Vertebral Artery Dissection, TraumaticNCT03435159
Effects of Spinal Manipulation on Vertebrobasilar and Internal Carotis Arteries in Healthy Population
A study testing Doppler Ultrasonography, Manual Chiropractic Spinal Manipulation and Instrumental Chiropractic Spinal Manipulation in people with Vertebral Artery Dissection, Traumatic and Neck Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
After lumbar pain, neck pain is the most common cause of patients needing chiropractic care; the second most common cause of spinal manipulation use (1). Manipulation and mobilization are commonly used by chiropractors, osteopaths and manipulative physiotherapists in the treatment of neck pain. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vertebral Artery Dissection, Traumatic, Neck Pain
- What is being tested?
- Doppler Ultrasonography, Manual Chiropractic Spinal Manipulation and Instrumental Chiropractic Spinal Manipulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2017to 28 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between 20-40 years of age
- Having non-specific mechanical neck pain for more than 3 months with symptoms provoked by neck postures, movements, or palpation
- Willingly participating to the study
- Signing the confirmation form.
Who cannot join
- Spinal root compression (radiculopathy)
- Neurological symptoms like weakness and numbness in extremities and face, uncontrolled movements, abnormal gait, dizziness, undefined nausea/vomiting, swallowing and speaking difficulties
- Acute inflammatory disease
- Spontaneously vertebral artery dissection in family
- Tested positive in premanipulative vertebrobasilar artery insufficiency test
- Being on anticoagulant and antiaggregant medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison the Effects of Manual and Instrumental Chiropractic Spinal Manipulation on Vertebrobasilar and Internal Carotis Arteries in Healthy Population
After lumbar pain, neck pain is the most common cause of patients needing chiropractic care; the second most common cause of spinal manipulation use (1). Manipulation and mobilization are commonly used by chiropractors, osteopaths and manipulative physiotherapists in the treatment of neck pain. Many studies show that the Activator instrument is also used for this purpose in the chiropractic profession (2) There are several published case reports that relate to neck manipulation to vertebral artery dissection and stroke. The prevailing theory is that the neck extension and / or rotation may damage the vertebral artery in the foramen transversarium, especially at the C1-C2 level (2). However, most cases of extracranial vertebral artery dissection are thought to be spontaneous (3).
In the literature, there have been no studies investigating the effects of instrument-assisted spinal manipulation on vertebrobasilar and internal carotis arteries. the aim of this study to compare the effect of manual and instrumental spinal manipulation on blood flow parameters of vertebrobasilar and internal carotis arteries on healthy persons which have mechanical neck pain and asymptomatic in vertebrobasilar insufficiency test.
- Conditions
- Vertebral Artery Dissection, Traumatic, Neck Pain
- Being tested
- Doppler Ultrasonography, Manual Chiropractic Spinal Manipulation, Instrumental Chiropractic Spinal Manipulation
- Keywords
- Chiropractic, Manipulation, Vertebrobasilar Artery
- Medical subject headings
- Vertebral Artery Dissection, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler UltrasonographyDiagnostic test
GE LOGIQ S8 ultrasound machine was used to measure blood flow parameters in right and left a. carotis communis, a. carotis interna and a. vertebralis. All vessels were examined in the axial plane through their traces in the B-mode with a C6-15 MHz curvilinear matrix probe. Flow patterns and directions of vessels were then examined with Colour Doppler and it was determined whether there was any stenosis. Intimal thickness of a. carotis communis was measured by spectral doppler method. Measurements were recorded by visualizing the CCA at the supraclavicular level, the ICA carotid sinus (C4 level), and the VA at the V2 segment (C3-4 level), with less angle at 60 degrees. All measurements before and after the application were made at the same level. Immediately after manipulation, blood flow parameters were recorded as numerical data by the same physician again with Doppler USG of the relevant arteries.
