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

NCT02667821 | Completed Results

• 1 other identifier: 162001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Vertebral Artery Dissection; Cerebrovascular Accident; Stroke

Outcome Measures

Primary Outcomes (1)

• 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

  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 (1)

• Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique.

  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 (1)

• Changes in Blood Flow Through Vertebral Artery

  The series of fMRI sequences will be performed on each participant immediately after each procedure.

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

Head positions and spinal manipulation OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Memorial Chiropractic College: lead
• National Chiropractic Mutual Insurance Company (NCMIC): collaborator

Study Sites (1)

St. Joseph Healthcare, Research Imaging Institute

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (13)

• 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.

  PMID: 19251064 BACKGROUND

• 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.

  PMID: 19251066 BACKGROUND

• 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.

  PMID: 15933263 BACKGROUND

• 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.

  PMID: 12890438 BACKGROUND

• 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.

  PMID: 15800509 BACKGROUND

• 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.

  PMID: 12902962 BACKGROUND

• 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.

  PMID: 10688956 BACKGROUND

• 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.

  PMID: 14504337 BACKGROUND

• 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.

  PMID: 8864968 BACKGROUND

• 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.

  PMID: 9467098 BACKGROUND

• 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.

  PMID: 10519558 BACKGROUND

• 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.

  PMID: 3512861 BACKGROUND

• 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.

  PMID: 31142519 DERIVED

MeSH Terms

Conditions

Vertebral Artery Dissection; Stroke

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Cerebrovascular Trauma; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Results Point of Contact

• Title: Dr. Nicholas Moser
• Organization: Canadian Memorial Chiropractic College

nmoser@cmcc.ca

416-482-2340

Study Officials

• Greg Wells, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Nicholas Moser, BSc, Dc

  Canadian Memorial Chiropractic College

  PRINCIPAL INVESTIGATOR

• John J Triano, DC, PhD

  Canadian Memorial Chiropractic College

  STUDY CHAIR

• Michael Noseworthy, PhD

  McMaster University

  STUDY DIRECTOR

• Silvano Mior, DC, PhD

  Canadian Memorial Chiropractic College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Local contact investigator

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 29, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 10, 2017
• Results First Posted: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)