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Chronic Neck PainNCT05083858

Effect of Cervical Stabilization and Oculomotor Exercises on Position Sense With Chronic Neck Pain

A study testing Classical Physiotherapy Program + Cervical Stabilization Exercises, Classical Physiotherapy Program + Oculomotor Exercises and Classical Physiotherapy Program in people with Chronic Neck Pain and Exercise Addiction, run by Eastern Mediterranean University at 1 site in Cyprus.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to compare the effectiveness of Cervical Stabilization and Oculomotor Exercises in addition to the classical physiotherapy on pain severity, cervical joint position sense, posture, cervical joint range of motion, strength and endurance of deep cervical flexor muscles, static and dynamic… Read more about this study

Who is it for?
Ages 30 to 55 years
Conditions the study is for
Chronic Neck Pain, Exercise Addiction
What is being tested?
Classical Physiotherapy Program + Cervical Stabilization Exercises, Classical Physiotherapy Program + Oculomotor Exercises and Classical Physiotherapy Program
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteCyprus
Study dates
1 Aug 2021to Jul 2022
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 30 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Men and women between the ages of 30-55,
  • Neck pain for at least 3 months,
  • Sedentary or non-regular exercise habit (3 days a week, less than 30 min of physical activity per day)
  • According to the Numerical Pain Scale, the pain intensity is 4 cm and above

Who cannot join

  • • Has received any physiotherapy program due to neck or back pain in the last 6 months,
  • Congenital anomaly in the cervical region (such as Klippel Feil Syndrome)
  • Having structural scoliosis at any level of the vertebral column,
  • Acute or chronic neurological deficits (sensory and motor loss),
  • With vertebrobasillary artery failure,
  • Thoracic Outlet Syndrome,
Show all 17Show fewer
  • Any vestibular problem,
  • With marked diplopia and oculomotor muscle insufficiency,
  • Having a cervical rib,
  • Having a history of fractures in the cervical vertebrae,
  • Colorblind,
  • Suffering from whiplash injury,
  • Those with serious rheumatic diseases such as Ankylosing Spondylitis, Rheumatoid Arthritis
  • Having undergone spine surgery from any region,
  • Tumor or spinal cord compression due to another reason,
  • Using any pain reliever drug other than simple analgesics.
  • Those who have problems related to the lumbar region such as lumbal stenosis, lumbar disc herniation

Trial locations and contacts

1 site in 1 country.

Cyprus1 site
  • Eastern Mediterranean University

    Famagusta, 99450

Other trials in Cyprus

About this study

Official title: Comparison the Effectiveness of Cervical Stabilization and Oculomotor Exercises in Addition to the Classical Physiotherapy on Pain Severity, Joint Position Sense and Physical Parameters in Individuals With Chronic Neck Pain

The aim of this study is to compare the effectiveness of Cervical Stabilization and Oculomotor Exercises in addition to the classical physiotherapy on pain severity, cervical joint position sense, posture, cervical joint range of motion, strength and endurance of deep cervical flexor muscles, static and dynamic balance, neck awareness, functional disability and patient satisfaction in individuals with chronic neck pain. When the literature is examined, there is no study comparing the effectiveness of cervical stabilization and oculomotor exercises in individuals with chronic neck pain. However, it has also attracted our attention that a progressive and dynamic program was not followed in studies stating the oculomotor exercise program. In this sense, The study is important in terms of both comparing the effects of these 3 treatments and presenting a progressive and dynamic exercise protocol to the literature.

Read the detailed description

The Participants included in the study will be divided into 3 groups. Participants in Group 1 will receive cervical stabilization exercises in addition to the classical physiotherapy program, individuals in Group 2 will receive oculomotor exercises in addition to the classical physiotherapy program, and only the classical physiotherapy program will be applied to group 3.

Transcutaneous Electrical Nerve Stimulation, hotpack, classical massage and stretching/posture exercises will be given to participants within the scope of the Classical Physiotherapy program. In addition to the classical physiotherapy program, the participants in the 1st and 2nd groups will be given exercises that gradually increase in difficulty level, 3 days a week, for a total of 8 weeks, under the control of a physiotherapist. Participants in the 3rd group will be given only classical physiotherapy. At the same time, stretching and posture exercises will be performed under the control of a physiotherapist.

Being tested
Classical Physiotherapy Program + Cervical Stabilization Exercises, Classical Physiotherapy Program + Oculomotor Exercises, Classical Physiotherapy Program
Keywords
Chronic Neck Pain, Proprioseption, Exercise, Stabilization, Oculomotor
Medical subject headings
Motor Activity

What participants receive

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

  • Classical Physiotherapy Program + Cervical Stabilization ExercisesOther

    Also called Cervical Stabilization

    First of all, patients will be taught correct craniocervical flexion movement without activation of superficial muscles in different positions (supine, prone, crawling, sitting, standing). The program will be continued by asking to maintain the cranio-cervical flexion position during all movements. In order to gain dynamic stabilization, unilateral, bilateral, contralateral, ipsilateral and reciprocal extremity movements will be added to the program together with craniocervical flexion movement. Resistance will be added to the exercises as control of the movement is achieved. The exercises will progress from static to dynamic, from stationary floors to moving floors, from simple movements to complex movements.

  • Classical Physiotherapy Program + Oculomotor ExercisesOther

    Also called Oculomotor Exercises

    Oculomotor Exercises is a program consisting of exercises that support proprioception in the cervical region. It consists of 4 main contents; Sacadic Eye movements, Gaze stability, Head/eye coordination, Head repositioning exercise.

  • Classical Physiotherapy ProgramOther

    Also called Classical Physiotherapy

    Conventional TENS will be applied to apply analgesic current. TENS application will be made to the cervical paravertebral region, using four 5 x 5 cm adhesive surface electrodes, at 80 Hz frequency for 20 minutes, 100 msec.

    All participants will be asked to lie in a prone position. The neck will be in a neutral position. The hot pack will be applied to the cervical region for 20 minutes.

    Classical massage will be applied for 20 minutes using the Swedish technique. The technique will be performed on the upper and neck region of the back with 3 strokes, 3 kneading and 3 strokes. The patient will be massaged while lying in the prone position.

    Stretching/Posture Exercises Exercises will be applied as a 5-10 minute warm-up-cool-down program at the beginning and end of the study. Cervical flexor, lateral flexor, rotator muscles, pectorals, inferior shoulder joint capsule will be stretched. In addition to this, posture exercises will also be done.

Study groups in NCT05083858
Study groupRoleWhat they receive
Classical Physiotherapy Program + Cervical Stabilization ExercisesExperimentalIn addition to classical physiotherapy, Cervical Stabilization Exercises will be applied to the individuals in the 1st group.
Receives: Other: Classical Physiotherapy Program + Cervical Stabilization Exercises
Classical Physiotherapy Program + Oculomotor ExercisesExperimentalIn addition to classical physiotherapy, Oculomotor Exercises will be applied to the individuals in the 2nd group.
Receives: Other: Classical Physiotherapy Program + Oculomotor Exercises
Classical Physiotherapy ProgramActive comparatorOnly the classical physiotherapy program will be applied to the individuals in 3rd group.
Receives: Other: Classical Physiotherapy Program

What is being measured

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

  1. Cervical Joint Position Sense

    Joint Position Sense of flexion-extension, right-left rotation and right-left lateral flexion movements of the cervical region will be evaluated. A laser marker will be used to perform the assessment. The target angle for cervical flexion, extension and right-left rotation joint position sense measurement is 30°, and 20° for right-left cervical lateral flexion. Measurements will be made with eyes open and eyes closed. Before the JPS evaluations, the method will be explained to the individuals in detail and a sufficient number of trials will be made before the tests. Considering that fatigue may affect the results, all individuals will be warned not to forcefully move their neck and back muscles before the measurement. In order to prevent proprioceptive input, they will be asked to come in comfortable clothes that do not wrap around the neck on the day of their evaluation.

    Measured: Change from Cervical Joint Position Sense at the end of 8 weeks

Secondary outcomes (10)
  1. Pain Intensity

    Numerical Pain Scale will be used to determine the severity of neck pain at rest and during activity.An increase in the score means an increase in the severity of the patient's neck pain.

    Measured: Change from Pain Intensity at the end of 8 weeks

  2. Craniovertebral Angle

    The posture of the cervical region will be evaluated by the lateral photographing method. Markers will be placed on specific anatomical points (C7, Tragus) and the lateral projections of these points will be used for angular calculations. The photos transferred to the computer will be transferred to the paint program and the lines connecting the markers will be drawn. Craniovertebral angle will be calculated using a computer program (Markus Bader-MB Software Solutions, Triangular Screen Ruler). Degree(°) is going to be record.

    Measured: Change from Craniovertebral Angle at the end of 8 weeks

  3. Cervical Joint Range of Motion

    Inclinometer (Baseline Bubble Inclinometer) will be used to evaluate the joint range of motion of the cervical region. Measurements of cervical flexion, extension and right-left lateral flexion will be made in sitting position, and right and left rotation measurements will be made in supine position.

    Measured: Change from Cervical Joint Range of Motion at the end of 8 weeks

  4. Strength and Endurance of the Deep Cervical Flexor Muscles

    Craniocervical flexion test (CCFT) is used to evaluate the activation and static endurance of the deep flexor muscles of the cervical region. The test will be performed using Stabilizer Pressure Biofeedback (Chattanooga Stabilizer). The patient will be positioned in the supine position, with the cervical region in neutral position and the biofeedback pressure unit will be placed in the suboccipital space. The pressure cell will be inflated to 20 mmHg. Then, the individual will be instructed to perform a posterior tilt movement by increasing the pressure at 5 different levels (22, 24, 26, 28 and 30 mmHg.), Following the monitor of the device. After teaching the movement, the person will be asked to perform 10 contractions lasting 10 seconds at each level. The person will move to the next level after each successful attempt.

    Measured: Change from Strength and Endurance of the Deep Cervical Flexor Muscles at the end of 8 weeks

  5. Static Balance

    Stork balance test will be used in the evaluation of static balance. While one side is standing on one foot, the individual places the other foot on the inside of the knee on which she/he is standing. She/he places his hands on the waist and, with the signal of the physiotherapist, raises the heel of the supporting leg from the ground. She/he tries to maintain this position as long as he can stand with his eyes open . After the trial, She/he will be told to take this position three times with his eyes open and the holding times will be recorded. The best score of the recorded times will be taken.

    Measured: Change from Static Balance at the end of 8 weeks

  6. Dynamic Balance

    It will be evaluated using the Y balance test. The reach distance in the anterior, posteromedial and posterolateral transport directions will be recorded. People will be asked to reach the furthest point with the other foot while trying to maintain balance with the dominant foot on the wooden platform while the hands are on the waist. 3 repetitions of reaching out in 3 directions will be recorded.

    Measured: Change from Dynamic Balance at the end of 8 weeks

  7. Neck Awareness

    The Fremantle Neck Awareness Questionnaire will be used to assess neck awareness. Fremantle Neck Awareness Questionnaire is a 9-item questionnaire that evaluates neck perception, attention and proprioceptive awareness of individuals with chronic neck pain. The first 3 questions of the questionnaire, which evaluates awareness in 4 dimensions, evaluate attention, the fourth and fifth questions evaluate proprioceptive perception, and the sixth, seventh and ninth questions evaluate how the neck is perceived as shape and size relative to its body. The eighth question was interpreted as 'negligence'. The questions of the Likert-type questionnaire are between 0 and 4 points, meaning 0=Never, 1=Rarely, 2=Sometimes, 3=Often, 4=Always. The total score is 36. A high score indicates decreased awareness of the neck.

    Measured: Change from Neck Awareness at the end of 8 weeks

  8. Functional Disability

    The Neck Disability Index (BDI) will be used to evaluate the functional disability of the neck. The questionnaire assesses how much neck pain associated with problems in the cervical region affects the individual in daily life and how much it interferes with the individual's daily work. The index consists of 10 items, 4 items evaluating subjective symptoms such as pain intensity, headache, concentration, sleep, and 6 items evaluating daily life activities such as personal care, lifting loads, reading, working life, driving, and leisure activities. Scoring is done between 0-5. The individual is asked to mark the answer that best fits him. If the total score obtained in the index is between 0-4, it is classified as no disability, between 5-14 as mild disability, between 15-24 as moderate disability, between 25-34 as severe disability and above 35 points as total disability.

    Measured: Change from Functional Disability at the end of 8 weeks

  9. Patient Satisfaction

    The Global Perceived Impact (GAE) questionnaire will be used to assess the extent to which individuals benefit from treatment after treatment. This questionnaire is used to evaluate the extent to which individuals benefit from treatment after treatment. Individuals are asked to rate between 1 (very much improved) and 9 (very much worsened) to the question 'How have your complaints changed compared to the time before your treatment?'. Scale scores were, in order, 1-very much improved, 2-very much improved, 3-moderately improved, 4-slightly improved, 5-unchanged, 6-slightly worsened, 7-moderately worsened, 8-very much worsened, 9-very much worsened. is in the form. Scoring will be done once at the end of the treatment.

    Measured: End of eight weeks

  10. Cervicothoracic angle

    The posture of the cervical region will be evaluated by the lateral photographing method. Markers will be placed on specific anatomical points (C7, Tragus and T4) and the lateral projections of these points will be used for angular calculations. The photos transferred to the computer will be transferred to the paint program and the lines connecting the markers will be drawn. Cervicothoracic angle will be calculated using a computer program (Markus Bader-MB Software Solutions, Triangular Screen Ruler). Degree(°) is going to be record.

    Measured: Change from Cervicothoracic angle at the end of 8 weeks

Timeline

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

  1. First posted19 Oct 2021
  2. Study start1 Aug 2021
  3. Primary completion25 Sep 2021
  4. Study completionJul 2022 (estimated)

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
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05083858
Sponsor's protocol ID
HU
Status last verified
Oct 2021
First submitted
27 Sep 2021
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jull GA, Falla D, Vicenzino B, Hodges PW. The effect of therapeutic exercise on activation of the deep cervical flexor muscles in people with chronic neck pain. Man Ther. 2009 Dec;14(6):696-701. doi: 10.1016/j.math.2009.05.004. Epub 2009 Jul 25.

    PubMed 19632880
  • Revel M, Minguet M, Gregoy P, Vaillant J, Manuel JL. Changes in cervicocephalic kinesthesia after a proprioceptive rehabilitation program in patients with neck pain: a randomized controlled study. Arch Phys Med Rehabil. 1994 Aug;75(8):895-9. doi: 10.1016/0003-9993(94)90115-5.

    PubMed 8053797
  • Jull G, Falla D, Treleaven J, Hodges P, Vicenzino B. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. 2007 Mar;25(3):404-12. doi: 10.1002/jor.20220.

    PubMed 17143898
  • Strimpakos N, Sakellari V, Gioftsos G, Kapreli E, Oldham J. Cervical joint position sense: an intra- and inter-examiner reliability study. Gait Posture. 2006 Jan;23(1):22-31. doi: 10.1016/j.gaitpost.2004.11.019.

    PubMed 16311191

Questions about this trial

What is this clinical trial studying?

A study testing Classical Physiotherapy Program + Cervical Stabilization Exercises, Classical Physiotherapy Program + Oculomotor Exercises and Classical Physiotherapy Program in people with Chronic Neck Pain and Exercise Addiction, run by Eastern Mediterranean University at 1 site in Cyprus.

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 17 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: status not confirmed, as of the sponsor's last update on 19 Oct 2021. 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 Cyprus. 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?

Results are not available in the source record.

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?

Cervical Joint Position Sense (time frame: Change from Cervical Joint Position Sense at the end of 8 weeks). 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 NCT05083858, which also lists 4 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 Oct 2021.

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