- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06802601
Effect of Visio-Vestibular Exercises on Pain, Function, Balance, and Reaction Time in Chronic Neck Pain
The Effect of Visio-Vestibular Exercises Applied in Addition to Manual Therapy and Exercise on Pain, Function, Balance and Reaction Time in Chronic Neck Pain: A Randomized Controlled Study
The aim of the study was to improve pain, function, balance and reaction times in people with chronic neck pain by stimulating and improving the components that provide input to the central nervous system (proprioceptive, visual, vestibular) through manual therapy and exercise and to reveal the results of vizio-vestibular training applied in addition to manual therapy and exercise. Therefore, the hypotheses of this study were;
H1: Manual therapy and exercise have a positive effect on pain, function, balance and reaction time in people with chronic neck pain.
H2: Vizio-vestibular exercises given in addition to manual therapy and exercise have a positive effect on pain, function, balance and reaction time in people with chronic neck pain.
H3: There is no difference between the effects of manual therapy and exercise and viziovestibular exercises in addition to manual therapy and exercise on pain, function, balance and reaction time in people with chronic neck pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neck pain is defined by the International Association for the Study of Pain (IASP) as pain felt in the area between the occiput and the first thoracic vertebra. Neck pain is a multifactorial disorder and is a major problem in modern society. In 2016, among 154 conditions, low back and neck pain had the highest healthcare expenditure in the United States with an estimated $134.5 billion. In 2012, neck pain was responsible for 25.5 million Americans being absent from work, missing an average of 11.4 days. In 2017, the global age-standardized prevalence and incidence rates of neck pain were 3551.1 and 806.6 per 100,000, respectively.
The cervical spine, especially the upper cervical spine, is the most mobile part of the vertebral column. The highly developed proprioceptive system provides neuromuscular control to the mobile cervical spine and allows efficient utilization of vital organs in the head through unique connections to the vestibular and visual systems. In people with neck pain, disturbances in afferent input from the cervical region may be a possible cause of symptoms such as dizziness, imbalance and visual disturbances, as well as signs of altered postural stability, cervical proprioception and head and eye movement control. For neck pain patients with minimal sensorimotor proprioceptive impairments, conventional treatment approaches may be sufficient. However, clinical experience and research suggest that significant sensorimotor proprioceptive impairments in the cervical spine may be an important factor in the maintenance, relapse or progression of various symptoms in patients with neck pain.
The postural control system includes all sensorimotor and musculoskeletal components involved in the control of 2 important behavioral goals: postural orientation and postural balance. Postural orientation is the relative positioning of body segments relative to each other and to the environment; postural balance is the state in which all forces acting on the body tend to keep the body in a desired position and orientation (static balance) or to move it in a controlled manner (dynamic balance). Postural control provides a stable body platform for efficient execution of goal-directed movements. The somatosensory, vestibular and visual systems are subsystems that provide sensory input to the postural control system.
The Somatosensory System encompasses all mechanoreceptive information from the periphery that leads to the perception of pain, temperature, touch and proprioception. In particular, the proprioceptive system of the cervical spine is highly developed thanks to the large number of mechanoreceptors from the γ-muscle spindles in the deep segmental upper cervical muscles. The γ-muscle spindle system serves as the last common pathway for the regulation of muscle stiffness required for various neuromuscular performances. The dense network of mechanoreceptors in the soft tissues in this region not only controls the movements of each joint, but more importantly, through direct neurophysiological connections to the vestibular and visual systems, informs the Central Nervous System about the orientation of the head relative to the rest of the body. Somatosensory information from the cervical region is the only region with such direct access to the senses of balance and vision.
The Vestibular Subsystem is specifically designed to maintain adequate postural tone in the trunk and limb muscles to ensure overall balance during posture and movement. Neck, eye, trunk and limb muscle reflexes have evolved to meet these requirements. Specialized mechanoreceptors in the semicircular canals become sensitive during changes in the speed of movement, i.e. angular velocity, and specialized mechanoreceptors in the otolith systems of the utricular and saccular maculae provide information about the position and velocity of the head relative to the direction of gravitational forces. Sensory information from the vestibular system is integrated via the vestibular nerve in all the nuclei that make up the vestibular nuclear complex and in the cerebellum.
