NCT02424058

Brief Summary

The purpose of this study is to investigate the sagittal thoracic spinal curvature and mobility in subjects with and without chronic neck pain, cut-off points and pain relationship

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 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

Study Start

First participant enrolled

July 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

April 12, 2015

Last Update Submit

April 18, 2015

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Thoracic curvature, as measured by Spinal Mouse®

    participants will be followed for the duration of hospital stay, an expected average of one year

Secondary Outcomes (2)

  • Pain, as measured by Visual Analog Scale

    participants will be followed for the duration of hospital stay, an expected average of one year

  • Thoracic mobility, as measured by Spinal Mouse®

    participants will be followed for the duration of hospital stay, an expected average of one year

Study Arms (2)

Neck pain

Patients aged between 18 and 65 years with persistent neck pain for more than 3 months

Device: Spinal Mouse® measurementBehavioral: Neck pain intensity measurement

Healthy

Acceptance to participate in the study, no previous neck oain (lifetime-to-date), no spinal surgery or deformity, and no radiological abnormalities detected

Device: Spinal Mouse® measurement

Interventions

Spinal Mouse® measurementDEVICE

The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.

HealthyNeck pain
Neck pain intensity measurementBEHAVIORAL

The neck pain intensity of the patients was questioned by Visual Analogue Scale

Neck pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Chronic neck pain and heatlhy subjects

You may qualify if:

  • Patients aged between 18 and 65 years with persistent neck pain for more than 3 months

You may not qualify if:

  • Prior history of injury or surgery relating to spine, spinal deformity, neurological symptoms or signs, radiological abnormalities indicating cervical radiculopathy or myelopathy, prior history of other spinal disorder such as low back pain, active intervention in the last 3 months including drug therapy or physiotherapy, malignancy, systemic pathology including any rheumatologic disease and osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk Training and Research Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Lau KT, Cheung KY, Chan KB, Chan MH, Lo KY, Chiu TT. Relationships between sagittal postures of thoracic and cervical spine, presence of neck pain, neck pain severity and disability. Man Ther. 2010 Oct;15(5):457-62. doi: 10.1016/j.math.2010.03.009.

    PMID: 20430685RESULT

  • Nejati P, Lotfian S, Moezy A, Moezy A, Nejati M. The relationship of forward head posture and rounded shoulders with neck pain in Iranian office workers. Med J Islam Repub Iran. 2014 May 3;28:26. eCollection 2014.

    PMID: 25250268RESULT

  • Tsunoda D, Iizuka Y, Iizuka H, Nishinome M, Kobayashi R, Ara T, Yamamoto A, Takagishi K. Associations between neck and shoulder pain (called katakori in Japanese) and sagittal spinal alignment parameters among the general population. J Orthop Sci. 2013 Mar;18(2):216-9. doi: 10.1007/s00776-012-0341-6. Epub 2012 Dec 12.

    PMID: 23232803RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Seyda - TOPRAK CELENAY, Assist.Prof

CONTACT

+90 530 041 3986sydtoprak@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PT, PhD

Study Record Dates

First Submitted

April 12, 2015

First Posted

April 22, 2015

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

TU(1)