The Investigation of Thoracic Spinal Curvature and Mobility in Subjects With and Without Neck Pain: Cut-off Points

Neck Pain Clinical Trial

Official title:

The Investigation of the Sagittal Thoracic Spinal Curvature and Mobility in Subjects With and Without Chronic Neck Pain: Cut-off Points and Pain Relationship

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02424058
• Other study ID #: 2015-56/32
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2015
• Last updated: April 18, 2015
• Start date: July 2014

Study information

• Verified date: April 2015
• Source: Ataturk Training and Research Hospital
• Contact: Seyda - TOPRAK CELENAY, Assist.Prof
• Phone: +90 530 041 3986
• Email: sydtoprak[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

• The inclusion criteria for the control group included acceptance to participate in the study, no previous neck pain (lifetime-to-date), no spinal surgery or deformity, and no radiological abnormalities detected

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Neck Pain
• Spinal Curvatures

Intervention

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

Behavioral:
• Neck pain intensity measurement
The neck pain intensity of the patients was questioned by Visual Analogue Scale

Locations

Country	Name	City	State
Turkey	Ataturk Training and Research Hospital	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thoracic curvature, as measured by Spinal Mouse®		participants will be followed for the duration of hospital stay, an expected average of one year	Yes
Secondary	Pain, as measured by Visual Analog Scale		participants will be followed for the duration of hospital stay, an expected average of one year	Yes
Secondary	Thoracic mobility, as measured by Spinal Mouse®		participants will be followed for the duration of hospital stay, an expected average of one year	Yes