Cervicogenic HeadachePhase 2/3NCT01509326
Chiropractic and Acupressure for Headaches
A Phase 2/3 study testing chiropractic treatment and Dr. Zaxx pillow in people with Cervicogenic Headache and Tension-type Headache, run by Canadian Memorial Chiropractic College at 1 site in Canada.
Trial summary
This study will investigate the effect of chiropractic treatment with and without the use of an acupressure pillow for cervical headaches. Subjects will be randomly allocated to groups with and without the pillow and will be followed for five weeks. The primary outcome measure will be headache frequency. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervicogenic Headache, Tension-type Headache, Migraine Headache
- What is being tested?
- chiropractic treatment and Dr. Zaxx pillow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Nov 2012
- Phase
- Phase 2/3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- males and females
- ages 21-60
- recurrent headaches
- sub-occipital tenderness
- a minimum of 4 headaches per month
Who cannot join
- migraine with aura
- sinus headache
- any other organic pathology
- any contraindications to cervical manipulation
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Canadian Memorial Chiropractic College
Toronto, Ontario, M2H 3J1
Mark Fillery, BA, 416-482-2340 ext. 267, mfillery@cmcc.ca
Howard Vernon, DC, PhD
About this study
Official title: A Randomized Clinical Trial of Chiropractic Care for Headaches With and Without an Acupressure Device
This study will investigate the effect of chiropractic treatment with and without the use of an acupressure pillow for cervical headaches. Subjects will be randomly allocated to groups with and without the pillow and will be followed for five weeks. The primary outcome measure will be headache frequency. The investigators predict that the group using the pillow on a daily basis will demonstrate significantly greater decrease in headache frequency over a 5-week interval.
- Being tested
- chiropractic treatment, Dr. Zaxx pillow
- Keywords
- headache, chiropractic, manipulation, acupressure, self-care
- Medical subject headings
- Post-Traumatic Headache, Tension-Type Headache, Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chiropractic treatmentOther
12 sessions over 4 weeks
Dr. Zaxx pillowDevice
Daily use of an acupressure pillow
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic | Active comparator | spinal manipulation, mobilization, massage, advice, exercises Receives: Other: chiropractic treatment |
| Chiropractic PLUS pillow | Experimental | spinal manipulation, mobilization, massage, advice, exercises, pillow Receives: Device: Dr. Zaxx pillow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency from a Headache Diary
Daily Headache Diary
Measured: change from baseline in headache frequency at 5 weeks
Secondary outcomes (3)
Headache disability
Headache Disability Index
Measured: baseline / end of treatment (5 weeks)
Treatment satisfaction
Small scale for rating satisfaction with treatment
Measured: end of treatment (5 weeks)
Adverse events
pain, stiffness, dizziness
Measured: up to five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Zaxx Co.
- Responsible party
- Principal investigator, Howard Vernon, Canadian Memorial Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509326
- Sponsor's protocol ID
- 112049
- Status last verified
- Jan 2012
- First submitted
- 4 Jan 2012
- Last updated
- 13 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Vernon H, Jansz G, Goldsmith CH, McDermaid C. A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial. J Manipulative Physiol Ther. 2009 Jun;32(5):344-51. doi: 10.1016/j.jmpt.2009.04.004.
PubMed 19539116
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Chiropractic Care for Headaches With and Without an Acupressure Device
- ClinicalTrials.gov ID
- NCT01509326
- Acronym / sponsor ID
- 112049
- Keywords
- headache, chiropractic, manipulation, acupressure, self-care
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Collaborators
- Dr. Zaxx Co.
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 13 Jan 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 investigate the effect of chiropractic treatment with and without the use of an acupressure pillow for cervical headaches. Subjects will be randomly allocated to groups with and without the pillow and will be followed for five weeks. The primary outcome measure will be headache frequency. The investigators predict that the group using the pillow on a daily basis will demonstrate significantly greater decrease in headache frequency over a 5-week interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic | Active comparator | Other: chiropractic treatmentspinal manipulation, mobilization, massage, advice, exercises |
| Chiropractic PLUS pillow | Experimental | Device: Dr. Zaxx pillowspinal manipulation, mobilization, massage, advice, exercises, pillow |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- males and females
- ages 21-60
- recurrent headaches
- sub-occipital tenderness
- a minimum of 4 headaches per month
Key exclusion criteria (4 listed)
- migraine with aura
- sinus headache
- any other organic pathology
- any contraindications to cervical manipulation
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 |
|---|---|---|
| chiropractic treatment12 sessions over 4 weeks | Other | Chiropractic |
| Dr. Zaxx pillowDaily use of an acupressure pillow | Device | Chiropractic PLUS pillow |
Primary outcome
Headache frequency from a Headache Diary
Time frame: change from baseline in headache frequency at 5 weeks
Daily Headache Diary
3 secondary outcomes
Headache disability
Time frame: baseline / end of treatment (5 weeks)
Treatment satisfaction
Time frame: end of treatment (5 weeks)
Adverse events
Time frame: up to five weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
- Background: PubMed 19539116Vernon H, Jansz G, Goldsmith CH, McDermaid C. A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial. J Manipulative Physiol Ther. 2009 Jun;32(5):344-51. doi: 10.1016/j.jmpt.2009.04.004.
- Institutional webpageLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing chiropractic treatment and Dr. Zaxx pillow in people with Cervicogenic Headache and Tension-type Headache, run by Canadian Memorial Chiropractic College at 1 site in Canada.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Howard Vernon, DC, PhD (416-482-2340 ext. 216, hvernon@cmcc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency from a Headache Diary (time frame: change from baseline in headache frequency at 5 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 NCT01509326, which also lists 1 linked publication.
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 13 Jan 2012.