Vertebral Artery and Cerebral Hemodynamics After Various Head Positions & Manipulation in Patients With Neck Pain

• ClinicalTrials.gov Identifier: NCT02667821
• Recruitment Status: Completed
• First Posted: January 29, 2016
• Results First Posted: September 12, 2017
• Last Update Posted: October 10, 2017
• Sponsor: Canadian Memorial Chiropractic College
• Collaborator: National Chiropractic Mutual Insurance Company (NCMIC)
• Information provided by (Responsible Party): Nick Moser, Canadian Memorial Chiropractic College

Study Description

Brief Summary:

The Investigators are performing a study to determine, in patients with chronic/recurrent neck pain, the cerebrovascular hemodynamic consequences of cervical spine movements, including manipulation, in vivo using fMRI technology on vertebral and cranial blood flow dynamics affecting brain perfusion, and extend the current data set on these variables

Condition or disease	Intervention/treatment	Phase
Vertebral Artery Dissection; Cerebrovascular Accident; Stroke	Other: Head positions and spinal manipulation	Not Applicable

Detailed Description:

The goal of the study is to further investigate in patients with chronic/recurrent neck pain, the cerebrovascular hemodynamic consequences of cervical spine positions, including manipulation, in vivo under clinically relevant circumstances using two advanced MRI technology on the vertebral and posterior cerebral and cerebellar blood flow dynamics affecting brain perfusion. According to the knowledge of the investigators, a study utilizing MRI to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these blood vessels has yet to be conducted.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Changes in Vertebral Artery and Cerebral Hemodynamics Following Various Head Positions & Cervical Manipulation in Patients With Chronic/Recurrent Neck Pain
• Actual Study Start Date: June 2016
• Actual Primary Completion Date: May 2017
• Actual Study Completion Date: May 2017

Arms and Interventions

Arm

Intervention/treatment

Experimental: Intervention group; Participants included in the experimental arm will be adults aged 18 years and older with chronic/recurrent neck pain Grade II who have been prescribed cervical manipulation for treatment of their condition. Each participant will undergo three separate test maneuvers consistent with prior work completed at the St. Joseph's Healthcare Hamilton Brain Body Institute. Each participant will begin with neutral cervical spine as a standard natural control, followed by block randomization between maximum voluntary rotation of the cervical spine and one cervical manipulation. Please see Intervention section for a detailed description.

Other: Head positions and spinal manipulation; Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.

Outcome Measures

Primary Outcome Measures :

1. Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation [ Time Frame: The series of fMRI sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year. ]
   Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood velocity (cm/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05

Secondary Outcome Measures :

1. Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique. [ Time Frame: The series of ASL sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year. ]
   ASL allows one to separate the blood flow from the BOLD effect, thus giving clear measures of perfusion. More specifically ASL will be used to measure blood perfusion and allow extraction of metabolic difference from flow differences in BOLD imaging. It is a quantitative technique, yielding values with units of ml/(100g of tissue)·min-1.

Other Outcome Measures:

1. Changes in Blood Flow Through Vertebral Artery [ Time Frame: The series of fMRI sequences will be performed on each participant immediately after each procedure. ]
   Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood flow (mL/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Adults aged 18 years and older with chronic/recurrent neck pain Grade II.
2. Must have been prescribed cervical spinal manipulation for treatment of their neck pain condition.

Exclusion Criteria:

1. A history of neck pain with associated arm pain within the last 6 months
2. Any current or history of neurologic 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
3. History of new or severe (Visual Analogue Scale >6) headaches in the last 3 months
4. Any contraindications to MRI
5. Any history of using drugs that affect blood flow such as Warfarin, or anti-coagulants.

Contacts and Locations

Locations

Canada, Ontario

St. Joseph Healthcare, Research Imaging Institute

Hamilton, Ontario, Canada, L8N 4A6

Sponsors and Collaborators

Canadian Memorial Chiropractic College

National Chiropractic Mutual Insurance Company (NCMIC)

Investigators

• Principal Investigator: Greg Wells, PhD; University of Toronto
• Principal Investigator: Nicholas Moser, BSc, Dc; Canadian Memorial Chiropractic College
• Study Chair: John J Triano, DC, PhD; Canadian Memorial Chiropractic College
• Study Director: Michael Noseworthy, PhD; McMaster University
• Principal Investigator: Silvano Mior, DC, PhD; Canadian Memorial Chiropractic College

  Study Documents (Full-Text)

Documents provided by Nick Moser, Canadian Memorial Chiropractic College:

Study Protocol and Statistical Analysis Plan  [PDF] August 14, 2017

Informed Consent Form  [PDF] February 27, 2017

More Information

Publications:

Boyle E, Côté 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.

Cassidy JD, Boyle E, Côté 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.

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. Epub 2005 Jun 2. Review.

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.

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.

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.

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.

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.

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.

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

Licht PB, Christensen HW, Svendensen P, Høilund-Carlsen PF. Vertebral artery flow and cervical manipulation: an experimental study. J Manipulative Physiol Ther. 1999 Sep;22(7):431-5.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moser N, Mior S, Noseworthy M, Côté P, Wells G, Behr M, Triano J. Effect of cervical manipulation on vertebral artery and cerebral haemodynamics in patients with chronic neck pain: a crossover randomised controlled trial. BMJ Open. 2019 May 28;9(5):e025219. doi: 10.1136/bmjopen-2018-025219.

• Responsible Party: Nick Moser, Local contact investigator, Canadian Memorial Chiropractic College
• ClinicalTrials.gov Identifier: NCT02667821
• Other Study ID Numbers: 162001
• First Posted: January 29, 2016
• Results First Posted: September 12, 2017
• Last Update Posted: October 10, 2017
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Study results will be made public through peer-reviewed journal publications, presentations, clinical trial registration and report to participants. If participants are interested in information on the outcome of the study they may request a report from their own data and / or aggregated data either at the time of consent and data capture by signing an area on the informed consent document or subsequently by written request to the principal investigator. ROF will be submitted to indexed and peer-reviewed journals interested in imaging and clinical biomechanics of the spine.

Additional relevant MeSH terms:

Stroke; Vertebral Artery Dissection; Aneurysm, Dissecting; Neck Pain; Pain; Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Aneurysm; Cerebrovascular Trauma; Trauma, Nervous System; Wounds and Injuries