 18 visits for spinal manipulation |
|
| Moderate dose spinal manipulation | Experimental | 12 visits for spinal manipulation and 6 visits for light massage |
|
| Low dose spinal manipulation | Experimental | 6 visits for spinal manipulation and 12 visits for light massage |
|
| High dose massage | Other | 18 visits for light massage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Manipulation | Other | 5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 6, 12, 24, 39, 52 weeks |
| Headache-related disability change from baseline for cervicogenic headaches |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Haas, DC, MA | University of Western States | Principal Investigator |
| Gert Bronfort, DC, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Health Sciences University | Bloomington | Minnesota | 55431 | United States | ||
| University of Western States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27280016 | Background | 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. | |
| 29481979 | Result | 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. |
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Light Massage | Other | 5 minutes of light pressure massage to the neck and upper back |
|
Headache Impact Test (HIT-6) |
| 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. | 0, 6, 12, 24, 39, 52 weeks |
| EuroQol-5D change from baseline | Health-related quality of life | 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. | 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. | 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 | 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 | 0, 6, 12, 24, 39, 52 weeks |
| Patient Satisfaction | Likert scale for success of care | 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 | 0, 6 weeks |
| Quality-adjusted life years change from baseline | utility for cost-effectiveness analysis | 0, 12, 24, 39, 52 weeks |
| Direct & Indirect costs change from baseline | Health services; lost work days and productivity | 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 | 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. | 0, 6, 12, 24, 39, 52 weeks |
| Portland |
| Oregon |
| 97230 |
| United States |
| D009422 | Nervous System Diseases |