The Visual Subsystem plays a dominant role in the guidance of movements and this is reflected by the fact that when there is a mismatch between somatosensory inputs and vision, the visual version of events usually prevails. The visual postural system consists of 3 different eye movement systems: the smooth pursuit system, the saccadic system and the optokinetic system. The smooth pursuit system stabilizes images of smoothly moving targets on the fovea with slow eye movements. The saccadic system is responsible for rapid and small movements of both eyes simultaneously when changing a fixation point. The optokinetic system stabilizes images on the entire retina when the entire visual field moves (e.g. when walking).
The aim of the study was to improve pain, function, balance and reaction times in people with chronic neck pain by stimulating and improving the components that provide input to the central nervous system (proprioceptive, visual, vestibular) through manual therapy and exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cigli
-
Izmir, Cigli, Turkey (Türkiye)
- Izmir Katip Celebi Univeristy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be between the ages of 18 and 55
- Complaining of neck pain for at least 3 months or experiencing neck pain at least 2 times in 3 months
- Volunteering for the study
- To be able to read and understand Turkish
Exclusion Criteria:
- Previous history of neck and head trauma or surgery
- Vertigo or dizziness caused by known or suspected vestibular pathology, ear or brain disorders, sensory nerve pathways (e.g. BPPV) or vascular disorders (e.g. migraine, hypertension)
- Any musculoskeletal or neurological condition that may affect balance
- Inflammatory joint disease
- Cognitive impairment
- Taking four or more medicines
- Received physiotherapy treatment for neck pain in the last 12 months
- People with strabismus, lazy eye and severe refractive errors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Manuel Therapy and Stabilization Exercises
|
Manual Therapy and Exercise
|
|
Experimental: Manuel Therapy and Stabilization Exercises plus Visio-Vestibular Exercises
|
Manual Therapy, Exercise and Visio-Vestibular Exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
Pain intensity will be questioned with the Visual Analog Scale.
The Visual Analog Scale pain assessment scale was first used by Hayes and Patterson in 1921.
It measures the severity of pain based on the patient's statement.
A straight thin 10 cm line is used.
0 is defined as "no pain" and 10 as "unbearable pain".
The patient is asked to mark the point on the line describing the pain.
The length of the distance indicates the severity of the patient's pain.
|
From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
|
Cervical Range of Motion
Time Frame: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
Goniometric measurement is used in the clinic as an objective measurement tool for the assessment of active range of motion.
Goniometer is a durable, simple, easy-to-carry device that can be easily used in almost all joints.
Neck flexion, extension, lateral flexion and rotation movements will be evaluated with goniometer.
|
From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
|
Function
Time Frame: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
The Neck and Neck Disability Index will be used to assess the level of function in people with neck pain.
The questionnaire, whose Turkish validity and reliability study was conducted by Aslan et al. consists of 10 items.
Each item is scored from 0 (no disability) to 5 (complete disability).
The total score is between 0 (no disability) and 50 (total disability).
Disability increases with increasing score and decreases with decreasing score.
|
From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold
Time Frame: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
The pressure value is obtained by pressing a dynamic metal piston with a round disk with a surface area of 1 cm² at its tip into the relevant area.
Under the influence of the pressure applied by the metal piston, the hand on the dial moves clockwise.
When the algometer leaves the relevant area, the last measured value on the hand is recorded and the zero button is pressed.
Thus, the instrument is made ready for further measurements.
While applying pressure to the relevant points with the algometer, patients will be asked to say "stop" at the first moment when the feeling of pressure causes discomfort.
At the first moment when the patients feel pain, the application of pressure will be stopped and the pressure value at that moment will be recorded.
A total of 3 measurements will be made for each marked point with a 30 sec.
rest interval between each measurement.
Afterwards, the average pressure pain threshold values will be recorded.
In this direction, the Trapezius, Biceps Brachi
|
From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
|
Balance
Time Frame: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
Static, eyes open-eyes closed and stability limits will be evaluated with a computerized balance device.
The device consists of a computer and a balance platform.
The individual will be asked to step on the platform barefoot and step on the designated areas.
For static balance with eyes open and eyes closed, the individual will be asked to stand on the device for 30 seconds without speaking and moving as stably as possible.
Balance results with eyes open and eyes closed will be recorded in square millimeters and anteroposterior and medio-lateral deviation values will be recorded in millimeters.
For the stability limit, it will be asked to try to reach 4 different points by transferring the body weight in 4 different directions in a 360-degree circle on the screen.
