Cervicogenic Headache Dose-Response

Cervicogenic Headache Clinical Trial

— CGH D-R  

Official title:

Dose-Response of Manipulation for Cervicogenic Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530321
• Other study ID #: R01AT006330
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2012
• Est. completion date: August 2016

Study information

• Verified date: November 2018
• Source: University of Western States
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache

Intervention

Other:
• Spinal Manipulation
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
• Light Massage
5 minutes of light pressure massage to the neck and upper back

Locations

Country	Name	City	State
United States	Northwestern Health Sciences University	Bloomington	Minnesota
United States	University of Western States	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Western States	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Feb 23. pii: S152 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Headache-related disability change from baseline for cervicogenic headaches	Headache Impact Test (HIT-6)	0, 6, 12, 24, 39, 52 weeks
Secondary	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
Secondary	EuroQol-5D change from baseline	Health-related quality of life	0, 12, 24, 39, 52 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient Satisfaction	Likert scale for success of care	week 12
Secondary	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
Secondary	Quality-adjusted life years change from baseline	utility for cost-effectiveness analysis	0, 12, 24, 39, 52 weeks
Secondary	Direct & Indirect costs change from baseline	Health services; lost work days and productivity	0, 6, 12, 24, 39, 52 weeks
Secondary	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
Secondary	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