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Neck PainNCT06802601

Effect of Visio-Vestibular Exercises on Pain, Function, Balance, and Reaction Time in Chronic Neck Pain

A study testing Manual Therapy and Exercise and Manual Therapy, Exercise and Visio-Vestibular Exercise in people with Neck Pain and Chronic Neck Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Neck Pain, Chronic Neck Pain
What is being tested?
Manual Therapy and Exercise and Manual Therapy, Exercise and Visio-Vestibular Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Oct 2024to 1 Jun 2025
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir Katip Celebi Univeristy

    Izmir, Cigli

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Manual Therapy and Exercise, Manual Therapy, Exercise and Visio-Vestibular Exercise
Keywords
Manual Therapy, Neck Pain
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual Therapy and ExerciseOther

    Manual Therapy and Exercise

  • Manual Therapy, Exercise and Visio-Vestibular ExerciseOther

    Manual Therapy, Exercise and Visio-Vestibular Exercise

Study groups in NCT06802601
Study groupRoleWhat they receive
Manuel Therapy and Stabilization ExercisesActive comparatorNot described
Receives: Other: Manual Therapy and Exercise
Manuel Therapy and Stabilization Exercises plus Visio-Vestibular ExercisesExperimentalNot described
Receives: Other: Manual Therapy, Exercise and Visio-Vestibular Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain

    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.

    Measured: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  2. Cervical Range of Motion

    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.

    Measured: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  3. Function

    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.

    Measured: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

Secondary outcomes (6)
  1. Pressure Pain Threshold

    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

    Measured: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  2. Balance

    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.

    Measured: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  3. Reaction Time

    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.

    Measured: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  4. The Cervical Flexor Endurance Test

    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.

    Measured: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  5. Cervical Extensor Endurance Test

    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.

    Measured: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

  6. Quality of Life

    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.

    Measured: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start28 Oct 2024
  3. Primary completion21 May 2025
  4. Study completion1 Jun 2025

Resources

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
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06802601
Sponsor's protocol ID
1620
Status last verified
Sep 2025
First submitted
16 Jan 2025
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 3490396
  • 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.

    PubMed 19411769
  • Tanik F, Altas EU, Ozer Kaya D. The effect of combining visuo-vestibular exercises with manual therapy and exercise on sensorimotor function in chronic neck pain: A randomized controlled trial. Gait Posture. 2026 Oct;130:110604. doi: 10.1016/j.gaitpost.2026.110604. Epub 2026 Jul 30.

    PubMed 42541826

Questions about this trial

What is this clinical trial studying?

A study testing Manual Therapy and Exercise and Manual Therapy, Exercise and Visio-Vestibular Exercise in people with Neck Pain and Chronic Neck Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

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 4 inclusion and 8 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 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Pain (time frame: From enrollment to the end of treatment at week 6. Follow-up assessment 6 weeks after the end of treatment.). The study lists 3 primary outcomes in all. 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 NCT06802601, which also lists 3 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 10 Sep 2025.

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