Cervicogenic Headache Dose-Response (CGH D-R)

Dose-Response of Manipulation for Cervicogenic Headache

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.

Study Overview

• Status: Completed
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Other: Spinal Manipulation; Other: Light Massage

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Northwestern Health Sciences University
  • Oregon
    • Portland, Oregon, United States, 97230
      • University of Western States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose spinal manipulation; 18 visits for spinal manipulation	Other: Spinal Manipulation; 5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
Experimental: Moderate dose spinal manipulation; 12 visits for spinal manipulation and 6 visits for light massage	Other: Spinal Manipulation; 5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.; Other: Light Massage; 5 minutes of light pressure massage to the neck and upper back
Experimental: Low dose spinal manipulation; 6 visits for spinal manipulation and 12 visits for light massage	Other: Spinal Manipulation; 5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.; Other: Light Massage; 5 minutes of light pressure massage to the neck and upper back
Other: High dose massage; 18 visits for light massage	Other: Light Massage; 5 minutes of light pressure massage to the neck and upper back

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Western States
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Gert Bronfort, DC, PhD, University of Minnesota

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: February 2, 2012
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 9, 2012

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 17, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: randomized controlled trial; spinal manipulation; efficacy; dose-response; chiropractic; cervicogenic headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: R01AT006330 (U.S. NIH Grant/Contract)