- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02424058
The Investigation of Thoracic Spinal Curvature and Mobility in Subjects With and Without Neck Pain: Cut-off Points
April 18, 2015 updated by: Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
The Investigation of the Sagittal Thoracic Spinal Curvature and Mobility in Subjects With and Without Chronic Neck Pain: Cut-off Points and Pain Relationship
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Cankaya
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Ankara, Cankaya, Turkey, 06800
- Recruiting
- Ataturk Training and Research Hospital
-
Contact:
- Seyda - TOPRAK CELENAY, Assist. Prof
- Phone Number: +90 530 041 39 86
- Email: sydtoprak@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with Chronic neck pain and heatlhy subjects
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neck pain
Patients aged between 18 and 65 years with persistent neck pain for more than 3 months
|
The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.
The neck pain intensity of the patients was questioned by Visual Analogue Scale
|
Healthy
Acceptance to participate in the study, no previous neck oain (lifetime-to-date), no spinal surgery or deformity, and no radiological abnormalities detected
|
The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Thoracic curvature, as measured by Spinal Mouse®
Time Frame: participants will be followed for the duration of hospital stay, an expected average of one year
|
participants will be followed for the duration of hospital stay, an expected average of one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain, as measured by Visual Analog Scale
Time Frame: participants will be followed for the duration of hospital stay, an expected average of one year
|
participants will be followed for the duration of hospital stay, an expected average of one year
|
Thoracic mobility, as measured by Spinal Mouse®
Time Frame: participants will be followed for the duration of hospital stay, an expected average of one year
|
participants will be followed for the duration of hospital stay, an expected average of one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Anticipated)
July 1, 2015
Study Registration Dates
First Submitted
April 12, 2015
First Submitted That Met QC Criteria
April 18, 2015
First Posted (Estimate)
April 22, 2015
Study Record Updates
Last Update Posted (Estimate)
April 22, 2015
Last Update Submitted That Met QC Criteria
April 18, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-56/32
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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