Clinical trial NCT03435159: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vertebral Artery Dissection, Traumatic
Neck Pain
Keywords: Chiropractic, Manipulation, Vertebrobasilar Artery
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: Change in Peak Systolic Velocity (PSV)
timeFrame: 1 minute
measure: Change in End Diastolic Velocity (EDV)
timeFrame: 1 minute
measure: Change in Resistive Index (RI)
timeFrame: 1 minute
measure: Change in Volume Flow (VF)
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maslak Acıbadem Hospital
Study officials:
References:
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.
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.
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.