Manual Chiropractic Spinal ManipulationProcedure or surgery
Manipulation procedures were applied to C1 or C2 (atlas and axis) vertebrae once in each participant. The application to which vertebrae were applied was determined by the palpation method applied by the physiotherapist. Manual chiropractic manipulation for C1 vertebra was applied in sitting position, using the "digit / atlas pull" technique. This technique is applied with the contact of practitioner's middle finger to the posterior part of transverse process of atlas, and generate a rotation force between C1 and C2 vertebrae.
The procedure was applied to C2 vertebra using the "index / facet push" technique in the supine position. This technique places pushing force in the direction of rotation between the C2-C3 vertebrae, placing the practitioner's index finger in contact with the posterior surface of the C2 facet joint.
Instrumental Chiropractic Spinal ManipulationDevice
Also called Activator technique
Activator technique was applied to C1 or C2 (atlas and axis) vertebrae once in each participant. The application to which vertebrae were applied was determined by the palpation method applied by the physiotherapist. Instrumental spinal manipulation was applied with Activator V chiropractic instrument. For C1 vertebra, the procedure was applied in supine position, by placing the Activator device horizontally on the participant's atlas transverse process of the affected side and applying a pushing force in the medial direction.
For C2 vertebra, the procedure was applied in prone position, by placing the Activator device in the relevant C2 pedicle-lamina junction of the participant's affected side and applying a pushing force in the anterior, superior and mild medial direction of movement of the facet joint.
| Study group | Role | What they receive |
|---|---|---|
| Manual Chiropractic Spinal Manipulation | Experimental | Demographic informations, pain, previous trauma, diseases, current medicine, past surgical operations, pregnancy, smoking use and cervical artery dissection history in family are questioned. Cervical flexion, extension, right and left rotations, right and left lateral flexions are measured by physiotherapist, in sitting position and with goniometer.Upper extremity muscle strength was measured with manual muscle testing in sitting position by physical therapist. The muscles innervated by C4, C5, C6, C7, C8 and T1 cervical nerves were examined bilaterally. Cervical foraminal compression test was used to eliminate cervical root compression.Vertebrobasilar artery was assessed by premanipulative vertebrobasilar insufficiency test.Neck Disability Index was used to evaluate the functional neck status of the participants. After all assessments, participants who were eligible for this study were undertaken Doppler Ultrasonography before and after manual manipulative intervention. Receives: Diagnostic Test: Doppler Ultrasonography; Procedure: Manual Chiropractic Spinal Manipulation |
| Instrumental Chiropractic Spinal Manipulation | Experimental | The same assessments were applied to determine the eligibility of participants for this study. After all assessments, participants who were eligible for this study were undertaken Doppler Ultrasonography before and after instrumental manipulative intervention. Receives: Diagnostic Test: Doppler Ultrasonography; Device: Instrumental Chiropractic Spinal Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Systolic Velocity (PSV)
cm/s, measured in each group
Measured: 1 minute
Change in End Diastolic Velocity (EDV)
cm/s, measured in each group
Measured: 1 minute
Change in Resistive Index (RI)
The Formula: RI = (PSV- EDV) / PSV, it has no unit, measured in each group
Measured: 1 minute
Change in Volume Flow (VF)
ml/min, measured only for right and left vertebral arteries
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start17 Feb 2017
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vertebral Artery Dissection, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 30 participants were divided into 2 groups. In the first group, participants were applied manual chiropractic manipulation, and in the second group, participants were applied instrumental chiropractic manipulation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Özdemir Kocabey, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435159
- Sponsor's protocol ID
- BahcesehirUni
- Status last verified
- Feb 2018
- First submitted
- 3 Jan 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gemmell H, Miller P. Relative effectiveness and adverse effects of cervical manipulation, mobilisation and the activator instrument in patients with sub-acute non-specific neck pain: results from a stopped randomised trial. Chiropr Osteopat. 2010 Jul 9;18:20. doi: 10.1186/1746-1340-18-20.
