Cerebrovascular Accident, Stroke, Vertebral Artery Dissection
Conditions
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.
Interventions
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.
Sponsors
National Chiropractic Mutual Insurance Company (NCMIC)
Canadian Memorial Chiropractic College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood Flow Through Vertebral Artery | 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 |
Countries
Canada
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Intervention Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 32 years STANDARD_DEVIATION 12.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment Canada | 20 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | 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 |
| Intervention Group | 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 |
| Intervention Group | 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
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.
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | 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 |
| Intervention Group | 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 |
| Intervention Group | 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
Changes in Blood Flow Through Vertebral Artery
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Changes in Blood Flow Through Vertebral Artery | Neutral neck position | 1.8 mL/s | Standard Deviation 0.7 |
| Intervention Group | Changes in Blood Flow Through Vertebral Artery | Manipulation | 1.8 mL/s | Standard Deviation 0.8 |
| Intervention Group | Changes in Blood Flow Through Vertebral Artery | Maximum rotation | 1.7 mL/s | Standard Deviation 0.6 |