Dose-Response of Manipulation for Cervicogenic Headache

University of Western States2 sites in 1 country256 target enrollmentAugust 2012

ConditionsCervicogenic Headache

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cervicogenic Headache
Sponsor: University of Western States
Enrollment: 256
Locations: 2
Primary Endpoint: Headache days change from baseline for cervicogenic headache
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

August 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Western States

Responsible Party

Principal Investigator

Mitchell Haas

Associate Vice President of Research

University of Western States

Eligibility Criteria

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

Outcomes

Primary Outcomes

Headache days change from baseline for cervicogenic headache

Time Frame: 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 Outcomes

Outside Care change from baseline(0, 6, 12, 24, 39, 52 weeks)
Quality-adjusted life years change from baseline(0, 12, 24, 39, 52 weeks)
EuroQol-5D change from baseline(0, 12, 24, 39, 52 weeks)
Neck pain days change from baseline(0, 6, 12, 24, 39, 52 weeks)
Objective biomechanical measures change from baseline(0, 6 weeks)
Headache-related disability days change from baseline(0, 6, 12, 24, 39, 52 weeks)
medication use change from baseline(0, 6, 12, 24, 39, 52 weeks)
Perceived headache average pain change from baseline for cervicogenic headache(0, 6, 12, 24, 39, 52 weeks)
Average pain change from baseline for cervicogenic headache(0, 6, 12, 24, 39, 52 weeks)
Headache-related disability change from baseline for cervicogenic headaches(0, 6, 12, 24, 39, 52 weeks)
Average pain change from baseline for neck(0, 6, 12, 24, 39, 52 weeks)
Patient Satisfaction(week 12)
Direct & Indirect costs change from baseline(0, 6, 12, 24, 39, 52 weeks)
Perceived headache improvement from baseline for cervicogenic headache(0, 6, 12, 24, 39, 52 weeks)