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CompletedNCT03856008Updated Jun 18, 2019

Effect of Cervical Spinal Stabilization Exercise Programs by Magnetic Resonance Imaging in Healthy Individuals

An interventional study of Exercises focused on flexor muscles and Exercises focused on extensor muscles in Healthy, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-18.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study summary

The aim of this study was to investigate the morphological changes in the neck muscles of cervical spinal stabilization exercises focused on flexor and extensor muscles applied to healthy individuals.

Read the detailed description

In the prevention and treatment of cervical region pathologies, various exercise methods are applied in the clinic. The clinical exercises vary according to the time and severity of the pathology but also according to the pathology itself. These exercises include exercises focusing on flexor or extensor muscles. The aim of this study was to investigate the morphological changes in the neck muscles of cervical spinal stabilization exercises focused on flexor and extensor muscles applied to healthy individuals. At least 27 healthy male subjects between the age of 18-30 are planned to be included in the study. Individuals will be divided into 3 groups by simple randomization method. In one group cervical stabilization exercise program focused on the flexor muscles will be applied and the other group cervical stabilization exercise program focused on the extensor muscles will be applied for 8 weeks. Individuals in the control group will only be evaluated without exercise. In the study, by using magnetic resonance imaging (MRI) method as the main evaluation, muscle anatomical cross-sectional area and T2 relaxation time measurements will be made and morphological changes in muscles will be determined. These evaluation procedures will be performed on longus colli, sternocleidomastoid, semispinalis cervicis, multifidus and upper trapezius muscles. As additional evaluation methods, muscle strength and muscle endurance tests, normal joint motion measurements, posture evaluation and MRI measurement of cervical spine curvature will be performed. All evaluations will be performed at the beginning and at the end of these 8 weeks and the effects of the exercises applied on the muscles in the two groups will be examined.

02

Conditions studied

  • Healthy

Keywords

  • cervical spinal stabilisation exercises
  • muscle cross sectional area
  • muscle t2 relaxation time
03

In context

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • being healthy
  • age between 18 to 30 years
  • agree to participate in the study

Exclusion criteria

Exclusion Criteria:

  • to undergo any surgical procedure of the vertebral column
  • inflammatory disease
  • rheumatological disease
  • history of malignancy
  • congenital spinal cord anomaly
  • congenital and/or spinal deformities
  • radiculopathy
  • myelopathy
  • other neurological disorders
  • vestibular disorders and/or trauma history
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Exercises focused on flexor muscles.

    Flexor cervical stabilization exercises will be applied.

    Other: Exercises focused on flexor muscles

  • Experimental
    Exercises focused on extensor muscles.

    Extensor cervical stabilization exercises will be applied.

    Other: Exercises focused on extensor muscles

  • No intervention
    Control.

    No intervention will be applied.

Interventions

  • OtherExercises focused on flexor muscles

    Exercises emphasis flexor muscles.

  • OtherExercises focused on extensor muscles

    Exercises emphasis extensor muscles.

06

What researchers measure

Primary outcomes

  1. Cervical muscles cross sectional area

    Measurement of the cross-sectional area of the examined muscles by axial mri images. The circles of the muscles will be drawn by hand and examined with a computer program.

    Time frame: Change from baseline time at the end of 8 week

  2. Cervical muscle T2 relaxation time

    T2 relaxation time of circled muscles will be measured with milliseconds. T2 axial and t2 mapping images will be obtained with mri.

    Time frame: change from baseline time at the end of 8 week

Secondary outcomes

  1. Cervical muscle strength

    The strength of the cervical flexor and extensor muscles and deltoid muscles will be measured by a digital hand dynamometer (Lafayette Instrument Company, USA). The measurements of the dynamometer will be based on fine muscle test positions described by Lovett. When measuring the muscle strength, resistance will be given from the frontal region for flexors and over the occipital region for the cervical extensors. Resistance for deltoid muscles will be given around the shoulder. The tests will be repeated three times and the highest of 3 repeated results obtained from these measurements will be recorded. The strength of the muscles around the scapula will be evaluated with manual muscle test, which is rated at 0-5 points developed by Lovett. 5 point is maximum and 0 is the minimum point. Statistical analyzes will be done with total muscle strength values. A total of eight muscle muscle tests will be performed to evaluate the scapular muscles.

    Time frame: change from baseline score at the end of 8 week

  2. New York posture rating chart

    This evaluation system is scored by monitoring the posture changes that may occur in 13 different parts of the body. Accordingly, if the person's posture is correct five points will be given.If impairment is moderate, three points will be given and if the impairment is severe, 0 point will be given.

    Time frame: change from baseline score at the end of 8 week

  3. Tragus angle measurement

    The evaluation of the tragus angle will be used as a result of the evaluation of the photograph taken in front of the checkered back surface with the computer program. The Tragus, ear and C7 vertebrae will be marked and measured.

    Time frame: change from baseline score at the end of 8 week

  4. Cervical flexor and extensor endurance test

    The endurance evaluation of the deep cervical flexor muscles patients will be lied in the supine position, while the hands are in the free position on the abdomen, and the patient will be asked to remove the head slightly with the instruction. A slight amount (30%) craniocervical flexion will be required after this position has been taught to the patient. The time in which the patient maintains the position while maintaining the craniocervical flexion will be recorded in seconds. In the evaluation of endurance of deep cervical extensor muscles, the individual will be asked to lie down from T6 level and the head and neck will droop from the bed. The person will be instructed to bear the weight (4 kg in men) attached to a velcro placed over the ears in this position. The test will begin with a slight amount of craniocervical flexion, as if the individual makes head up against weight, and the time the individual maintains this position will be measured in seconds.

    Time frame: change from baseline score at the end of 8 week

  5. Cervical range of motion measurement

    The Cervical Range of Motion (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3) device will be used for the active evaluation of cervical range of motion. Flexion-extension, rotation and lateral flexion measurements will be performed at appropriate positions. The value found on the compass of the device will be recorded after each measurement.

    Time frame: change from baseline score at the end of 8 week

  6. Evaluation of cervical spine curvature

    In the evaluation of cervical spine curvature, measurements of Cobb angle will be used on images taken in sagittal plane with MRI.

    Time frame: change from baseline score at the end of 8 week

07

Study locations

1 site
  • Hacettepe University Faculty of Physical Therapy and Rehabilitation
    Ankara, Sıhhıye 06430, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03856008
Lead sponsor
Hacettepe University
Responsible party
Erdi Kayabınar (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Feb 27, 2019
Start date
Feb 25, 2019
Primary completion
May 2, 2019
Completion
Jun 17, 2019
Last update
Jun 18, 2019

Study contacts

Erdi Kayabınar, MSc
principal investigator · Hacettepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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