Neck PainNCT02789631
Relationship Between Musculoskeletal, Sensorimotor and Functional Factors and Nonspecific Chronic Neck Pain
An observational study of Neck Pain, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
Trial summary
Several factors have been associated with neck pain. Controversy exists regarding the degree of association between some of these factors and neck pain. Information regarding the degree of association of each factor to neck pain is needed for effective prevention and appropriate treatment strategies. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- assessment
- How many people
- 232 participants
- Where
- 1 siteIran
- Study dates
- Oct 2015to Apr 2017
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: subjects with and without neck pain
Who may be able to join
- for subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale.
- for healthy subjects: no history of neck pain
Who cannot join
- history of cervical discopathy
- any surgery on neck
- traumatic neck injury
- any congenital disorders
Trial locations and contacts
1 site in 1 country.
Iran1 site
University of Social Welfare and Rehabilitation Sciences
Tehran, 1985713831
About this study
Several factors have been associated with neck pain. Controversy exists regarding the degree of association between some of these factors and neck pain. Information regarding the degree of association of each factor to neck pain is needed for effective prevention and appropriate treatment strategies. The aim of this study is to investigate the association among musculoskeletal, sensorimotor factors and functional disability and occurrence of chronic nonspecific neck pain.
- Conditions
- Neck Pain
- Being tested
- assessment
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| chronic neck pain | experiencing neck pain for at least 3 months in the last year Receives: Other: assessment | |
| without neck pain (asymptomatic) | no history of neck pain Receives: Other: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
flexor and extensor cervical muscles holding time (second)
Measured: 2 years
cervical, back, lowback, upper limbs, lower limbs muscles and trunk maximal contraction force against resistance (N)
Measured: 2 years
head inclination angle, lumbar and thoracic angles in sagittal plane and thoracic angle in the coronal plane (degrees)
Measured: 2 years
pelvic inclination in the sagittal and coronal planes (degrees)
Measured: 2 years
cervical, back, low back, upper limbs, lower limbs and trunk range of motion in sagittal and coronal planes (degrees)
Measured: 2 years
cervical re-positioning error (degrees)
Measured: 2 years
the result of Dixhallpike test (positive or negative for vertigo and nystagmus)
Measured: 2 years
neck disability questionnaire score
Measured: 2 years
distance between T2 spinous process and spine of the scapula (cm)
Measured: 2 years
the difference between chest circumference at xiphoid process, axillary and umbliqus levels in the inhalation and exhalation phases of respiration (cm)
Measured: 2 years
the result of the Romberg test (seconds)
Measured: 2 years
the result of the upper cervical flexion with rotation test (positive/negative)
Measured: 2 years
the result of the Gaze test (positive/negative)
Measured: 2 years
pain reproduction test by the algometer at 2.5 kg pressure level (positive/negative)
Measured: 2 years
visual analogue scale score
Measured: 2 years
Secondary outcomes (26)
Pearson correlation coefficient of the cervical muscles holding time with visual analogue scale score
Measured: 2 years
Pearson correlation coefficient of the cervical muscles holding time with neck disability index questionnaire score
Measured: 2 years
Pearson correlation coefficient of cervical, back, lowback, upper limbs, lower limbs muscles and trunk maximal contraction force against resistance with neck disability index questionnaire score
Measured: 2 years
Pearson correlation coefficient of cervical, back, lowback, upper limbs, lower limbs muscles and trunk maximal contraction force against resistance with visual analogue scale score
Measured: 2 years
Pearson correlation coefficient of head inclination angle, lumbar and thoracic angles in sagittal plane and thoracic angle in the coronal plane with visual analogue scale score
Measured: 2 years
Pearson correlation coefficient of head inclination angle, lumbar and thoracic angles in sagittal plane and thoracic angle in the coronal plane with neck disability index score
Measured: 2 years
Pearson correlation coefficient of pelvic inclination in the sagittal and coronal planes with neck disability index score
Measured: 2 years
Pearson correlation coefficient of pelvic inclination in the sagittal and coronal planes with visual analogue scale score
Measured: 2 years
Pearson correlation coefficient of cervical, back, low back, upper limbs, lower limbs and trunk range of motion in sagittal and coronal planes with neck disability index score
Measured: 2 years
Pearson correlation coefficient of cervical, back, low back, upper limbs, lower limbs and trunk range of motion in sagittal and coronal planes with visual analogue scale score
Measured: 2 years
Pearson correlation coefficient of the difference between chest circumference at xiphoid process, axillary and umbliqus levels in the inhalation and exhalation phases of respiration with visual analogue scale score
Measured: 2 years
Pearson correlation coefficient of the difference between chest circumference at xiphoid process, axillary and umbliqus levels in the inhalation and exhalation phases of respiration with neck disability index score
Measured: 2 years
Pearson correlation coefficient of distance between T2 spinous process and spine of the scapula with neck disability index score
Measured: 2 years
Pearson correlation coefficient of distance between T2 spinous process and spine of the scapula with visual analogue scale score
Measured: 2 years
Pearson correlation coefficient of cervical re-positioning error with visual analogue scale score
Measured: 2 years
Pearson correlation coefficient of cervical re-positioning error with neck disability index score
Measured: 2 years
Pearson correlation coefficient of Romberg test with neck disability index score
Measured: 2 years
Pearson correlation coefficient of Romberg test with visual analogue scale score
Measured: 2 years
Spearman correlation coefficient of pain reproduction test by the algometer at 2.5 kg pressure level with visual analogue scale score
Measured: 2 years
Spearman correlation coefficient of pain reproduction test by the algometer at 2.5 kg pressure level with neck disability index score
Measured: 2 years
Spearman correlation coefficient of the result of the upper cervical flexion with rotation test with neck disability index score
Measured: 2 years
Spearman correlation coefficient of the result of the upper cervical flexion with rotation test with visual analogue scale score
Measured: 2 years
Spearman correlation coefficient of the result of Dixhallpike test with visual analogue scale score
Measured: 2 years
Spearman correlation coefficient of the result of Dixhallpike test with neck disability index score
Measured: 2 years
Spearman correlation coefficient of the result of Gaze test with neck disability index score
Measured: 2 years
Spearman correlation coefficient of the result of Gaze test with visual analogue scale score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Time perspective
- Cross-sectional
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. L. Ghamkhar, University of Social Welfare and Rehabilitation Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789631
- Sponsor's protocol ID
- IR.USWR.REC.1394.224
- Status last verified
- May 2017
- First submitted
- 22 Apr 2016
- Last updated
- 8 May 2017
- Results posted
- No
Publications
Kahlaee AH, Ghamkhar L, Nourbakhsh MR, Arab AM. Strength and Range of Motion in the Contralateral Side to Pain and Pain-Free Regions in Unilateral Chronic Nonspecific Neck Pain Patients. Am J Phys Med Rehabil. 2020 Feb;99(2):133-141. doi: 10.1097/PHM.0000000000001298.
