Neck PainNCT04886661
Correlation of Cervical Lordosis Degree Detected on Cervical X-Ray Image With Clinical, Demographic and MRI Findings
An observational study of Neck Pain and Cervical Lordosis, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study we are investigating whether there is a relationship between the lordosis angle measured on cervical X-RAY images on the severity and level of cervical disc herniation detected by cervical MRI, demographic characteristics and the duration and posture of the person's daily life activities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Cervical Lordosis, Disk, Herniated
- What is being tested?
- CHRONIC NECK PAIN
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2021to 10 Jul 2021
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 125 Patients with chronic neck pain aged between 18-65 who have their Cervical X-RAY and MRIs being taken within the last 3 months in regards to the inclusion and exclusion criterias.
Who may be able to join
- 18-65 years old
- Axial neck pain and / or upper extremity radicular symptoms
- Existing MR and X-Ray radiographs taken within the last 3 months for cervical disc pathologies
Who cannot join
- A history of trauma,
- Patients with rheumatoid / autoimmune diseases such as rheumatoid arthritis or ankylosing spondylitis,
- A history of Cervical fracture or cervical spine surgery
- History of cancer history, neurological disease
- Muscle weakness
- Presence of Scoliosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Haydarpaşa Numune Education and Research Hospital
Istanbul
Duygu Külcü, Prof., 00905058575178, d_geler@yahoo.com.tr
Ozlem Kaleoglu, MD, 00905321598018, ozlemkaleoglu@gmail.com
About this study
Official title: Correlation of Cervical Lordosis Detected on Cervical X-Ray Images With Clinical, Demographic and MRI Findings
In this study we are investigating whether there is a relationship between the lordosis angle measured on cervical X-RAY images on the severity and level of cervical disc herniation detected by cervical MRI, demographic characteristics and the duration and posture of the person's daily life activities.
Read the detailed description
At least 125 patients between the ages of 18-65 who meet the inclusion criteria with cervical cervical X-RAY and cervical MRIs taken in the last 3 months will be included in the study.
The demographic characteristics of the patients such as age, gender, BMI, job, education level, marital status, as well as the time they spend on head flexion posture, and their screen time will be questioned. The presence of active trigger points in the cervical muscles will be determined by examination (levator scapula, trapeze, longus colli, splenius capitis).
Neck Disability Index will be filled in order to evaluate activities of daily life. Symptom duration and pain level will be evaluated by VAS.
Tangent and Cobb angles will be measured on cervical X-RAY images. Presence of effective lordosis will be recorded.
In cervical MR, disc herniation level, number, degree (bulging, protrusion, extruded disc) its level will be recorded.
- Conditions
- Neck Pain, Cervical Lordosis, Disk, Herniated
- Being tested
- CHRONIC NECK PAIN
- Keywords
- neck pain, cervical sagittal balance, trigger points, flex head posture
- Medical subject headings
- Neck Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHRONIC NECK PAINOther
Demographic information will be collected. Neck Disability Index will be filled. Physical examination will be performed.
| Study group | Role | What they receive |
|---|---|---|
| PATIENTS WITH CHRONIC NECK PAIN | Patients between the ages of 18-65 who are eligible for the inclusion criteria will be included in the study who have cervical X-RAY and cervical MRIs taken in the last 3 months. Receives: Other: CHRONIC NECK PAIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
C2-C7 COBB ANGLE
MEASURING C2-C7 COBB ANGLE ON LATERAL CERVICAL X-RAY IMAGE
Measured: 1 week
C2-C7 POSTERIOR TANJANT ANGLE
MEASURING C2-C7 POSTERIOR TANJANT ANGLE ON LATERAL CERVICAL X-RAY IMAGE
Measured: 1 week
C2-C7 CERVICAL VERTEBRAL ALIGNMENT (CVA)
C2-C7 CERVICAL VERTEBRAL ALIGNMENT ON LATERAL CERVIKAL X-RAY IMAGE
Measured: 1 week
CERVICAL HERNIATION LEVEL
CERVICAL HERNIATION LEVEL ON CERVICAL MRI
Measured: 1 week
CERVICAL HERNIATION DEGREE
CERVICAL HERNIATION DEGREE ON CERVICAL MRI: BULGING,PROTRUSION, SECESTRATION, EXTRUDATION
Measured: 1 week
Secondary outcomes (5)
DEMOGRAPHIC FINDINGS
AGE
Measured: 1 week
SCREEN TIME
AVARAGE TIME SPENT ON TV, COMPUTER AND MOBILE PHONE DURING A DAY IN HOURS
Measured: 1 week
VISUAL ANALOG SCALE (VAS)
VISUAL ANALOG SCALE SCORE FOR THE NECK PAIN FROM 1-10
Measured: 1 week
NECK DISABILITY INDEX (NDI)
NECK DISABILITY INDEX SCORE
Measured: 1 week
DURATION OF THE NECK PAIN
HOW LONG DOES THE PATIENT FEELS THE NECK PAIN IN MONTHS
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start5 Jun 2021
- Primary completion5 Jul 2021 (estimated)
- Study completion10 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Geler Külcü, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886661
- Sponsor's protocol ID
- HNEAH-KAEK 2021/22
- Status last verified
- Jun 2021
- First submitted
- 5 May 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Cervical Lordosis Detected on Cervical X-Ray Images With Clinical, Demographic and MRI Findings
- ClinicalTrials.gov ID
- NCT04886661
- Acronym / sponsor ID
- HNEAH-KAEK 2021/22
- Conditions
- Neck Pain, Cervical Lordosis, Disk, Herniated
- Keywords
- neck pain, cervical sagittal balance, trigger points, flex head posture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 5 Jul 2021 (estimated)
- Study completion
- 10 Jul 2021 (estimated)
- First posted
- 14 May 2021 (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.
