HealthyNCT03856008
Effect of Cervical Spinal Stabilization Exercise Programs by Magnetic Resonance Imaging in Healthy Individuals
A study testing Exercises focused on flexor muscles and Exercises focused on extensor muscles in people with Healthy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercises focused on flexor muscles and Exercises focused on extensor muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2019to 17 Jun 2019
- 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
- being healthy
- age between 18 to 30 years
- agree to participate in the study
Who cannot join
- 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
Show all 10Show fewer
- radiculopathy
- myelopathy
- other neurological disorders
- vestibular disorders and/or trauma history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Sıhhıye, 06430
About this study
Official title: Investigation of Morphological Changes of Cervical Spinal Stabilization Exercise Programs Focused on Flexor and Extensor Muscles in Cervical Muscles by Magnetic Resonance Imaging in Healthy Individuals
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.
- Conditions
- Healthy
- Being tested
- Exercises focused on flexor muscles, Exercises focused on extensor muscles
- Keywords
- cervical spinal stabilisation exercises, muscle cross sectional area, muscle t2 relaxation time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises focused on flexor musclesOther
Exercises emphasis flexor muscles.
Exercises focused on extensor musclesOther
Exercises emphasis extensor muscles.
| Study group | Role | What they receive |
|---|---|---|
| Exercises focused on flexor muscles. | Experimental | Flexor cervical stabilization exercises will be applied. Receives: Other: Exercises focused on flexor muscles |
| Exercises focused on extensor muscles. | Experimental | Extensor cervical stabilization exercises will be applied. Receives: Other: Exercises focused on extensor muscles |
| Control. | No intervention | No intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline time at the end of 8 week
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.
Measured: change from baseline time at the end of 8 week
Secondary outcomes (6)
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.
Measured: change from baseline score at the end of 8 week
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.
Measured: change from baseline score at the end of 8 week
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.
Measured: change from baseline score at the end of 8 week
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.
Measured: change from baseline score at the end of 8 week
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.
Measured: change from baseline score at the end of 8 week
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.
Measured: change from baseline score at the end of 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start25 Feb 2019
- Primary completion2 May 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdi Kayabınar, Hacettepe University
- Investigators
- Erdi Kayabınar, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856008
- Sponsor's protocol ID
- KA-180136
- Status last verified
- Jun 2019
- First submitted
- 25 Feb 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Morphological Changes of Cervical Spinal Stabilization Exercise Programs Focused on Flexor and Extensor Muscles in Cervical Muscles by Magnetic Resonance Imaging in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03856008
- Acronym / sponsor ID
- KA-180136
- Conditions
- Healthy
- Keywords
- cervical spinal stabilisation exercises, muscle cross sectional area, muscle t2 relaxation time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 27 Feb 2019 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercises focused on flexor muscles. | Experimental | Other: Exercises focused on flexor musclesFlexor cervical stabilization exercises will be applied. |
| Exercises focused on extensor muscles. | Experimental | Other: Exercises focused on extensor musclesExtensor cervical stabilization exercises will be applied. |
| Control. | No intervention | –No intervention will be applied. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being healthy
- age between 18 to 30 years
- agree to participate in the study
Key exclusion criteria (10 listed)
- to undergo any surgical procedure of the vertebral column
- inflammatory disease
- rheumatological disease
- history of malignancy
- congenital spinal cord anomaly
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 |
|---|---|---|
| Exercises focused on flexor musclesExercises emphasis flexor muscles. | Other | Exercises focused on flexor muscles. |
| Exercises focused on extensor musclesExercises emphasis extensor muscles. | Other | Exercises focused on extensor muscles. |
Primary outcome
Cervical muscles cross sectional area
Time frame: Change from baseline time at the end of 8 week
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.
Cervical muscle T2 relaxation time
Time frame: change from baseline time at the end of 8 week
T2 relaxation time of circled muscles will be measured with milliseconds. T2 axial and t2 mapping images will be obtained with mri.
6 secondary outcomes
Cervical muscle strength
Time frame: change from baseline score at the end of 8 week
New York posture rating chart
Time frame: change from baseline score at the end of 8 week
Tragus angle measurement
Time frame: change from baseline score at the end of 8 week
Cervical flexor and extensor endurance test
Time frame: change from baseline score at the end of 8 week
Cervical range of motion measurement
Time frame: change from baseline score at the end of 8 week
Evaluation of cervical spine curvature
Time frame: change from baseline score at the end of 8 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 18 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Erdi Kayabınar, MSc principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises focused on flexor muscles and Exercises focused on extensor muscles in people with Healthy, run by Hacettepe 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 3 inclusion and 10 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 18 Jun 2019. 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?
Cervical muscles cross sectional area (time frame: Change from baseline time at the end of 8 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2019.