Cervicogenic Headache Dose-Response
- Conditions
- Cervicogenic Headache
- Interventions
- Other: Spinal ManipulationOther: Light Massage
- Registration Number
- NCT01530321
- Lead Sponsor
- University of Western States
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
- chronic cervicogenic headache
- threshold pain level
- threshold headache frequency
- independently ambulatory
- English literate
- candidate for spinal manipulation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose spinal manipulation Light Massage 6 visits for spinal manipulation and 12 visits for light massage High dose massage Light Massage 18 visits for light massage High dose spinal manipulation Spinal Manipulation 18 visits for spinal manipulation Moderate dose spinal manipulation Light Massage 12 visits for spinal manipulation and 6 visits for light massage Moderate dose spinal manipulation Spinal Manipulation 12 visits for spinal manipulation and 6 visits for light massage Low dose spinal manipulation Spinal Manipulation 6 visits for spinal manipulation and 12 visits for light massage
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method EuroQol-5D change from baseline 0, 12, 24, 39, 52 weeks Health-related quality of life
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
Quality-adjusted life years change from baseline 0, 12, 24, 39, 52 weeks utility for cost-effectiveness analysis
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.
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
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.
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
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
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)
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.
Patient Satisfaction week 12 Likert scale for success of care
Direct & Indirect costs change from baseline 0, 6, 12, 24, 39, 52 weeks Health services; lost work days and productivity
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.
Trial Locations
- Locations (2)
Northwestern Health Sciences University
🇺🇸Bloomington, Minnesota, United States
University of Western States
🇺🇸Portland, Oregon, United States