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

NCT01980927 | Completed

• 1 other identifier: 24116
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Keywords

Migraine; National Upper Cervical Chiropractic Association atlas correction

Outcome Measures

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.

  At baseline, at 4 weeks, at 8 weeks

Secondary Outcomes (2)

• Days with headache per month

  At baseline, at 4 weeks, at 8 weeks

• Average headache intensity on headache days

  At baseline, at 4 weeks, at 8 weeks

Other Outcomes (1)

• Quality of life measurements - comparing quality of life scores by using various questionnaires at baseline and at 8 weeks

  At baseline, at 8 weeks

Study Arms (1)

NUCCA atlas correction

EXPERIMENTAL

NUCCA atlas correction for migraine patients

Procedure: NUCCA atlas correction

Interventions

NUCCA atlas correction PROCEDURE

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

NUCCA atlas correction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Hospital

Calgary, Alberta, Canada

Location

Related Publications (1)

• Woodfield HC 3rd, Hasick DG, Becker WJ, Rose MS, Scott JN. Effect of Atlas Vertebrae Realignment in Subjects with Migraine: An Observational Pilot Study. Biomed Res Int. 2015;2015:630472. doi: 10.1155/2015/630472. Epub 2015 Dec 10.

  PMID: 26783523 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Werner Becker, MD, FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Werner Becker, MD, FRCPC

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: November 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

CA (1)