Clinical trial NCT02667821: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vertebral Artery Dissection
Cerebrovascular Accident
Stroke
Lead sponsor: Canadian Memorial Chiropractic College
Sponsor class: OTHER
Collaborators: name: National Chiropractic Mutual Insurance Company (NCMIC)
First posted: 2016-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation
timeFrame: 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 outcomes:
measure: Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique.
timeFrame: 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 outcomes:
measure: Changes in Blood Flow Through Vertebral Artery
timeFrame: The series of fMRI sequences will be performed on each participant immediately after each procedure.
Locations:
city: Hamilton
country: Canada
facility: St. Joseph Healthcare, Research Imaging Institute
state: Ontario
Study officials:
affiliation: University of Toronto
name: Greg Wells, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Memorial Chiropractic College
name: Nicholas Moser, BSc, Dc
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Memorial Chiropractic College
name: John J Triano, DC, PhD
role: STUDY_CHAIR
affiliation: McMaster University
name: Michael Noseworthy, PhD
role: STUDY_DIRECTOR
affiliation: Canadian Memorial Chiropractic College
name: Silvano Mior, DC, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Moser N, Mior S, Noseworthy M, Cote 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.