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Effects of Spinal Manipulation on Vertebrobasilar and Internal Carotis Arteries in Healthy Population

Primary Purpose

Vertebral Artery Dissection, Traumatic, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Doppler Ultrasonography
Manual Chiropractic Spinal Manipulation
Instrumental Chiropractic Spinal Manipulation
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Vertebral Artery Dissection, Traumatic focused on measuring Chiropractic, Manipulation, Vertebrobasilar Artery

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Maslak Acıbadem Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manual Chiropractic Spinal Manipulation

Instrumental Chiropractic Spinal Manipulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Peak Systolic Velocity (PSV)
cm/s, measured in each group
Change in End Diastolic Velocity (EDV)
cm/s, measured in each group
Change in Resistive Index (RI)
The Formula: RI = (PSV- EDV) / PSV, it has no unit, measured in each group
Change in Volume Flow (VF)
ml/min, measured only for right and left vertebral arteries

Secondary Outcome Measures

Full Information

First Posted
January 3, 2018
Last Updated
February 14, 2018
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT03435159
Brief Title
Effects of Spinal Manipulation on Vertebrobasilar and Internal Carotis Arteries in Healthy Population
Official Title
Comparison the Effects of Manual and Instrumental Chiropractic Spinal Manipulation on Vertebrobasilar and Internal Carotis Arteries in Healthy Population
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
April 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Artery Dissection, Traumatic, Neck Pain
Keywords
Chiropractic, Manipulation, Vertebrobasilar Artery

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Chiropractic Spinal Manipulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Instrumental Chiropractic Spinal Manipulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Doppler Ultrasonography
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Manual Chiropractic Spinal Manipulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Instrumental Chiropractic Spinal Manipulation
Other Intervention Name(s)
Activator technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Peak Systolic Velocity (PSV)
Description
cm/s, measured in each group
Time Frame
1 minute
Title
Change in End Diastolic Velocity (EDV)
Description
cm/s, measured in each group
Time Frame
1 minute
Title
Change in Resistive Index (RI)
Description
The Formula: RI = (PSV- EDV) / PSV, it has no unit, measured in each group
Time Frame
1 minute
Title
Change in Volume Flow (VF)
Description
ml/min, measured only for right and left vertebral arteries
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Maslak Acıbadem Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
20618936
Citation
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.
Results Reference
background
PubMed Identifier
16623934
Citation
Gemmell 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.
Results Reference
background
PubMed Identifier
18204390
Citation
Cassidy 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. Erratum In: Spine (Phila Pa 1976). 2010 Mar 1;35(5):595.
Results Reference
background

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Effects of Spinal Manipulation on Vertebrobasilar and Internal Carotis Arteries in Healthy Population

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