Back to results

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

Primary Purpose

Migraine

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

NUCCA atlas correction

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, National Upper Cervical Chiropractic Association atlas correction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Foothills Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NUCCA atlas correction

Arm Description

NUCCA atlas correction for migraine patients

Outcomes

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.

Secondary Outcome Measures

Days with headache per month

Patients use headache diaries to track the number of days with headaches.

Average headache intensity on headache days

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.

Full Information

NCT ID

NCT01980927

First Posted

November 4, 2013

Last Updated

December 10, 2014

Sponsor

University of Calgary

1. Study Identification

Unique Protocol Identification Number

NCT01980927

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Calgary

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

Keywords

Migraine, National Upper Cervical Chiropractic Association atlas correction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NUCCA atlas correction

Arm Type

Experimental

Arm Description

NUCCA atlas correction for migraine patients

Intervention Type

Procedure

Intervention Name(s)

NUCCA atlas correction

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

At baseline, at 4 weeks, at 8 weeks

Secondary Outcome Measure Information:

Title

Days with headache per month

Description

Patients use headache diaries to track the number of days with headaches.

Time Frame

At baseline, at 4 weeks, at 8 weeks

Title

Average headache intensity on headache days

Description

Time Frame

At baseline, at 4 weeks, at 8 weeks

Other Pre-specified Outcome Measures:

Title

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

Description

Using MIDAS, Migraine QOL, and HIT-6 questionnaires to score patients' quality of life in measurable terms.

Time Frame

At baseline, at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Werner Becker, MD, FRCPC

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Foothills Hospital

City

Calgary

State/Province

Alberta

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

26783523

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs