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Chiropractic and Acupressure for Headaches

Primary Purpose

Cervicogenic Headache, Tension-type Headache, Migraine Headache

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
chiropractic treatment
Dr. Zaxx pillow
Sponsored by
Canadian Memorial Chiropractic College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring headache, chiropractic, manipulation, acupressure, self-care

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Canadian Memorial Chiropractic CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chiropractic

Chiropractic PLUS pillow

Arm Description

spinal manipulation, mobilization, massage, advice, exercises

spinal manipulation, mobilization, massage, advice, exercises, pillow

Outcomes

Primary Outcome Measures

Headache frequency from a Headache Diary
Daily Headache Diary

Secondary Outcome Measures

Headache disability
Headache Disability Index
Treatment satisfaction
Small scale for rating satisfaction with treatment
Adverse events
pain, stiffness, dizziness

Full Information

First Posted
January 4, 2012
Last Updated
January 10, 2012
Sponsor
Canadian Memorial Chiropractic College
Collaborators
Dr. Zaxx Co.
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1. Study Identification

Unique Protocol Identification Number
NCT01509326
Brief Title
Chiropractic and Acupressure for Headaches
Official Title
A Randomized Clinical Trial of Chiropractic Care for Headaches With and Without an Acupressure Device
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canadian Memorial Chiropractic College
Collaborators
Dr. Zaxx Co.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache, Tension-type Headache, Migraine Headache
Keywords
headache, chiropractic, manipulation, acupressure, self-care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chiropractic
Arm Type
Active Comparator
Arm Description
spinal manipulation, mobilization, massage, advice, exercises
Arm Title
Chiropractic PLUS pillow
Arm Type
Experimental
Arm Description
spinal manipulation, mobilization, massage, advice, exercises, pillow
Intervention Type
Other
Intervention Name(s)
chiropractic treatment
Intervention Description
12 sessions over 4 weeks
Intervention Type
Device
Intervention Name(s)
Dr. Zaxx pillow
Intervention Description
Daily use of an acupressure pillow
Primary Outcome Measure Information:
Title
Headache frequency from a Headache Diary
Description
Daily Headache Diary
Time Frame
change from baseline in headache frequency at 5 weeks
Secondary Outcome Measure Information:
Title
Headache disability
Description
Headache Disability Index
Time Frame
baseline / end of treatment (5 weeks)
Title
Treatment satisfaction
Description
Small scale for rating satisfaction with treatment
Time Frame
end of treatment (5 weeks)
Title
Adverse events
Description
pain, stiffness, dizziness
Time Frame
up to five weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Howard Vernon, DC, PhD
Phone
416-482-2340
Ext
216
Email
hvernon@cmcc.ca
Facility Information:
Facility Name
Canadian Memorial Chiropractic College
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2H 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Fillery, BA
Phone
416-482-2340
Ext
267
Email
mfillery@cmcc.ca
First Name & Middle Initial & Last Name & Degree
Howard Vernon, DC, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19539116
Citation
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.
Results Reference
background
Links:
URL
http://www.cmcc.ca
Description
Institutional webpage

Learn more about this trial

Chiropractic and Acupressure for Headaches

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