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Chiropractic and Acupressure for Headaches

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ClinicalTrials.gov Identifier: NCT01509326
Recruitment Status : Unknown
Verified January 2012 by Howard Vernon, Canadian Memorial Chiropractic College.
Recruitment status was:  Recruiting
First Posted : January 13, 2012
Last Update Posted : January 13, 2012
Sponsor:
Collaborator:
Dr. Zaxx Co.
Information provided by (Responsible Party):
Howard Vernon, Canadian Memorial Chiropractic College

Brief 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.

Condition or disease Intervention/treatment Phase
Cervicogenic Headache Tension-type Headache Migraine Headache Other: chiropractic treatment Device: Dr. Zaxx pillow Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Chiropractic Care for Headaches With and Without an Acupressure Device
Study Start Date : January 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Chiropractic
spinal manipulation, mobilization, massage, advice, exercises
Other: chiropractic treatment
12 sessions over 4 weeks
Experimental: Chiropractic PLUS pillow
spinal manipulation, mobilization, massage, advice, exercises, pillow
Device: Dr. Zaxx pillow
Daily use of an acupressure pillow



Primary Outcome Measures :
  1. Headache frequency from a Headache Diary [ Time Frame: change from baseline in headache frequency at 5 weeks ]
    Daily Headache Diary


Secondary Outcome Measures :
  1. Headache disability [ Time Frame: baseline / end of treatment (5 weeks) ]
    Headache Disability Index

  2. Treatment satisfaction [ Time Frame: end of treatment (5 weeks) ]
    Small scale for rating satisfaction with treatment

  3. Adverse events [ Time Frame: up to five weeks ]
    pain, stiffness, dizziness



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509326


Contacts
Contact: Howard Vernon, DC, PhD 416-482-2340 ext 216 hvernon@cmcc.ca

Locations
Canada, Ontario
Canadian Memorial Chiropractic College Recruiting
Toronto, Ontario, Canada, M2H 3J1
Contact: Mark Fillery, BA    416-482-2340 ext 267    mfillery@cmcc.ca   
Principal Investigator: Howard Vernon, DC, PhD         
Sponsors and Collaborators
Canadian Memorial Chiropractic College
Dr. Zaxx Co.

Additional Information:
Publications:
Responsible Party: Howard Vernon, Professor, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT01509326     History of Changes
Other Study ID Numbers: 112049
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012

Keywords provided by Howard Vernon, Canadian Memorial Chiropractic College:
headache
chiropractic
manipulation
acupressure
self-care

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Post-Traumatic Headache
Headache Disorders, Primary
Headache Disorders
Headache Disorders, Secondary
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases