Chiropractic and Acupressure for Headaches

January 10, 2012 updated by: Howard Vernon, Canadian Memorial Chiropractic College

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M2H 3J1
        • Recruiting
        • Canadian Memorial Chiropractic College
        • Contact:
        • Principal Investigator:
          • Howard Vernon, DC, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache frequency from a Headache Diary
Time Frame: change from baseline in headache frequency at 5 weeks
Daily Headache Diary
change from baseline in headache frequency at 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache disability
Time Frame: baseline / end of treatment (5 weeks)
Headache Disability Index
baseline / end of treatment (5 weeks)
Treatment satisfaction
Time Frame: end of treatment (5 weeks)
Small scale for rating satisfaction with treatment
end of treatment (5 weeks)
Adverse events
Time Frame: up to five weeks
pain, stiffness, dizziness
up to five weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Memorial Chiropractic College

Collaborators

Dr. Zaxx Co.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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