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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Werner Becker, University of Calgary
ClinicalTrials.gov Identifier:
NCT01980927
First received: November 4, 2013
Last updated: December 10, 2014
Last verified: December 2014
  Purpose
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.

Condition Intervention
Migraine Procedure: NUCCA atlas correction

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Intracranial Compliance in Migraine Subjects Following a National Upper Cervical Chiropractic Association (NUCCA)Atlas Correction Intervention - a Pilot Study

Resource links provided by NLM:


Further study details as provided by Dr. Werner Becker, University of Calgary:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.

  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 11
Study Start Date: November 2011
Study Completion Date: November 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01980927

Locations
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Werner Becker, MD, FRCPC University of Calgary
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Werner Becker, Dr. Werner Becker, MD, FRCPC, University of Calgary
ClinicalTrials.gov Identifier: NCT01980927     History of Changes
Other Study ID Numbers: 24116
Study First Received: November 4, 2013
Last Updated: December 10, 2014

Keywords provided by Dr. Werner Becker, University of Calgary:
Migraine
National Upper Cervical Chiropractic Association atlas correction

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 21, 2017