An interventional study of Head positions and spinal manipulation in Vertebral Artery Dissection, Cerebrovascular Accident and Stroke, sponsored by Canadian Memorial Chiropractic College. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-10.
Sponsored by Canadian Memorial Chiropractic College · Not applicable, Interventional, and Basic science
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
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Canadian Memorial Chiropractic College is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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.
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
| Milestone | Intervention Group |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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
| cm/s | Intervention Group |
|---|---|
| Neutral head position | 15.5 ± 3.5 |
| Maximum head rotation | 15.1 ± 3.9 |
| Cervical manipulation | 14.7 ± 3.6 |
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.
| ml/100g of tissue/minute | Intervention Group |
|---|---|
| Neutral head position | 79.2 ± 25 |
| Maximum head rotation | 79 ± 25.5 |
| Cervical manipulation | 80.1 ± 26.6 |
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
| mL/s | Intervention Group |
|---|---|
| Neutral neck position | 1.8 ± 0.7 |
| Manipulation | 1.8 ± 0.8 |
| Maximum rotation | 1.7 ± 0.6 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/20 (0%) | 0/20 (0%) | 1/20 (5%) |
| Event | Intervention Group |
|---|---|
| Minor aggravation of neck painMusculoskeletal and connective tissue disorders | 1/20 |
| Age, Categorical(Participants) | Intervention Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 1 |
| Age, Continuous(years) | Intervention Group |
|---|---|
| Mean | 32 ± 12.4 |
| Sex: Female, Male(Participants) | Intervention Group |
|---|---|
| Female | 14 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Intervention Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(Participants) | Intervention Group |
|---|---|
| Canada | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Study results will be made public through peer-reviewed journal publications, presentations, clinical trial registration and report to participants. If participants are interested in information on the outcome of the study they may request a report from their own data and / or aggregated data either at the time of consent and data capture by signing an area on the informed consent document or subsequently by written request to the principal investigator. ROF will be submitted to indexed and peer-reviewed journals interested in imaging and clinical biomechanics of the spine.
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Canadian Memorial Chiropractic College