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Changes in Cerebral Blood Flow With Spinal Manipulative Therapy vs. Voluntary Motion

Primary Purpose

Vertebral Artery Dissection, Cerebrovascular Accident, Cerebrovascular Stroke

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

head positions and spinal manipulation

About this trial

This is an interventional basic science trial for Vertebral Artery Dissection

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion/Exclusion Criteria

Enrolled and matriculated as a student in the Canadian Memorial Chiropractic College.
Healthy asymptomatic male patients who would otherwise receive cervical manipulation on a regular basis as a part of their normal learning experience and will have had a cervical manipulation in the last 3 months.
Sufficient English language ability to complete study questionnaires (see appendix).
No history of disabling neck, arm or headache pain within the last 6 months.
No current or prior history of neurological symptoms including, facial or extremity weakness, abnormal sensation to the face, body or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing.
Subjects will have had no prior history of head trauma or prior history of surgery to the neck region.
No history of claustrophobia, metallic implants or tattoos to ensure compatibility with MRI requirements.

Sites / Locations

St. Joseph Healthcare, Research Imaging Institute

Outcomes

Primary Outcome Measures

change in advanced magnetic resonance imaging

A change in vertebral, posterior cerebellar and collateral arterial blood flow associated with various head positions and an upper cervical manipulation will be measured using blood oxygen level dependent (BOLD). A BOLD MRI generates a signal by tracking changes in the local oxyhemoglobin to deoxyhemoglobin ratio. Signal changes are due to a combination of altered microvascular perfusion, blood volume, and fluctuations in cellular metabolism. It will also provide more sensitivity in determining the impact of changes in blood flow during the various head positions.

Secondary Outcome Measures

Full Information

NCT ID

NCT01205490

First Posted

September 17, 2010

Last Updated

June 27, 2011

Sponsor

Canadian Memorial Chiropractic College

Collaborators

Canadian Medical Protective Association, NCMIC

1. Study Identification

Unique Protocol Identification Number

NCT01205490

Brief Title

Changes in Cerebral Blood Flow With Spinal Manipulative Therapy vs. Voluntary Motion

Official Title

Changes in Cerebral Blood Flow With Spinal Manipulative Therapy vs. Voluntary Motion

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2011 (undefined)

Primary Completion Date

August 2012 (Anticipated)

Study Completion Date

August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Canadian Memorial Chiropractic College

Collaborators

Canadian Medical Protective Association, NCMIC

4. Oversight

5. Study Description

Brief Summary

The investigators are performing a study to determine whether changes in blood flow occur in the neck and back of the brain following a series of head positions and a manipulation of the upper neck. Each participant will be asked to undergo a series of MRI's to evaluate whether there are any changes in blood flow resulting from any of the head positions or manipulation. The study will be conducted over a period of 1 day and each participant can anticipate the testing to take approximately 120 minutes.

Detailed Description

The goal is to further investigate the cerebrovascular hemodynamic consequences of cervical spine positions, including rotation and manipulation in-vivo under clinically relevant circumstances using two advanced forms of MRI technology on the VA and posterior cerebral vessels. According to the knowledge of the investigators, a study utilizing MRI and functional blood oxygen level dependent (fBOLD) imaging to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these vessels has yet to be conducted.

6. Conditions and Keywords

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

Vertebral Artery Dissection, Cerebrovascular Accident, Cerebrovascular Stroke

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Masking

Outcomes Assessor

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

head positions and spinal manipulation

Intervention Description

Each subject will then undergo a baseline MRI in a head neutral position (0 degrees rotation). They will then be placed in head rotation (45 degrees) to the non-dominant and undergo a MRI. Maximum rotation to the side with MRI will follow. Finally, each subject will receive an upper cervical rotary manipulation to the non-dominant side with MRI immediately after. A total of 4 test conditions will be evaluated (rest, 45 degree, maximal, post-manipulation). The manipulation will be performed by an experience practitioner on a bed just outside the MRI room in supine position. A controlled impulse load will be applied and the head/neck returned to neutral position. Prior to each maneuver, the subject will be queried on their comfort, condition and willingness to continue

Primary Outcome Measure Information:

Title

change in advanced magnetic resonance imaging

Description

Time Frame

immediately after head positions.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion/Exclusion Criteria Enrolled and matriculated as a student in the Canadian Memorial Chiropractic College. Healthy asymptomatic male patients who would otherwise receive cervical manipulation on a regular basis as a part of their normal learning experience and will have had a cervical manipulation in the last 3 months. Sufficient English language ability to complete study questionnaires (see appendix). No history of disabling neck, arm or headache pain within the last 6 months. No current or prior history of neurological symptoms including, facial or extremity weakness, abnormal sensation to the face, body or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing. Subjects will have had no prior history of head trauma or prior history of surgery to the neck region. No history of claustrophobia, metallic implants or tattoos to ensure compatibility with MRI requirements.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jairus J Quesnele, BSc, DC

