Neck PainNCT02424058
The Investigation of Thoracic Spinal Curvature and Mobility in Subjects With and Without Neck Pain: Cut-off Points
An observational study of Neck Pain, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Spinal Mouse® measurement and Neck pain intensity measurement
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Chronic neck pain and heatlhy subjects
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk Training and Research Hospital
Ankara, Cankaya, 06800
Seyda - TOPRAK CELENAY, Assist. Prof, +90 530 041 39 86, sydtoprak@hotmail.com
Derya - OZER KAYA, Assoc. Prof, +90 232 329 35 13 ext. 4711, deryaozer2000@yahoo.com
About this study
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
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
- Conditions
- Neck Pain
- Being tested
- Spinal Mouse® measurement, Neck pain intensity measurement
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Mouse® measurementDevice
The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.
Neck pain intensity measurementBehavioural
The neck pain intensity of the patients was questioned by Visual Analogue Scale
| Study group | Role | What they receive |
|---|---|---|
| Neck pain | Patients aged between 18 and 65 years with persistent neck pain for more than 3 months Receives: Device: Spinal Mouse® measurement; Behavioral: 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 Receives: Device: Spinal Mouse® measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic curvature, as measured by Spinal Mouse®
Measured: 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
Measured: participants will be followed for the duration of hospital stay, an expected average of one year
Thoracic mobility, as measured by Spinal Mouse®
Measured: participants will be followed for the duration of hospital stay, an expected average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424058
- Sponsor's protocol ID
- 2015-56/32
- Status last verified
- Apr 2015
- First submitted
- 12 Apr 2015
- Last updated
- 22 Apr 2015
- Results posted
- No
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.
PubMed 20430685Nejati 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.
PubMed 25250268Tsunoda 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.
PubMed 23232803
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02424058
- Acronym / sponsor ID
- 2015-56/32
- Conditions
- Neck Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck pain | – | Device: Spinal Mouse® measurement, Behavioral: Neck pain intensity measurementPatients aged between 18 and 65 years with persistent neck pain for more than 3 months |
| Healthy | – | Device: Spinal Mouse® measurementAcceptance to participate in the study, no previous neck oain (lifetime-to-date), no spinal surgery or deformity, and no radiological abnormalities detected |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic neck pain and heatlhy subjects
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Mouse® measurementThe sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position. | Device | Healthy, Neck pain |
| Neck pain intensity measurementThe neck pain intensity of the patients was questioned by Visual Analogue Scale | Behavioural | Neck pain |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Results publication: PubMed 20430685Lau 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.
- Results publication: PubMed 25250268Nejati 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.
- Results publication: PubMed 23232803Tsunoda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda - TOPRAK CELENAY, Assist.Prof (+90 530 041 3986, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02424058, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.