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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04886661
Other study ID # HNEAH-KAEK 2021/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 5, 2021
Est. completion date July 10, 2021

Study information

Verified date June 2021
Source Haydarpasa Numune Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 125
Est. completion date July 10, 2021
Est. primary completion date July 5, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Other:
CHRONIC NECK PAIN
Demographic information will be collected. Neck Disability Index will be filled. Physical examination will be performed.

Locations

Country Name City State
Turkey Haydarpasa Numune Education and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary C2-C7 COBB ANGLE MEASURING C2-C7 COBB ANGLE ON LATERAL CERVICAL X-RAY IMAGE 1 week
Primary C2-C7 POSTERIOR TANJANT ANGLE MEASURING C2-C7 POSTERIOR TANJANT ANGLE ON LATERAL CERVICAL X-RAY IMAGE 1 week
Primary C2-C7 CERVICAL VERTEBRAL ALIGNMENT (CVA) C2-C7 CERVICAL VERTEBRAL ALIGNMENT ON LATERAL CERVIKAL X-RAY IMAGE 1 week
Primary CERVICAL HERNIATION LEVEL CERVICAL HERNIATION LEVEL ON CERVICAL MRI 1 week
Primary CERVICAL HERNIATION DEGREE CERVICAL HERNIATION DEGREE ON CERVICAL MRI: BULGING,PROTRUSION, SECESTRATION, EXTRUDATION 1 week
Secondary DEMOGRAPHIC FINDINGS AGE 1 week
Secondary SCREEN TIME AVARAGE TIME SPENT ON TV, COMPUTER AND MOBILE PHONE DURING A DAY IN HOURS 1 week
Secondary VISUAL ANALOG SCALE (VAS) VISUAL ANALOG SCALE SCORE FOR THE NECK PAIN FROM 1-10 1 week
Secondary NECK DISABILITY INDEX (NDI) NECK DISABILITY INDEX SCORE 1 week
Secondary DURATION OF THE NECK PAIN HOW LONG DOES THE PATIENT FEELS THE NECK PAIN IN MONTHS 1 week
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