PubMed 20618936Gemmell H, Miller P. Comparative effectiveness of manipulation, mobilisation and the activator instrument in treatment of non-specific neck pain: a systematic review. Chiropr Osteopat. 2006 Apr 19;14:7. doi: 10.1186/1746-1340-14-7.
PubMed 16623934Cassidy 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. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S176-83. doi: 10.1097/BRS.0b013e3181644600.
PubMed 18204390
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effects of Manual and Instrumental Chiropractic Spinal Manipulation on Vertebrobasilar and Internal Carotis Arteries in Healthy Population
- ClinicalTrials.gov ID
- NCT03435159
- Acronym / sponsor ID
- BahcesehirUni
- Conditions
- Vertebral Artery Dissection, Traumatic, Neck Pain
- Keywords
- Chiropractic, Manipulation, Vertebrobasilar Artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After lumbar pain, neck pain is the most common cause of patients needing chiropractic care; the second most common cause of spinal manipulation use (1). Manipulation and mobilization are commonly used by chiropractors, osteopaths and manipulative physiotherapists in the treatment of neck pain. Many studies show that the Activator instrument is also used for this purpose in the chiropractic profession (2) There are several published case reports that relate to neck manipulation to vertebral artery dissection and stroke. The prevailing theory is that the neck extension and / or rotation may damage the vertebral artery in the foramen transversarium, especially at the C1-C2 level (2). However, most cases of extracranial vertebral artery dissection are thought to be spontaneous (3).
In the literature, there have been no studies investigating the effects of instrument-assisted spinal manipulation on vertebrobasilar and internal carotis arteries. the aim of this study to compare the effect of manual and instrumental spinal manipulation on blood flow parameters of vertebrobasilar and internal carotis arteries on healthy persons which have mechanical neck pain and asymptomatic in vertebrobasilar insufficiency test.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 30 participants were divided into 2 groups. In the first group, participants were applied manual chiropractic manipulation, and in the second group, participants were applied instrumental chiropractic manipulation.
| Arm | Type | Receives |
|---|---|---|
| Manual Chiropractic Spinal Manipulation | Experimental | Diagnostic Test: Doppler Ultrasonography, Procedure: Manual Chiropractic Spinal ManipulationDemographic informations, pain, previous trauma, diseases, current medicine, past surgical operations, pregnancy, smoking use and cervical artery dissection history in family are questioned. Cervical flexion, extension, right and left rotations, right and left lateral flexions are measured by physiotherapist, in sitting position and with goniometer.Upper extremity muscle strength was measured with manual muscle testing in sitting position by physical therapist. The muscles innervated by C4, C5, C6, C7, C8 and T1 cervical nerves were examined bilaterally. Cervical foraminal compression test was used to eliminate cervical root compression.Vertebrobasilar artery was assessed by premanipulative vertebrobasilar insufficiency test.Neck Disability Index was used to evaluate the functional neck status of the participants. After all assessments, participants who were eligible for this study were undertaken Doppler Ultrasonography before and after manual manipulative intervention. |
| Instrumental Chiropractic Spinal Manipulation | Experimental | Diagnostic Test: Doppler Ultrasonography, Device: Instrumental Chiropractic Spinal ManipulationThe same assessments were applied to determine the eligibility of participants for this study. After all assessments, participants who were eligible for this study were undertaken Doppler Ultrasonography before and after instrumental manipulative intervention. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between 20-40 years of age
- Having non-specific mechanical neck pain for more than 3 months with symptoms provoked by neck postures, movements, or palpation
- Willingly participating to the study
- Signing the confirmation form.
