Cervicogenic Headache Dose-Response

NCT ID: NCT01530321

Last Updated: 2018-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Cervicogenic Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High dose spinal manipulation

18 visits for spinal manipulation

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type OTHER

5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.

Moderate dose spinal manipulation

12 visits for spinal manipulation and 6 visits for light massage

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type OTHER

5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.

Light Massage

Intervention Type OTHER

5 minutes of light pressure massage to the neck and upper back

Low dose spinal manipulation

6 visits for spinal manipulation and 12 visits for light massage

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type OTHER

5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.

Light Massage

Intervention Type OTHER

5 minutes of light pressure massage to the neck and upper back

High dose massage

18 visits for light massage

Group Type OTHER

Light Massage

Intervention Type OTHER

5 minutes of light pressure massage to the neck and upper back

Interventions

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Spinal Manipulation

5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.

Intervention Type OTHER

Light Massage

5 minutes of light pressure massage to the neck and upper back

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Western States

OTHER

Sponsor Role lead

Responsible Party

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Mitchell Haas

Associate Vice President of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mitchell Haas, DC, MA

Role: PRINCIPAL_INVESTIGATOR

University of Western States

Gert Bronfort, DC, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Northwestern Health Sciences University

Bloomington, Minnesota, United States

Site Status

University of Western States

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27280016 (View on PubMed)

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.

Reference Type RESULT
PMID: 29481979 (View on PubMed)

Other Identifiers

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R01AT006330

Identifier Type: NIH

Identifier Source: org_study_id

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