Trial Outcomes & Findings for Vertebral Artery and Cerebral Hemodynamics After Various Head Positions & Manipulation in Patients With Neck Pain (NCT NCT02667821)

Last Updated: 2017-10-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome 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.

Results posted on

2017-10-10

Participant Flow

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

Participant milestones

Participant milestones
Measure	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. 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 Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=20 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	32 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment Canada	20 Participants n=5 Participants

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=20 Participants 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.
Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation Neutral head position	15.5 cm/s Standard Deviation 3.5
Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation Maximum head rotation	15.1 cm/s Standard Deviation 3.9
Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation Cervical manipulation	14.7 cm/s Standard Deviation 3.6

SECONDARY outcome

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.

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=20 Participants 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.
Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique. Maximum head rotation	79 ml/100g of tissue/minute Standard Deviation 25.5
Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique. Neutral head position	79.2 ml/100g of tissue/minute Standard Deviation 25
Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique. Cervical manipulation	80.1 ml/100g of tissue/minute Standard Deviation 26.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention Group n=20 Participants 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.
Changes in Blood Flow Through Vertebral Artery Neutral neck position	1.8 mL/s Standard Deviation 0.7
Changes in Blood Flow Through Vertebral Artery Manipulation	1.8 mL/s Standard Deviation 0.8
Changes in Blood Flow Through Vertebral Artery Maximum rotation	1.7 mL/s Standard Deviation 0.6

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention Group n=20 participants at risk 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.
Musculoskeletal and connective tissue disorders Minor aggravation of neck pain	5.0% 1/20 • Number of events 1 • 1 year

Additional Information

Dr. Nicholas Moser

Canadian Memorial Chiropractic College

Phone: 416-482-2340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place