The limits he/she can reach will be recorded in degrees.
|
From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
|
Reaction Time
Time Frame: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
Reaction time measurements of the upper extremities will be performed on the dominant side, non-dominant side and bilaterally with the "Test You Brain Pro" system.
Measurements will be made with the help of a device containing visual/auditory and perceptual/cognitive tasks.
Using a program with sound, light and variable timer, the participant will be asked to follow the stimuli, hand contact with the light will be monitored and the time until the program ends will be recorded.
|
From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
|
The Cervical Flexor Endurance Test
Time Frame: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
The Cervical Flexor Endurance Test is a test that measures the endurance of participants' deep neck flexors.
The participant lies supine on the bed without a pillow.
The participant is asked to keep the occiput 2.5 cm above the bed while maintaining the neck position.
When the participant starts the test, the time is started and stopped when the participant cannot control the occiput.
|
From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
|
Cervical Extensor Endurance Test
Time Frame: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
The cervical extensor endurance test aims to be able to determine the weakness of both the superficial and deep neck extensors.
With the participant lying prone, the head and neck past the edge of the table and the cervicothoracic region stabilized, the patient is asked to maintain a neutral head position.
At the beginning of the test, the test is timed with a chronimeter and terminated when the participant is unable to maintain the position.
|
From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
|
Quality of Life
Time Frame: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
The Short Form-36 (SF-36) is a test consisting of 8 sub-parameters and 36 items that the participant fills in and answers by himself/herself to obtain information about the health status of the person.
Scoring is based on 100 points and the scores are between 0 and 100 points for each sub-parameter.
"0" is calculated as the worst value and '100' as the best value.
|
From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kristjansson E, Treleaven J. Sensorimotor function and dizziness in neck pain: implications for assessment and management. J Orthop Sports Phys Ther. 2009 May;39(5):364-77. doi: 10.2519/jospt.2009.2834.
- Guitton D, Kearney RE, Wereley N, Peterson BW. Visual, vestibular and voluntary contributions to human head stabilization. Exp Brain Res. 1986;64(1):59-69. doi: 10.1007/BF00238201.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neck Pain
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Exercise
- Musculoskeletal Manipulations
Other Study ID Numbers
- 1620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Neck Pain
-
Hochschule OsnabruckNot yet recruitingNeck Pain | Chronic Neck Pain | Neck Disability | Neck Pain Musculoskeletal | Neck Disease
-
Istanbul University - CerrahpasaRecruitingNonspecific Neck Pain | Neck Pain MusculoskeletalTurkey (Türkiye)
-
Universitat Internacional de CatalunyaNot yet recruitingChronic Neck Pain | Non-specific Neck PainSpain
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
Benha UniversityCompletedNeck Pain | Mechanical Neck Pain | Pain Threshold | Cervical Pain, Posterior | Neck Pain Musculoskeletal | Extracorporeal Shock Wave TherapyEgypt
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
University of LahoreCompletedNeck Pain | Mechanical Neck Pain | Mobilization | Neck Pain Musculoskeletal | Proprioceptive Neuromuscular FacilitationPakistan
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Hacettepe UniversityNot yet recruitingChronic Neck PainTurkey (Türkiye)
-
Istanbul Rumeli UniversityEnrolling by invitationNeck Pain | Neck Pain MusculoskeletalTurkey (Türkiye)
Clinical Trials on Manual Therapy and Exercise
-
Proaxis TherapyVirginia Commonwealth University; Arcadia University; National Athletic Trainers...CompletedShoulder Impingement SyndromeUnited States
-
Josue Fernandez CarneroUniversidad Autonoma de MadridCompletedCervicalgia | Neck Pains | Posterior Cervical Pains | Posterior Neck Pain
-
University of AlcalaNot yet recruiting
-
Alabama Physical Therapy & AcupunctureUniversidad Rey Juan CarlosRecruitingEpicondylalgiaUnited States
-
Royal College of Surgeons, IrelandUnknownHip OsteoarthritisIreland
-
Universidad de ZaragozaCompleted
-
University of AlcalaRecruitingTemporomandibular DisorderSpain
-
Des Moines UniversityWalsh University; Youngstown State UniversityCompleted
-
Universitat Internacional de CatalunyaRecruiting
-
Hasan Kalyoncu UniversityCompletedTemporomandibular Disorders | Dysphagia, Oral PhaseTurkey