NCT04886661

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

June 5, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

May 5, 2021

Last Update Submit

June 26, 2021

Conditions

Keywords

neck paincervical sagittal balancetrigger pointsflex head posture

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • DEMOGRAPHIC FINDINGS

    1 week

  • SCREEN TIME

    1 week

  • VISUAL ANALOG SCALE (VAS)

    1 week

  • NECK DISABILITY INDEX (NDI)

    1 week

  • DURATION OF THE NECK PAIN

    1 week

Study Arms (1)

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

Interventions

Demographic information will be collected. Neck Disability Index will be filled. Physical examination will be performed.

PATIENTS WITH CHRONIC NECK PAIN

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydarpaşa Numune Education and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck PainIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, M.D.

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 14, 2021

Study Start

June 5, 2021

Primary Completion

July 5, 2021

Study Completion

July 10, 2021

Last Updated

June 29, 2021

Record last verified: 2021-06

Locations