Cervicogenic Headache
Conditions
Keywords
cervicogenic headache, spinal manipulation, chiropractic, randomized controlled trial, dose-response, efficacy
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.
Interventions
OTHERSpinal Manipulation
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
OTHERLight Massage
5 minutes of light pressure massage to the neck and upper back
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Western States
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache days change from baseline for cervicogenic headache | 0, 6, 12, 24, 39, 52 weeks | Days with cervicogenic headache in the last four weeks from a daily headache diary. Change score = follow-up score - baseline score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average pain change from baseline for cervicogenic headache | 0, 6, 12, 24, 39, 52 weeks | 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. |
| Headache-related disability change from baseline for cervicogenic headaches | 0, 6, 12, 24, 39, 52 weeks | Headache Impact Test (HIT-6) |
| Headache-related disability days change from baseline | 0, 6, 12, 24, 39, 52 weeks | 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. |
| EuroQol-5D change from baseline | 0, 12, 24, 39, 52 weeks | Health-related quality of life |
| Average pain change from baseline for neck | 0, 6, 12, 24, 39, 52 weeks | Average neck pain in the last four weeks from recall. Pain is rated on a 0 to 11 numeric rating scale. |
| Neck pain days change from baseline | 0, 6, 12, 24, 39, 52 weeks | Number of days with neck pain in last 4 weeks from recall. |
| medication use change from baseline | 0, 6, 12, 24, 39, 52 weeks | Number days of use of prescription and nonprescription medications for headaches with neck pain |
| Outside Care change from baseline | 0, 6, 12, 24, 39, 52 weeks | Visits to providers outside the study for care of cervicogenic headache. Includes hospital and emergency room visits |
| Patient Satisfaction | week 12 | Likert scale for success of care |
| Objective biomechanical measures change from baseline | 0, 6 weeks | Measures of cervical joint function and kinematics including global range of motion, spinal segmental joint restriction, pain pressure thresholds |
| Quality-adjusted life years change from baseline | 0, 12, 24, 39, 52 weeks | utility for cost-effectiveness analysis |
| Direct & Indirect costs change from baseline | 0, 6, 12, 24, 39, 52 weeks | Health services; lost work days and productivity |
| Perceived headache average pain change from baseline for cervicogenic headache | 0, 6, 12, 24, 39, 52 weeks | Perceived change in average pain from baseline on a -10 to +10 (21-point) numeric rating scale |
| Perceived headache improvement from baseline for cervicogenic headache | 0, 6, 12, 24, 39, 52 weeks | Perceived cervicogenic headache improvement from baseline on a 9-point Likert-like scale. |
Countries
United States
Outcome results
None listed