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NCT01509326 Clinical Trial

Chiropractic and Acupressure for Headaches

Migraine Headache Clinical Trial

Official title:
A Randomized Clinical Trial of Chiropractic Care for Headaches With and Without an Acupressure Device

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01509326
Other study ID # 112049
Secondary ID
Status Unknown status
Phase Phase 2/Phase 3
First received January 4, 2012
Last updated January 10, 2012
Start date January 2012
Est. completion date November 2012

Study information
Verified date January 2012
Source Canadian Memorial Chiropractic College
Contact Howard Vernon, DC, PhD
Phone 416-482-2340
Email hvernon@cmcc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 36
Est. completion date November 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- males and females

- ages 21-60

- recurrent headaches

- sub-occipital tenderness

- a minimum of 4 headaches per month

Exclusion Criteria:

- migraine with aura

- sinus headache

- any other organic pathology

- any contraindications to cervical manipulation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• chiropractic treatment
12 sessions over 4 weeks
Device:
• Dr. Zaxx pillow
Daily use of an acupressure pillow

Locations
Country Name City State
Canada Canadian Memorial Chiropractic College Toronto Ontario

Sponsors (2)
Lead Sponsor Collaborator
Canadian Memorial Chiropractic College Dr. Zaxx Co.

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. Erratum in: J Manipulative Physiol Ther. 2009 Nov-Dec;32(9):804. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Headache frequency from a Headache Diary Daily Headache Diary change from baseline in headache frequency at 5 weeks
Secondary Headache disability Headache Disability Index baseline / end of treatment (5 weeks)
Secondary Treatment satisfaction Small scale for rating satisfaction with treatment end of treatment (5 weeks)
Secondary Adverse events pain, stiffness, dizziness up to five weeks
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