Changes in Intracranial Compliance in Migraine Subjects Following a National Upper Cervical Chiropractic Association Atlas Correction

December 10, 2014 updated by: Dr. Werner Becker, University of Calgary

Changes in Intracranial Compliance in Migraine Subjects Following a National Upper Cervical Chiropractic Association (NUCCA)Atlas Correction Intervention - a Pilot Study

A small number of chiropractors, who align only the atlas C-1, or "top" vertebra in the spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas correction procedure. This procedure uses a precise, non-invasive, gentle touch technique to correct misalignment of the atlas. Although NUCCA practitioners have long used this procedure in the treatment of headache, it has not been formally studied using clinical trials. There is some data indicating that NUCCA correction can increase intracranial compliance. This intracranial compliance can be measured by a magnetic resonance imaging (MRI) study before and then after a NUCCA procedure. In this study, the investigators hope to show that the correction of an atlas misalignment will increase intracranial compliance in subjects with migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

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
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be 18-65 years of age.
  • Be naive to Upper Cervical Chiropractic care. Other forms of chiropractic care in the past are permitted.
  • Have migraine with or without aura.
  • Have between 10-26 headache days per month over the last 4 months.
  • Have at least 4 separate headache episodes per month, with episodes separated by at least 4 hours of painfree time.
  • Have at least 8 days per month with pain of levels greater than or equal to 4/10 for part of the day, or have attacks successfully treated with migraine specific medication.
  • Be candidates suitable for NUCCA therapeutic intervention because of atlas displacement as assessed by NUCCA investigator.
  • Subjects on acceptable pharmacological prophylaxis must either remain on a stable dose throughout the study, or stop the prophylactic medication one month before entering the baseline period.

Exclusion Criteria:

  • Any medical or psychiatric condition which in the opinion of the investigator would make the subject unsuitable for enrolment, because of inability to comply with study requirements or possible confounding of the results.
  • Headache on more than 26 days per month.
  • Acute medication overuse as defined by the International Classification of Headache Disorders.
  • Pregnancy or lactation
  • Severe cervical spine degeneration as assessed by cervical spine x-ray.
  • Claustrophobia or any condition that contraindicates an MRI scan
  • A history of cardiovascular disease, cerebrovascular disease, brain surgery, or other central nervous system disorder.
  • Other chronic pain disorder which might interfere with headache assessment or study procedures.
  • A history of significant hypo- or hypertension as determined by the investigator.
  • Subject on a beta-blocker, calcium channel blocker, or other medication which the investigator considers might alter cerebral vascular regulation. Triptans are allowed, but must not be taken within 24 hours (48 hours for frovatriptan) before an MRI study.
  • A history of substance abuse or dependence within 1 year.
  • Current participation in a research study or within the last 30 days.
  • Any spinal chiropractic care outside of the study protocol is prohibited during the baseline and treatment period.
  • Use of botulinum A within 4 months of study entry.
  • A history of significant head or neck trauma (as judged by the investigator) within the year prior to study entry.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NUCCA atlas correction
NUCCA atlas correction for migraine patients
Procedure: NUCCA atlas correction
A chiropractic procedure involving correcting a misalignment of the atlas or "top" vertebra in the spine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in intracranial compliance; comparing the baseline period to one month post treatment, 4 weeks after initiation of NUCCA care and maintained correction of atlas misalignment, as measured by phase contrast magnetic resonance imaging.
Time Frame: At baseline, at 4 weeks, at 8 weeks
At baseline, at 4 weeks, at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days with headache per month
Time Frame: At baseline, at 4 weeks, at 8 weeks
Patients use headache diaries to track the number of days with headaches.
At baseline, at 4 weeks, at 8 weeks
Average headache intensity on headache days
Time Frame: At baseline, at 4 weeks, at 8 weeks
Patients rate headache pain from 0-10 on 3 segments of the day (morning, afternoon, evening) using headache diaries. These numbers are used to calculate the average intensity of the headache on headache days.
At baseline, at 4 weeks, at 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life measurements - comparing quality of life scores by using various questionnaires at baseline and at 8 weeks
Time Frame: At baseline, at 8 weeks
Using MIDAS, Migraine QOL, and HIT-6 questionnaires to score patients' quality of life in measurable terms.
At baseline, at 8 weeks

Collaborators and Investigators

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

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Werner Becker, MD, FRCPC, University of Calgary

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

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

November 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 12, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24116

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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