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Chiropractic and Acupressure for Headaches

This study is currently recruiting participants.
Verified January 2012 by Canadian Memorial Chiropractic College
Sponsor:
Collaborator:
Dr. Zaxx Co.
Information provided by (Responsible Party):
Howard Vernon, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier:
NCT01509326
First received: January 4, 2012
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Chiropractic Care for Headaches With and Without an Acupressure Device

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Canadian Memorial Chiropractic College:

Primary Outcome Measures:
  • Headache frequency from a Headache Diary [ Time Frame: change from baseline in headache frequency at 5 weeks ] [ Designated as safety issue: No ]
    Daily Headache Diary


Secondary Outcome Measures:
  • Headache disability [ Time Frame: baseline / end of treatment (5 weeks) ] [ Designated as safety issue: No ]
    Headache Disability Index

  • Treatment satisfaction [ Time Frame: end of treatment (5 weeks) ] [ Designated as safety issue: No ]
    Small scale for rating satisfaction with treatment

  • Adverse events [ Time Frame: up to five weeks ] [ Designated as safety issue: Yes ]
    pain, stiffness, dizziness


Estimated Enrollment: 36
Study Start Date: January 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Additional Information:
Institutional webpage  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Howard Vernon, Professor, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT01509326     History of Changes
Other Study ID Numbers: 112049
Study First Received: January 4, 2012
Last Updated: January 10, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013