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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

January 4, 2012
January 10, 2012
January 2012
October 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01509326 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Chiropractic and Acupressure for Headaches
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Cervicogenic Headache
  • Tension-type Headache
  • Migraine Headache
  • Other: chiropractic treatment
    12 sessions over 4 weeks
  • Device: Dr. Zaxx pillow
    Daily use of an acupressure pillow
  • Active Comparator: Chiropractic
    spinal manipulation, mobilization, massage, advice, exercises
    Intervention: Other: chiropractic treatment
  • Experimental: Chiropractic PLUS pillow
    spinal manipulation, mobilization, massage, advice, exercises, pillow
    Intervention: Device: Dr. Zaxx pillow
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. Erratum in: J Manipulative Physiol Ther. 2009 Nov-Dec;32(9):804.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
November 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Howard Vernon, DC, PhD 416-482-2340 ext 216 hvernon@cmcc.ca
Canada
 
NCT01509326
112049
No
Howard Vernon, Canadian Memorial Chiropractic College
Canadian Memorial Chiropractic College
Dr. Zaxx Co.
Not Provided
Canadian Memorial Chiropractic College
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP