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OpenTrials
Completed

NCT Number: NCT01980927

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Hospital

Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NUCCA atlas correction

Procedure

A chiropractic procedure involving correcting a misalignment of the atlas or "top" vertebra in the spine.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 11, 2013
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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