Back to resultsVertebral Artery and Cerebral Hemodynamics After Various Head Positions & Manipulation in Patients With Neck Pain
Primary Purpose
Vertebral Artery Dissection, Cerebrovascular Accident, Stroke
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Head positions and spinal manipulation
Sponsored by
About this trial
This is an interventional basic science trial for Vertebral Artery Dissection
Eligibility Criteria
Inclusion Criteria:
- Adults aged 18 years and older with chronic/recurrent neck pain Grade II.
- Must have been prescribed cervical spinal manipulation for treatment of their neck pain condition.
Exclusion Criteria:
- A history of neck pain with associated arm pain within the last 6 months
- 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
- History of new or severe (Visual Analogue Scale >6) headaches in the last 3 months
- Any contraindications to MRI
- Any history of using drugs that affect blood flow such as Warfarin, or anti-coagulants.
Sites / Locations
- St. Joseph Healthcare, Research Imaging Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
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.
Outcomes
Primary Outcome Measures
Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation
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
Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique.
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.
Full Information
NCT ID
NCT02667821
First Posted
January 18, 2016
Last Updated
September 11, 2017
Sponsor
Canadian Memorial Chiropractic College
Collaborators
National Chiropractic Mutual Insurance Company (NCMIC)
1. Study Identification
Unique Protocol Identification Number
NCT02667821
Brief Title
Vertebral Artery and Cerebral Hemodynamics After Various Head Positions & Manipulation in Patients With Neck Pain
Official Title
Changes in Vertebral Artery and Cerebral Hemodynamics Following Various Head Positions & Cervical Manipulation in Patients With Chronic/Recurrent Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canadian Memorial Chiropractic College
Collaborators
National Chiropractic Mutual Insurance Company (NCMIC)
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Artery Dissection, Cerebrovascular Accident, Stroke
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Head positions and spinal manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation
Description
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
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.
Secondary Outcome Measure Information:
Title
Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique.
Description
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.
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.
Other Pre-specified Outcome Measures:
Title
Changes in Blood Flow Through Vertebral Artery
Description
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
Time Frame
The series of fMRI sequences will be performed on each participant immediately after each procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults aged 18 years and older with chronic/recurrent neck pain Grade II.
Must have been prescribed cervical spinal manipulation for treatment of their neck pain condition.
Exclusion Criteria:
A history of neck pain with associated arm pain within the last 6 months
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
History of new or severe (Visual Analogue Scale >6) headaches in the last 3 months
Any contraindications to MRI
Any history of using drugs that affect blood flow such as Warfarin, or anti-coagulants.
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
Nicholas Moser, 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
First Name & Middle Initial & Last Name & Degree
Silvano Mior, DC, PhD
Organizational Affiliation
Canadian Memorial Chiropractic College
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph Healthcare, Research Imaging Institute
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
19251064
Citation
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Results Reference
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Citation
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Vertebral Artery and Cerebral Hemodynamics After Various Head Positions & Manipulation in Patients With Neck Pain
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