Neck Painneck painNCT06884137
Investigation of the Relationship Between Neck Pain and Spinal Curvatures
An observational study of Neck Pain, run by Kirsehir Ahi Evran Universitesi.
Trial summary
Although it is known that the cervical, thoracic and lumbar regions of the spine are related with each other biomechanically, there are no studies examining the relationship between cervical pain and other regions of the spine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2013to 11 Jun 2013
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who were referred to the physiotherapy program by a specialist physician (SS) and met the inclusion criteria were included in the study. Inclusion criteria were as follows: being 18-65 years old, presence of neck pain for at least 3 months, absence of any other problems related to other parts of the spine such as low back pain, absence of any neurological, rheumatical or musculoskeletal problems. Exclusion criteria were as follows: history of spinal surgery, inclusion in physiotherapy program in the last 6 months, pregnancy, risk of osteoporosis and positive test of vertebrobasilar artery. According to these criteria, 81 patients with chronic neck pain and 40 without any pain in their neck (as the control group) were included in the study. Individuals with neck pain were divided into 2 groups according to the severity of their pain. Individuals with neck pain score of 5 or less according to Visual Analogue Scale (VAS) were identified as Group 1, whereas those with any score
Who may be able to join
- 18-65 years old
- presence of neck pain for at least 3 months
- absence of any other problems related to other parts of the spine such as low back pain
- absence of any neurological, rheumatical or musculoskeletal problems
- pregnancy
- risk of osteoporosis
- positive test of vertebrobasilar artery
Who cannot join
- history of spinal surgery
About this study
Official title: Investigation of the Relationship Between Neck Pain and Spinal Curvatures in Patients With Chronic Neck Pain
Although it is known that the cervical, thoracic and lumbar regions of the spine are related with each other biomechanically, there are no studies examining the relationship between cervical pain and other regions of the spine. The purpose of this study was to examine angular changes of the spine and compare it with the control group according to the state of pain in patients with neck pain.
81 patients with chronic neck pain and 40 without any pain in their neck were included in the study. Spinal Mouse device was used to evaluate thoracic and lumbar curvatures. The pain sensory was evaluated with VAS.
Read the detailed description
Neck pain is one of the most common problems among musculoskeletal disorders. Individuals with recurrent neck pain are characterized with chronic and recurrent pain periods, and their activities and quality of life are adversely affected. The causes of neck pain are not fully known. Long-term wrong static posture is considered as one of the most important causes of neck pain..
When studies examining the relationship between neck pain and spinal normality are investigated, it is seen that these studies mainly focus on the relationship between neck pain and cervical posture. In these studies, it is suggested that abnormal cervical lordosis and forward head posture are associated with neck pain development and its recurrence.
Although there are many studies examining the relationship between neck pain and the posture of the cervical region, studies investigating postural and angular changes in other parts of the spine in patients with neck pain are inadequate. In a review study, which stated that each segment of the spine is interrelated to other segments, it was mentioned that pelvis is associated with lumbar lordosis, lumbar lordosis is interrelated to thoracic kyphosis, and thoracic kyphosis has an impact on cervical lordosis. On the other hand, in this review study, it was emphasized that the relationship between pelvis and thoracic region decreases as the path from the pelvis to the cervical region becomes complicated. However, it is reported that when a postural disorder such as a decrease in lumbar lordosis and/or an increase in thoracic kyphosis occurs, the cervical lordosis increases as a compensatory mechanism.
Although it is known that the cervical, thoracic and lumbar regions of the spine are related with each other biomechanically, there are no studies examining the relationship between cervical pain and other regions of the spine. Lau et al. reported that the upper thoracic angle increases in patients with neck pain and this angle is a good predictor of neck pain.
Since the spine is a whole, it is thought that any deficiency at one end of the whole can affect other segments. Therefore, the purpose of this study was to examine angular changes of the spine and compare it with the control group according to the state of pain in patients with chronic neck pain.