Key exclusion criteria (6 listed)
- Spinal root compression (radiculopathy)
- Neurological symptoms like weakness and numbness in extremities and face, uncontrolled movements, abnormal gait, dizziness, undefined nausea/vomiting, swallowing and speaking difficulties
- Acute inflammatory disease
- Spontaneously vertebral artery dissection in family
- Tested positive in premanipulative vertebrobasilar artery insufficiency test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler UltrasonographyGE LOGIQ S8 ultrasound machine was used to measure blood flow parameters in right and left a. carotis communis, a. carotis interna and a. vertebralis. All vessels were examined in the axial plane through their traces in the B-mode with a C6-15 MHz curvilinear matrix probe. Flow patterns and directions of vessels were then examined with Colour Doppler and it was determined whether there was any stenosis. Intimal thickness of a. carotis communis was measured by spectral doppler method. Measurements were recorded by visualizing the CCA at the supraclavicular level, the ICA carotid sinus (C4 level), and the VA at the V2 segment (C3-4 level), with less angle at 60 degrees. All measurements before and after the application were made at the same level. Immediately after manipulation, blood flow parameters were recorded as numerical data by the same physician again with Doppler USG of the relevant arteries. | Diagnostic test | Instrumental Chiropractic Spinal Manipulation, Manual Chiropractic Spinal Manipulation |
| Manual Chiropractic Spinal ManipulationManipulation procedures were applied to C1 or C2 (atlas and axis) vertebrae once in each participant. The application to which vertebrae were applied was determined by the palpation method applied by the physiotherapist. Manual chiropractic manipulation for C1 vertebra was applied in sitting position, using the "digit / atlas pull" technique. This technique is applied with the contact of practitioner's middle finger to the posterior part of transverse process of atlas, and generate a rotation force between C1 and C2 vertebrae. The procedure was applied to C2 vertebra using the "index / facet push" technique in the supine position. This technique places pushing force in the direction of rotation between the C2-C3 vertebrae, placing the practitioner's index finger in contact with the posterior surface of the C2 facet joint. | Procedure or surgery | Manual Chiropractic Spinal Manipulation |
| Instrumental Chiropractic Spinal ManipulationAlso: Activator techniqueActivator technique was applied to C1 or C2 (atlas and axis) vertebrae once in each participant. The application to which vertebrae were applied was determined by the palpation method applied by the physiotherapist. Instrumental spinal manipulation was applied with Activator V chiropractic instrument. For C1 vertebra, the procedure was applied in supine position, by placing the Activator device horizontally on the participant's atlas transverse process of the affected side and applying a pushing force in the medial direction. For C2 vertebra, the procedure was applied in prone position, by placing the Activator device in the relevant C2 pedicle-lamina junction of the participant's affected side and applying a pushing force in the anterior, superior and mild medial direction of movement of the facet joint. | Device | Instrumental Chiropractic Spinal Manipulation |
Primary outcome
Change in Peak Systolic Velocity (PSV)
Time frame: 1 minute
cm/s, measured in each group
Change in End Diastolic Velocity (EDV)
Time frame: 1 minute
cm/s, measured in each group
Change in Resistive Index (RI)
Time frame: 1 minute
The Formula: RI = (PSV- EDV) / PSV, it has no unit, measured in each group
Change in Volume Flow (VF)
Time frame: 1 minute
ml/min, measured only for right and left vertebral arteries
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Background: PubMed 20618936Gemmell H, Miller P. Relative effectiveness and adverse effects of cervical manipulation, mobilisation and the activator instrument in patients with sub-acute non-specific neck pain: results from a stopped randomised trial. Chiropr Osteopat. 2010 Jul 9;18:20. doi: 10.1186/1746-1340-18-20.
- Background: PubMed 16623934Gemmell H, Miller P. Comparative effectiveness of manipulation, mobilisation and the activator instrument in treatment of non-specific neck pain: a systematic review. Chiropr Osteopat. 2006 Apr 19;14:7. doi: 10.1186/1746-1340-14-7.
- Background: PubMed 18204390Cassidy 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. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S176-83. doi: 10.1097/BRS.0b013e3181644600.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler Ultrasonography, Manual Chiropractic Spinal Manipulation and Instrumental Chiropractic Spinal Manipulation in people with Vertebral Artery Dissection, Traumatic and Neck Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Systolic Velocity (PSV) (time frame: 1 minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03435159, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.