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临床试验/NCT03435159
NCT03435159已完成不适用

Comparison the Effects of Manual and Instrumental Chiropractic Spinal Manipulation on Vertebrobasilar and Internal Carotis Arteries in Healthy Population

Bahçeşehir University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Change in Peak Systolic Velocity (PSV)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Manual Chiropractic Spinal Manipulation (Procedure)

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.

干预措施: Doppler Ultrasonography (Diagnostic Test)

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.

干预措施: Doppler Ultrasonography (Diagnostic Test)

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.

干预措施: Instrumental Chiropractic Spinal Manipulation (Device)

结局指标

主要结局

Change in Peak Systolic Velocity (PSV)

时间窗: 1 minute

cm/s, measured in each group

Change in End Diastolic Velocity (EDV)

时间窗: 1 minute

cm/s, measured in each group

Change in Resistive Index (RI)

时间窗: 1 minute

The Formula: RI = (PSV- EDV) / PSV, it has no unit, measured in each group

Change in Volume Flow (VF)

时间窗: 1 minute

ml/min, measured only for right and left vertebral arteries

次要结局

未报告次要终点

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcu Özdemir Kocabey

PhD student, Physical Therapist

Bahçeşehir University

研究点 (1)

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