- Conditions
- Neck Pain
- Keywords
- spinal curvatures, neck pain
- Medical subject headings
- Neck Pain, Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the Experimental group | Individuals with neck pain score of 5 or less according to Visual Analogue Scale (VAS) were identified as Group 1 | |
| the control group | Individuals with neck pain score of 5 or less according to Visual Analogue Scale (VAS) were identified as Group 1, whereas those with any score above 5 were identified as Group 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
Demographic data (age, height, weight, body mass index (BMI) and duration of symptoms (duration of diagnosis)) of all individuals were recorded. All individuals were evaluated by the same researcher (OB) using the same test protocol.
Measured: baseline
Visual Analog Scale
The severity of pain was evaluated by VAS. The average pain intensity in the last 4 weeks was questioned. The patients were asked to mark the severity of their pain on a 10-centimeter-long line where 0 stands for no pain and 10 for intolerable pain. The results were recorded in centimeter.
Measured: baseline
Thoracic and Lumbar Curvatures
Thoracic and Lumbar Curvatures: Thoracic and lumbar region curvatures of individuals included in the study were evaluated by using Spinal Mouse (SM) (Idiag, Volkerswill, Switzerland). SM is a computer-aided electromechanical device that measures the curvatures of the spine at various postures. The locations marked on the skin were first determined by palpation and then marked with a cosmetic pen on the skin. The SM device was placed onto the 7th cervical vertebra and the recording started by pressing the button. Then the device was moved over the spinous processes of the spine from the 7th cervical vertebrae down to the 3rd sacral vertebrae where the button on the device was pressed again to finish the assessment. At a frequency of about 150 Hz, the device makes measurements along the spine at every 1.3 mm and records the data (The average length of the spine is 550 mm and the time required to measure the entire length is 2 to 4 seconds, so approximately 423 measurements are made in 3
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start10 May 2013
- Primary completion10 Jun 2013
- Study completion11 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket Büyükturan, Kirsehir Ahi Evran Universitesi
- Investigators
- ÖZNUR büyükturan, professor, Study director, Kırşehir Ahi Evran Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884137
- Sponsor's protocol ID
- 28.06.2012/4271/223
- Acronym
- neck pain
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Neck Pain and Spinal Curvatures in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06884137
- Acronym / sponsor ID
- neck pain / 28.06.2012/4271/223
- Conditions
- Neck Pain
- Keywords
- spinal curvatures, neck pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 10 May 2013 (actual)
- Primary completion
- 10 Jun 2013 (actual)
- Study completion
- 11 Jun 2013 (actual)
- First posted
- 19 Mar 2025 (actual)
- 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.
Although it is known that the cervical, thoracic and lumbar regions of the spine are related with each other biomechanically, there are no studies examining the relationship between cervical pain and other regions of the spine. The purpose of this study was to examine angular changes of the spine and compare it with the control group according to the state of pain in patients with neck pain.
81 patients with chronic neck pain and 40 without any pain in their neck were included in the study. Spinal Mouse device was used to evaluate thoracic and lumbar curvatures. The pain sensory was evaluated with VAS.
Detailed description
Neck pain is one of the most common problems among musculoskeletal disorders. Individuals with recurrent neck pain are characterized with chronic and recurrent pain periods, and their activities and quality of life are adversely affected. The causes of neck pain are not fully known. Long-term wrong static posture is considered as one of the most important causes of neck pain..
When studies examining the relationship between neck pain and spinal normality are investigated, it is seen that these studies mainly focus on the relationship between neck pain and cervical posture. In these studies, it is suggested that abnormal cervical lordosis and forward head posture are associated with neck pain development and its recurrence.
