Correlation of Cervical Lordosis Degree Detected on Cervical X-Ray Image With Clinical, Demographic and MRI Findings

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.

Study Overview

• Status: Recruiting
• Conditions: Neck Pain; Disk, Herniated; Cervical Lordosis
• Intervention / Treatment: Other: CHRONIC NECK PAIN

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 Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Haydarpasa Numune Education and Research Hospital
    • Contact: Duygu Külcü, Prof.; Phone Number: 00905058575178; Email: d_geler@yahoo.com.tr
    • Contact: Ozlem Kaleoglu, MD; Phone Number: 00905321598018; Email: ozlemkaleoglu@gmail.com
    • Sub-Investigator: Özlem Kaleoğlu, MD
    • Sub-Investigator: Dilara Dilik, MD
    • Sub-Investigator: Elem Yorulmaz, MD
    • Sub-Investigator: Nilgün Mesci, Ass Prof.
    • Sub-Investigator: Elif Çiğdem Altunok, Ass Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: CHRONIC NECK PAIN; Demographic information will be collected. Neck Disability Index will be filled. Physical examination will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C2-C7 COBB ANGLE	MEASURING C2-C7 COBB ANGLE ON LATERAL CERVICAL X-RAY IMAGE	1 week
C2-C7 POSTERIOR TANJANT ANGLE	MEASURING C2-C7 POSTERIOR TANJANT ANGLE ON LATERAL CERVICAL X-RAY IMAGE	1 week
C2-C7 CERVICAL VERTEBRAL ALIGNMENT (CVA)	C2-C7 CERVICAL VERTEBRAL ALIGNMENT ON LATERAL CERVIKAL X-RAY IMAGE	1 week
CERVICAL HERNIATION LEVEL	CERVICAL HERNIATION LEVEL ON CERVICAL MRI	1 week
CERVICAL HERNIATION DEGREE	CERVICAL HERNIATION DEGREE ON CERVICAL MRI: BULGING,PROTRUSION, SECESTRATION, EXTRUDATION	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DEMOGRAPHIC FINDINGS	AGE	1 week
SCREEN TIME	AVARAGE TIME SPENT ON TV, COMPUTER AND MOBILE PHONE DURING A DAY IN HOURS	1 week
VISUAL ANALOG SCALE (VAS)	VISUAL ANALOG SCALE SCORE FOR THE NECK PAIN FROM 1-10	1 week
NECK DISABILITY INDEX (NDI)	NECK DISABILITY INDEX SCORE	1 week
DURATION OF THE NECK PAIN	HOW LONG DOES THE PATIENT FEELS THE NECK PAIN IN MONTHS	1 week

Collaborators and Investigators

• Sponsor: Haydarpasa Numune Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2021
• Primary Completion (Anticipated): July 5, 2021
• Study Completion (Anticipated): July 10, 2021

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: neck pain; trigger points; cervical sagittal balance; flex head posture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nutrition Disorders; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Deficiency Diseases; Malnutrition; Spinal Diseases; Bone Diseases; Spinal Curvatures; Hernia; Intervertebral Disc Displacement; Neck Pain; Lordosis; Swayback
• Other Study ID Numbers: HNEAH-KAEK 2021/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No