NCT03464214

Brief Summary

In healthy individuals, many postural musculoskeletal problems arise due to various reasons. The cervical region is the region where these problems are most common. The cervical region ranks second in the general population after the lumbal area of musculoskeletal system disorders and affects close to 70% of the general population.The most important causes of this posture disorder are; muscular performance and strength are inadequate, as well as decreased proprioception of the muscles, deterioration of the individual balance systems that result in individual visual or vestibular problems. Exercise therapy is at the forefront of these methods, while a variety of methods are applied in the prevention and treatment of neck problems. Recent studies have focused on multifaceted treatments including exercises to improve strength, endurance and coordination of cervical muscles, proprioceptive training, relaxation exercises to prevent muscle tension, stabilization exercises and behavior modification. Cervical stabilization exercises are a frequently used exercise approach. Cervical stabilization exercises, which are different from ordinary exercises, are based on biomechanics, neurophysiology and physiotherapy research. The main objective of this method is; improve body awareness, maintain posture uniformity, improve strength, endurance, coordination and proprioception. Stabilization exercises also increase the strength and endurance of the postural and stabilizer muscles, improving stability control in the stabilized and non-stabilized positions. Another method that contributes to the development of balance and proprioceptive sense is vibration application. Proprioception plays an important role in ensuring the coordination of movements. When the proprioception input is disturbed, both the position sense and the speed of movement may be affected. Muscle-tendon vibration is a noninvasive method that is often used in proprioception studies. It has been suggested that the vibration application are the enhancing effect of the proprioceptive. However, there is not enough research on this subject. The purpose of this study is to determine whether the cervical stabilization exercises to be applied to the cervical region and the local vibration applied to the neck muscles are related to muscle performance, proprioception and balance and their superiority with each other.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

February 27, 2018

Last Update Submit

December 17, 2018

Conditions

Keywords

VibrationCervical stabilization exercisesPhysiotherapy and rehabilitationSensory organization testBalance

Outcome Measures

Primary Outcomes (1)

  • Sensory Organization Test

    The sensory organization test. The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. SOT was used to assess changes in visual, vestibular, and somatosensory balance of individuals at eighth week.

    SOT was used to assess changes in visual, vestibular, and somatosensory balance of individuals at eighth week.

Secondary Outcomes (1)

  • Head Shake Sensory Organization Test (HS-SOT)

    HS-SOT was used to assess changes only vestibular balance of individuals at eighth week.

Study Arms (3)

Vibration Group

ACTIVE COMPARATOR

Local vibration on neck muscles

Device: Neck Muscle Vibration

Stabilization Group

ACTIVE COMPARATOR

Cervical stabilization exercises on cervical region

Behavioral: Cervical Stabilization Exercises

Control Group

NO INTERVENTION

Individuals performed only daily living activities

Interventions

Local vibration device applied on neck muscles for 8 weeks

Vibration Group

Cervical stabilization exercises performed by healty individuals for 8 weeks

Stabilization Group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals who have not had neck pain in the last six months.

You may not qualify if:

  • Patients with atypical spinal cord anomalies, inflammatory or rheumatologic disorders, malignancy history, radiculopathy, myelopathy or other neurological disorders, vestibular disorders, and vertebral trauma history who underwent any surgical treatment for vertebral colonic at least 3 months before, was not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Boyd-Clark LC, Briggs CA, Galea MP. Muscle spindle distribution, morphology, and density in longus colli and multifidus muscles of the cervical spine. Spine (Phila Pa 1976). 2002 Apr 1;27(7):694-701. doi: 10.1097/00007632-200204010-00005.

  • Peterson BW, Goldberg J, Bilotto G, Fuller JH. Cervicocollic reflex: its dynamic properties and interaction with vestibular reflexes. J Neurophysiol. 1985 Jul;54(1):90-109. doi: 10.1152/jn.1985.54.1.90.

  • Jull GA, Richardson CA. Motor control problems in patients with spinal pain: a new direction for therapeutic exercise. J Manipulative Physiol Ther. 2000 Feb;23(2):115-7.

  • Panjabi MM. The stabilizing system of the spine. Part I. Function, dysfunction, adaptation, and enhancement. J Spinal Disord. 1992 Dec;5(4):383-9; discussion 397. doi: 10.1097/00002517-199212000-00001.

  • Adams M. Re: Spine stability: the six blind men and the elephant. Clin Biomech (Bristol). 2007 May;22(4):486; author reply 487-8. doi: 10.1016/j.clinbiomech.2007.01.001. Epub 2007 Feb 16. No abstract available.

  • Beinert K, Keller M, Taube W. Neck muscle vibration can improve sensorimotor function in patients with neck pain. Spine J. 2015 Mar 1;15(3):514-21. doi: 10.1016/j.spinee.2014.10.013. Epub 2014 Oct 22.

  • Brumagne S, Cordo P, Lysens R, Verschueren S, Swinnen S. The role of paraspinal muscle spindles in lumbosacral position sense in individuals with and without low back pain. Spine (Phila Pa 1976). 2000 Apr 15;25(8):989-94. doi: 10.1097/00007632-200004150-00015.

  • Bosco C, Colli R, Introini E, Cardinale M, Tsarpela O, Madella A, Tihanyi J, Viru A. Adaptive responses of human skeletal muscle to vibration exposure. Clin Physiol. 1999 Mar;19(2):183-7. doi: 10.1046/j.1365-2281.1999.00155.x.

  • Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc Sport Sci Rev. 2003 Jan;31(1):3-7. doi: 10.1097/00003677-200301000-00002.

  • Torvinen S, Kannus P, Sievanen H, Jarvinen TA, Pasanen M, Kontulainen S, Jarvinen TL, Jarvinen M, Oja P, Vuori I. Effect of four-month vertical whole body vibration on performance and balance. Med Sci Sports Exerc. 2002 Sep;34(9):1523-8. doi: 10.1097/00005768-200209000-00020.

  • Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.

  • Cheng CF, Cheng KH, Lee YM, Huang HW, Kuo YH, Lee HJ. Improvement in running economy after 8 weeks of whole-body vibration training. J Strength Cond Res. 2012 Dec;26(12):3349-57. doi: 10.1519/JSC.0b013e31824e0eb1.

  • Yong MS, Lee HY, Ryu YU, Lee MY. Effects of craniocervical flexion exercise on upper-limb postural stability during a goal-directed pointing task. J Phys Ther Sci. 2015 Jun;27(6):2005-7. doi: 10.1589/jpts.27.2005. Epub 2015 Jun 30.

  • Wrisley DM, Stephens MJ, Mosley S, Wojnowski A, Duffy J, Burkard R. Learning effects of repetitive administrations of the sensory organization test in healthy young adults. Arch Phys Med Rehabil. 2007 Aug;88(8):1049-54. doi: 10.1016/j.apmr.2007.05.003.

MeSH Terms

Conditions

Neck PainSomatosensory DisordersVestibular Diseases

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSensation DisordersNervous System DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 13, 2018

Study Start

March 12, 2016

Primary Completion

November 15, 2016

Study Completion

January 2, 2017

Last Updated

December 19, 2018

Record last verified: 2018-12