In this study we are investigating whether there is a relationship between the lordosis angle measured on cervical X-RAY images on the severity and level of cervical disc herniation detected by cervical MRI, demographic characteristics and the duration and posture of the person's daily life activities.
Detailed description
At least 125 patients between the ages of 18-65 who meet the inclusion criteria with cervical cervical X-RAY and cervical MRIs taken in the last 3 months will be included in the study.
The demographic characteristics of the patients such as age, gender, BMI, job, education level, marital status, as well as the time they spend on head flexion posture, and their screen time will be questioned. The presence of active trigger points in the cervical muscles will be determined by examination (levator scapula, trapeze, longus colli, splenius capitis).
Neck Disability Index will be filled in order to evaluate activities of daily life. Symptom duration and pain level will be evaluated by VAS.
Tangent and Cobb angles will be measured on cervical X-RAY images. Presence of effective lordosis will be recorded.
In cervical MR, disc herniation level, number, degree (bulging, protrusion, extruded disc) its level will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PATIENTS WITH CHRONIC NECK PAIN | – | Other: CHRONIC NECK PAINPatients between the ages of 18-65 who are eligible for the inclusion criteria will be included in the study who have cervical X-RAY and cervical MRIs taken in the last 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 125 Patients with chronic neck pain aged between 18-65 who have their Cervical X-RAY and MRIs being taken within the last 3 months in regards to the inclusion and exclusion criterias.
Key inclusion criteria (3 listed)
- 18-65 years old
- Axial neck pain and / or upper extremity radicular symptoms
- Existing MR and X-Ray radiographs taken within the last 3 months for cervical disc pathologies
Key exclusion criteria (6 listed)
- A history of trauma,
- Patients with rheumatoid / autoimmune diseases such as rheumatoid arthritis or ankylosing spondylitis,
- A history of Cervical fracture or cervical spine surgery
- History of cancer history, neurological disease
- Muscle weakness
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 |
|---|---|---|
| CHRONIC NECK PAINDemographic information will be collected. Neck Disability Index will be filled. Physical examination will be performed. | Other | PATIENTS WITH CHRONIC NECK PAIN |
Primary outcome
C2-C7 COBB ANGLE
Time frame: 1 week
MEASURING C2-C7 COBB ANGLE ON LATERAL CERVICAL X-RAY IMAGE
C2-C7 POSTERIOR TANJANT ANGLE
Time frame: 1 week
MEASURING C2-C7 POSTERIOR TANJANT ANGLE ON LATERAL CERVICAL X-RAY IMAGE
C2-C7 CERVICAL VERTEBRAL ALIGNMENT (CVA)
Time frame: 1 week
C2-C7 CERVICAL VERTEBRAL ALIGNMENT ON LATERAL CERVIKAL X-RAY IMAGE
CERVICAL HERNIATION LEVEL
Time frame: 1 week
CERVICAL HERNIATION LEVEL ON CERVICAL MRI
CERVICAL HERNIATION DEGREE
Time frame: 1 week
CERVICAL HERNIATION DEGREE ON CERVICAL MRI: BULGING,PROTRUSION, SECESTRATION, EXTRUDATION
5 secondary outcomes
DEMOGRAPHIC FINDINGS
Time frame: 1 week
SCREEN TIME
Time frame: 1 week
VISUAL ANALOG SCALE (VAS)
Time frame: 1 week
NECK DISABILITY INDEX (NDI)
Time frame: 1 week
DURATION OF THE NECK PAIN
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Haydarpaşa Numune Education and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Cervical Lordosis, run by Haydarpasa Numune Training and Research Hospital 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 6 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 29 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C2-C7 COBB ANGLE (time frame: 1 week). The study lists 5 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 29 Jun 2021.