Phone

647 261 2760

jquesnele@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Greg Wells, PhD

Phone

416-710-4618

greg.wells@utoronto.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Greg Wells, PhD

Organizational Affiliation

University of Toronto

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jairus Quesnele, BSc, DC

Organizational Affiliation

Canadian Memorial Chiropractic College

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John J Triano, DC, PhD

Organizational Affiliation

Canadian Memorial Chiropractic College

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Michael Noseworthy, PhD

Organizational Affiliation

McMaster University

Official's Role

Study Director

Facility Information:

Facility Name

St. Joseph Healthcare, Research Imaging Institute

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Noseworthy, PhD

nosewor@mcmaster.ca

First Name & Middle Initial & Last Name & Degree

Greg Wells, PhD

greg.wells@utoronto.ca

First Name & Middle Initial & Last Name & Degree

Greg Wells, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19251064

Citation

Boyle E, Cote P, Grier AR, Cassidy JD. Examining vertebrobasilar artery stroke in two Canadian provinces. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S194-200. doi: 10.1016/j.jmpt.2008.11.019.

Results Reference

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PubMed Identifier

19251066

Citation

Cassidy JD, Boyle E, Cote P, He Y, Hogg-Johnson S, Silver FL, Bondy SJ. Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case-control and case-crossover study. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S201-8. doi: 10.1016/j.jmpt.2008.11.020.

Results Reference

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PubMed Identifier

15933263

Citation

Rubinstein SM, Peerdeman SM, van Tulder MW, Riphagen I, Haldeman S. A systematic review of the risk factors for cervical artery dissection. Stroke. 2005 Jul;36(7):1575-80. doi: 10.1161/01.STR.0000169919.73219.30. Epub 2005 Jun 2.

Results Reference

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PubMed Identifier

12890438

Citation

Zaina C, Grant R, Johnson C, Dansie B, Taylor J, Spyropolous P. The effect of cervical rotation on blood flow in the contralateral vertebral artery. Man Ther. 2003 May;8(2):103-9. doi: 10.1016/s1356-689x(02)00155-8.

Results Reference

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PubMed Identifier

15800509

Citation

Cagnie B, Jacobs F, Barbaix E, Vinck E, Dierckx R, Cambier D. Changes in cerebellar blood flow after manipulation of the cervical spine using Technetium 99m-ethyl cysteinate dimer. J Manipulative Physiol Ther. 2005 Feb;28(2):103-7. doi: 10.1016/j.jmpt.2005.01.005.

Results Reference

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PubMed Identifier

12902962

Citation

Mitchell JA. Changes in vertebral artery blood flow following normal rotation of the cervical spine. J Manipulative Physiol Ther. 2003 Jul-Aug;26(6):347-51. doi: 10.1016/S0161-4754(03)00074-5.

Results Reference

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PubMed Identifier

10688956

Citation

Johnson C, Grant R, Dansie B, Taylor J, Spyropolous P. Measurement of blood flow in the vertebral artery using colour duplex Doppler ultrasound: establishment of the reliability of selected parameters. Man Ther. 2000 Feb;5(1):21-9. doi: 10.1054/math.1999.0227.

Results Reference

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PubMed Identifier

14504337

Citation

Sakaguchi M, Kitagawa K, Hougaku H, Hashimoto H, Nagai Y, Yamagami H, Ohtsuki T, Oku N, Hashikawa K, Matsushita K, Matsumoto M, Hori M. Mechanical compression of the extracranial vertebral artery during neck rotation. Neurology. 2003 Sep 23;61(6):845-7. doi: 10.1212/01.wnl.0000078081.12097.ae.

Results Reference

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PubMed Identifier

8864968

Citation

Haynes MJ. Doppler studies comparing the effects of cervical rotation and lateral flexion on vertebral artery blood flow. J Manipulative Physiol Ther. 1996 Jul-Aug;19(6):378-84.

Results Reference

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PubMed Identifier

9467098

Citation

Licht PB, Christensen HW, Hojgaard P, Hoilund-Carlsen PF. Triplex ultrasound of vertebral artery flow during cervical rotation. J Manipulative Physiol Ther. 1998 Jan;21(1):27-31.

Results Reference

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PubMed Identifier

10519558

Citation

Licht PB, Christensen HW, Svendensen P, Hoilund-Carlsen PF. Vertebral artery flow and cervical manipulation: an experimental study. J Manipulative Physiol Ther. 1999 Sep;22(7):431-5. doi: 10.1016/s0161-4754(99)70030-8.

Results Reference

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PubMed Identifier

3512861

Citation

Bendick PJ, Jackson VP. Evaluation of the vertebral arteries with duplex sonography. J Vasc Surg. 1986 Mar;3(3):523-30. doi: 10.1067/mva.1986.avs0030523.

Results Reference

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Changes in Cerebral Blood Flow With Spinal Manipulative Therapy vs. Voluntary Motion

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