Although there are many studies examining the relationship between neck pain and the posture of the cervical region, studies investigating postural and angular changes in other parts of the spine in patients with neck pain are inadequate. In a review study, which stated that each segment of the spine is interrelated to other segments, it was mentioned that pelvis is associated with lumbar lordosis, lumbar lordosis is interrelated to thoracic kyphosis, and thoracic kyphosis has an impact on cervical lordosis. On the other hand, in this review study, it was emphasized that the relationship between pelvis and thoracic region decreases as the path from the pelvis to the cervical region becomes complicated. However, it is reported that when a postural disorder such as a decrease in lumbar lordosis and/or an increase in thoracic kyphosis occurs, the cervical lordosis increases as a compensatory mechanism.
Although it is known that the cervical, thoracic and lumbar regions of the spine are related with each other biomechanically, there are no studies examining the relationship between cervical pain and other regions of the spine. Lau et al. reported that the upper thoracic angle increases in patients with neck pain and this angle is a good predictor of neck pain.
Since the spine is a whole, it is thought that any deficiency at one end of the whole can affect other segments. Therefore, the purpose of this study was to examine angular changes of the spine and compare it with the control group according to the state of pain in patients with chronic neck pain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Experimental group | – | –Individuals with neck pain score of 5 or less according to Visual Analogue Scale (VAS) were identified as Group 1 |
| the control group | – | –Individuals with neck pain score of 5 or less according to Visual Analogue Scale (VAS) were identified as Group 1, whereas those with any score above 5 were identified as Group 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who were referred to the physiotherapy program by a specialist physician (SS) and met the inclusion criteria were included in the study. Inclusion criteria were as follows: being 18-65 years old, presence of neck pain for at least 3 months, absence of any other problems related to other parts of the spine such as low back pain, absence of any neurological, rheumatical or musculoskeletal problems. Exclusion criteria were as follows: history of spinal surgery, inclusion in physiotherapy program in the last 6 months, pregnancy, risk of osteoporosis and positive test of vertebrobasilar artery. According to these criteria, 81 patients with chronic neck pain and 40 without any pain in their neck (as the control group) were included in the study. Individuals with neck pain were divided into 2 groups according to the severity of their pain. Individuals with neck pain score of 5 or less according to Visual Analogue Scale (VAS) were identified as Group 1, whereas those with any score
Key inclusion criteria (7 listed)
- 18-65 years old
- presence of neck pain for at least 3 months
- absence of any other problems related to other parts of the spine such as low back pain
- absence of any neurological, rheumatical or musculoskeletal problems
- pregnancy
Key exclusion criteria (1 listed)
- history of spinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic data
Time frame: baseline
Demographic data (age, height, weight, body mass index (BMI) and duration of symptoms (duration of diagnosis)) of all individuals were recorded. All individuals were evaluated by the same researcher (OB) using the same test protocol.
Visual Analog Scale
Time frame: baseline
The severity of pain was evaluated by VAS. The average pain intensity in the last 4 weeks was questioned. The patients were asked to mark the severity of their pain on a 10-centimeter-long line where 0 stands for no pain and 10 for intolerable pain. The results were recorded in centimeter.
Thoracic and Lumbar Curvatures
Time frame: baseline
Thoracic and Lumbar Curvatures: Thoracic and lumbar region curvatures of individuals included in the study were evaluated by using Spinal Mouse (SM) (Idiag, Volkerswill, Switzerland). SM is a computer-aided electromechanical device that measures the curvatures of the spine at various postures. The locations marked on the skin were first determined by palpation and then marked with a cosmetic pen on the skin. The SM device was placed onto the 7th cervical vertebra and the recording started by pressing the button. Then the device was moved over the spinous processes of the spine from the 7th cervical vertebrae down to the 3rd sacral vertebrae where the button on the device was pressed again to finish the assessment. At a frequency of about 150 Hz, the device makes measurements along the spine at every 1.3 mm and records the data (The average length of the spine is 550 mm and the time required to measure the entire length is 2 to 4 seconds, so approximately 423 measurements are made in 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
ÖZNUR büyükturan, professor study director
Kırşehir Ahi Evran Univercity
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by Kirsehir Ahi Evran Universitesi.
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 7 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: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2025.