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

February 14, 2018 updated by: Burcu Özdemir Kocabey, Bahçeşehir University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Maslak Acıbadem Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual Chiropractic Spinal Manipulation
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.
Diagnostic test: Doppler Ultrasonography
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.
Procedure: Manual Chiropractic Spinal Manipulation

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.
Experimental: Instrumental Chiropractic Spinal Manipulation
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.
Diagnostic test: Doppler Ultrasonography
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.
Device: Instrumental Chiropractic Spinal Manipulation

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.

Other Names:
  • Activator technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Peak Systolic Velocity (PSV)
Time Frame: 1 minute
cm/s, measured in each group
1 minute
Change in End Diastolic Velocity (EDV)
Time Frame: 1 minute
cm/s, measured in each group
1 minute
Change in Resistive Index (RI)
Time Frame: 1 minute
The Formula: RI = (PSV- EDV) / PSV, it has no unit, measured in each group
1 minute
Change in Volume Flow (VF)
Time Frame: 1 minute
ml/min, measured only for right and left vertebral arteries
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahçeşehir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2017

Primary Completion (Actual)

April 28, 2017

Study Completion (Actual)

April 28, 2017

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BahcesehirUni

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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