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

NCT ID: NCT01205490

Last Updated: 2011-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Vertebral Artery Dissection Cerebrovascular Accident Cerebrovascular Stroke

Study Design

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Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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head positions and spinal manipulation

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

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

1. Enrolled and matriculated as a student in the Canadian Memorial Chiropractic College.
2. 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.
3. Sufficient English language ability to complete study questionnaires (see appendix).
4. No history of disabling neck, arm or headache pain within the last 6 months.
5. 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.
6. Subjects will have had no prior history of head trauma or prior history of surgery to the neck region.
7. No history of claustrophobia, metallic implants or tattoos to ensure compatibility with MRI requirements.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Medical Protective Association

OTHER

Sponsor Role collaborator

NCMIC

UNKNOWN

Sponsor Role collaborator

Canadian Memorial Chiropractic College

OTHER

Sponsor Role lead

Responsible Party

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University of Toronto

Principal Investigators

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Greg Wells, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Jairus Quesnele, BSc, DC

Role: PRINCIPAL_INVESTIGATOR

Canadian Memorial Chiropractic College

John J Triano, DC, PhD

Role: STUDY_CHAIR

Canadian Memorial Chiropractic College

Michael Noseworthy, PhD

Role: STUDY_DIRECTOR

McMaster University

Locations

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St. Joseph Healthcare, Research Imaging Institute

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Jairus J Quesnele, BSc, DC

Role: CONTACT

647 261 2760

Greg Wells, PhD

Role: CONTACT

416-710-4618

Facility Contacts

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Michael Noseworthy, PhD

Role: primary

Greg Wells, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 19251064 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19251066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15933263 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12890438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15800509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12902962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10688956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14504337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8864968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9467098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10519558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3512861 (View on PubMed)

Other Identifiers

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102026

Identifier Type: -

Identifier Source: org_study_id

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