Cervical PainNCT03464214
The Effects of Local Vibration and Cervical Stabilization Exercises Applied on Neck Muscles on Balance in Healthy Individuals
A study testing Neck Muscle Vibration and Cervical Stabilization Exercises in people with Cervical Pain and Somatosensory Disorders, run by Hacettepe University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Pain, Somatosensory Disorders, Vestibular Diseases
- What is being tested?
- Neck Muscle Vibration and Cervical Stabilization Exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2016to 2 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals who have not had neck pain in the last six months.
Who cannot join
- 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.
About this study
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.
Read more
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.
- Conditions
- Cervical Pain, Somatosensory Disorders, Vestibular Diseases
- Being tested
- Neck Muscle Vibration, Cervical Stabilization Exercises
- Keywords
- Vibration, Cervical stabilization exercises, Physiotherapy and rehabilitation, Sensory organization test, Balance
- Medical subject headings
- Neck Pain, Somatosensory Disorders, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck Muscle VibrationDevice
Local vibration device applied on neck muscles for 8 weeks
Cervical Stabilization ExercisesBehavioural
Cervical stabilization exercises performed by healty individuals for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vibration Group | Active comparator | Local vibration on neck muscles Receives: Device: Neck Muscle Vibration |
| Stabilization Group | Active comparator | Cervical stabilization exercises on cervical region Receives: Behavioral: Cervical Stabilization Exercises |
| Control Group | No intervention | Individuals performed only daily living activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
This test is applied in the second and fifth cases of the standard Sensory Organization Test, with eyes closed for events, with the task of shaking the head.
Measured: HS-SOT was used to assess changes only vestibular balance of individuals at eighth week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start12 Mar 2016
- Primary completion15 Nov 2016
- Study completion2 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Turkmen, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464214
- Sponsor's protocol ID
- GO 15/716-04
- Status last verified
- Dec 2018
- First submitted
- 27 Feb 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11923661Peterson 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.
PubMed 3162006Jull 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.
PubMed 10714539Panjabi 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.
PubMed 1490034Adams 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.
PubMed 17306912Beinert 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.
PubMed 25452010Brumagne 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.
PubMed 10767813Bosco 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.
PubMed 10200901Cardinale 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.
PubMed 12562163Torvinen 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.
PubMed 12218749Bruyere 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.
PubMed 15706558Cheng 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.
PubMed 22344045Yong 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.
PubMed 26180368Wrisley 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.
PubMed 17678669
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Local Vibration and Cervical Stabilization Exercises Applied on Neck Muscles on Balance in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03464214
- Acronym / sponsor ID
- GO 15/716-04
- Conditions
- Cervical Pain, Somatosensory Disorders, Vestibular Diseases
- Keywords
- Vibration, Cervical stabilization exercises, Physiotherapy and rehabilitation, Sensory organization test, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 12 Mar 2016 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 2 Jan 2017 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vibration Group | Active comparator | Device: Neck Muscle VibrationLocal vibration on neck muscles |
| Stabilization Group | Active comparator | Behavioral: Cervical Stabilization ExercisesCervical stabilization exercises on cervical region |
| Control Group | No intervention | –Individuals performed only daily living activities |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals who have not had neck pain in the last six months.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck Muscle VibrationLocal vibration device applied on neck muscles for 8 weeks | Device | Vibration Group |
| Cervical Stabilization ExercisesCervical stabilization exercises performed by healty individuals for 8 weeks | Behavioural | Stabilization Group |
Primary outcome
Sensory Organization Test
Time frame: SOT was used to assess changes in visual, vestibular, and somatosensory balance of individuals at eighth week.
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.
1 secondary outcome
Head Shake Sensory Organization Test (HS-SOT)
Time frame: HS-SOT was used to assess changes only vestibular balance of individuals at eighth week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Results publication: PubMed 11923661Boyd-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.
- Results publication: PubMed 3162006Peterson 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.
- Results publication: PubMed 10714539Jull 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.
- Results publication: PubMed 1490034Panjabi 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.
- Results publication: PubMed 17306912Adams 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.
- Results publication: PubMed 25452010Beinert 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.
- Results publication: PubMed 10767813Brumagne 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.
- Results publication: PubMed 10200901Bosco 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.
- Results publication: PubMed 12562163Cardinale 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.
- Results publication: PubMed 12218749Torvinen 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.
- Results publication: PubMed 15706558Bruyere 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.
- Results publication: PubMed 22344045Cheng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neck Muscle Vibration and Cervical Stabilization Exercises in people with Cervical Pain and Somatosensory Disorders, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Organization Test (time frame: SOT was used to assess changes in visual, vestibular, and somatosensory balance of individuals at eighth week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03464214, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.