Cervicogenic HeadachePhase 1/2CGH D-RNCT01530321
Cervicogenic Headache Dose-Response
A Phase 1/2 study testing Spinal Manipulation and Light Massage in people with Cervicogenic Headache, run by University of Western States at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Spinal Manipulation and Light Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Aug 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic cervicogenic headache
- threshold pain level
- threshold headache frequency
- independently ambulatory
- English literate
- candidate for spinal manipulation
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Health Sciences University
Bloomington, Minnesota, 55431
University of Western States
Portland, Oregon, 97230
About this study
Official title: 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.
- Conditions
- Cervicogenic Headache
- Being tested
- Spinal Manipulation, Light Massage
- Keywords
- cervicogenic headache, spinal manipulation, chiropractic, randomized controlled trial, dose-response, efficacy
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationOther
5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
Light MassageOther
5 minutes of light pressure massage to the neck and upper back
| Study group | Role | What they receive |
|---|---|---|
| High dose spinal manipulation | Experimental | 18 visits for spinal manipulation Receives: Other: Spinal Manipulation |
| Moderate dose spinal manipulation | Experimental | 12 visits for spinal manipulation and 6 visits for light massage Receives: Other: Spinal Manipulation; Other: Light Massage |
| Low dose spinal manipulation | Experimental | 6 visits for spinal manipulation and 12 visits for light massage Receives: Other: Spinal Manipulation; Other: Light Massage |
| High dose massage | Other | 18 visits for light massage Receives: Other: Light Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0, 6, 12, 24, 39, 52 weeks
Secondary outcomes (14)
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.
Measured: 0, 6, 12, 24, 39, 52 weeks
Headache-related disability change from baseline for cervicogenic headaches
Headache Impact Test (HIT-6)
Measured: 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.
Measured: 0, 6, 12, 24, 39, 52 weeks
EuroQol-5D change from baseline
Health-related quality of life
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 0, 6, 12, 24, 39, 52 weeks
Patient Satisfaction
Likert scale for success of care
Measured: 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
Measured: 0, 6 weeks
Quality-adjusted life years change from baseline
utility for cost-effectiveness analysis
Measured: 0, 12, 24, 39, 52 weeks
Direct & Indirect costs change from baseline
Health services; lost work days and productivity
Measured: 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
Measured: 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.
Measured: 0, 6, 12, 24, 39, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western States
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Mitchell Haas, University of Western States
- Investigators
- Mitchell Haas, DC, MA, Principal investigator, University of Western StatesGert Bronfort, DC, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530321
- Sponsor's protocol ID
- R01AT006330
- Acronym
- CGH D-R
- Status last verified
- Nov 2018
- First submitted
- 2 Feb 2012
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 27280016Haas 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.
PubMed 29481979
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response of Manipulation for Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT01530321
- Acronym / sponsor ID
- CGH D-R / R01AT006330
- Conditions
- Cervicogenic Headache
- Keywords
- cervicogenic headache, spinal manipulation, chiropractic, randomized controlled trial, dose-response, efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of Western StatesUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High dose spinal manipulation | Experimental | Other: Spinal Manipulation18 visits for spinal manipulation |
| Moderate dose spinal manipulation | Experimental | Other: Spinal Manipulation, Other: Light Massage12 visits for spinal manipulation and 6 visits for light massage |
| Low dose spinal manipulation | Experimental | Other: Spinal Manipulation, Other: Light Massage6 visits for spinal manipulation and 12 visits for light massage |
| High dose massage | Other | Other: Light Massage18 visits for light massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- chronic cervicogenic headache
- threshold pain level
- threshold headache frequency
- independently ambulatory
- English literate
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Manipulation5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine. | Other | High dose spinal manipulation, Low dose spinal manipulation, Moderate dose spinal manipulation |
| Light Massage5 minutes of light pressure massage to the neck and upper back | Other | High dose massage, Low dose spinal manipulation, Moderate dose spinal manipulation |
Primary outcome
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)
14 secondary outcomes
Average pain change from baseline for cervicogenic headache
Time frame: 0, 6, 12, 24, 39, 52 weeks
Headache-related disability change from baseline for cervicogenic headaches
Time frame: 0, 6, 12, 24, 39, 52 weeks
Headache-related disability days change from baseline
Time frame: 0, 6, 12, 24, 39, 52 weeks
EuroQol-5D change from baseline
Time frame: 0, 12, 24, 39, 52 weeks
Average pain change from baseline for neck
Time frame: 0, 6, 12, 24, 39, 52 weeks
Neck pain days change from baseline
Time frame: 0, 6, 12, 24, 39, 52 weeks
medication use change from baseline
Time frame: 0, 6, 12, 24, 39, 52 weeks
Outside Care change from baseline
Time frame: 0, 6, 12, 24, 39, 52 weeks
Patient Satisfaction
Time frame: week 12
Objective biomechanical measures change from baseline
Time frame: 0, 6 weeks
Quality-adjusted life years change from baseline
Time frame: 0, 12, 24, 39, 52 weeks
Direct & Indirect costs change from baseline
Time frame: 0, 6, 12, 24, 39, 52 weeks
Perceived headache average pain change from baseline for cervicogenic headache
Time frame: 0, 6, 12, 24, 39, 52 weeks
Perceived headache improvement from baseline for cervicogenic headache
Time frame: 0, 6, 12, 24, 39, 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Background: PubMed 27280016Hanson 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.
- Results publication: PubMed 29481979Haas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Haas, DC, MA principal investigator
University of Western States
Gert Bronfort, DC, PhD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Spinal Manipulation and Light Massage in people with Cervicogenic Headache, run by University of Western States at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache days change from baseline for cervicogenic headache (time frame: 0, 6, 12, 24, 39, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01530321, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.