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

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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:
Collaborator:
National Chiropractic Mutual Insurance Company (NCMIC)
Information provided by (Responsible Party):
Nick Moser, Canadian Memorial Chiropractic College

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Vertebral Artery Dissection
Cerebrovascular Accident
Stroke
Intervention Other: Head positions and spinal manipulation
Enrollment 20
Recruitment Details Twenty patients were recruited from the campus-teaching clinic located at the Canadian Memorial Chiropractic College. Included were adults aged 18 years and older with chronic grade II mechanical neck pain that had been prescribed cervical manipulation for treatment of their condition
Pre-assignment Details  
Arm/Group Title Intervention Group
Hide Arm/Group 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. 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.
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Intervention Group
Hide Arm/Group 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.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years 0
Between 18 and 65 years 19
>=65 years 1
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
32  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
14
  70.0%
Male
6
  30.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
15
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
5
  25.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group
Hide Arm/Group 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. 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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: cm/s
Neutral head position 15.5  (3.5)
Maximum head rotation 15.1  (3.9)
Cervical manipulation 14.7  (3.6)
2.Secondary Outcome
Title Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group
Hide Arm/Group Description:

Participants included in the experimental arm will be adults aged 18 years and older with chronic neck pain who have been prescribed cervical manipulation for treatment of their condition. Each participant will undergo three separate test maneuvers. 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.

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 fo

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ml/100g of tissue/minute
Neutral head position 79.2  (25)
Maximum head rotation 79  (25.5)
Cervical manipulation 80.1  (26.6)
3.Other Pre-specified Outcome
Title Changes in Blood Flow Through Vertebral Artery
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group
Hide Arm/Group 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. 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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: mL/s
Neutral neck position 1.8  (0.7)
Manipulation 1.8  (0.8)
Maximum rotation 1.7  (0.6)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group
Hide Arm/Group 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. 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.
All-Cause Mortality
Intervention Group
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group
Affected / at Risk (%) # Events
Total   1/20 (5.00%)    
Musculoskeletal and connective tissue disorders   
Minor aggravation of neck pain * [1]  1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One patient reported minor aggravation of local neck pain. Attributed to lying on MRI table for prolonged period. Pain no longer present at follow-up 24 hours later.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Nicholas Moser
Organization: Canadian Memorial Chiropractic College
Phone: 416-482-2340 ext 319
Publications:
Responsible Party: Nick Moser, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT02667821     History of Changes
Other Study ID Numbers: 162001
First Submitted: January 18, 2016
First Posted: January 29, 2016
Results First Submitted: July 19, 2017
Results First Posted: September 12, 2017
Last Update Posted: October 10, 2017