PubMed 31464752
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Musculoskeletal, Sensorimotor and Functional Factors and Nonspecific Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT02789631
- Acronym / sponsor ID
- IR.USWR.REC.1394.224
- Conditions
- Neck Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 Jun 2016 (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.
Several factors have been associated with neck pain. Controversy exists regarding the degree of association between some of these factors and neck pain. Information regarding the degree of association of each factor to neck pain is needed for effective prevention and appropriate treatment strategies. The aim of this study is to investigate the association among musculoskeletal, sensorimotor factors and functional disability and occurrence of chronic nonspecific neck pain.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic neck pain | – | Other: assessmentexperiencing neck pain for at least 3 months in the last year |
| without neck pain (asymptomatic) | – | Other: assessmentno history of neck pain |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- subjects with and without neck pain
Key inclusion criteria (2 listed)
- for subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale.
- for healthy subjects: no history of neck pain
Key exclusion criteria (4 listed)
- history of cervical discopathy
- any surgery on neck
- traumatic neck injury
- any congenital disorders
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 |
|---|---|---|
| assessment | Other | chronic neck pain, without neck pain (asymptomatic) |
Primary outcome
flexor and extensor cervical muscles holding time (second)
Time frame: 2 years
cervical, back, lowback, upper limbs, lower limbs muscles and trunk maximal contraction force against resistance (N)
Time frame: 2 years
head inclination angle, lumbar and thoracic angles in sagittal plane and thoracic angle in the coronal plane (degrees)
Time frame: 2 years
pelvic inclination in the sagittal and coronal planes (degrees)
Time frame: 2 years
cervical, back, low back, upper limbs, lower limbs and trunk range of motion in sagittal and coronal planes (degrees)
Time frame: 2 years
cervical re-positioning error (degrees)
Time frame: 2 years
the result of Dixhallpike test (positive or negative for vertigo and nystagmus)
Time frame: 2 years
neck disability questionnaire score
Time frame: 2 years
distance between T2 spinous process and spine of the scapula (cm)
Time frame: 2 years
the difference between chest circumference at xiphoid process, axillary and umbliqus levels in the inhalation and exhalation phases of respiration (cm)
Time frame: 2 years
the result of the Romberg test (seconds)
Time frame: 2 years
the result of the upper cervical flexion with rotation test (positive/negative)
Time frame: 2 years
the result of the Gaze test (positive/negative)
Time frame: 2 years
pain reproduction test by the algometer at 2.5 kg pressure level (positive/negative)
Time frame: 2 years
visual analogue scale score
Time frame: 2 years
26 secondary outcomes
Pearson correlation coefficient of the cervical muscles holding time with visual analogue scale score
Time frame: 2 years
Pearson correlation coefficient of the cervical muscles holding time with neck disability index questionnaire score
Time frame: 2 years
Pearson correlation coefficient of cervical, back, lowback, upper limbs, lower limbs muscles and trunk maximal contraction force against resistance with neck disability index questionnaire score
Time frame: 2 years
Pearson correlation coefficient of cervical, back, lowback, upper limbs, lower limbs muscles and trunk maximal contraction force against resistance with visual analogue scale score
Time frame: 2 years
Pearson correlation coefficient of head inclination angle, lumbar and thoracic angles in sagittal plane and thoracic angle in the coronal plane with visual analogue scale score
Time frame: 2 years
Pearson correlation coefficient of head inclination angle, lumbar and thoracic angles in sagittal plane and thoracic angle in the coronal plane with neck disability index score
Time frame: 2 years
Pearson correlation coefficient of pelvic inclination in the sagittal and coronal planes with neck disability index score
Time frame: 2 years
Pearson correlation coefficient of pelvic inclination in the sagittal and coronal planes with visual analogue scale score
Time frame: 2 years
Pearson correlation coefficient of cervical, back, low back, upper limbs, lower limbs and trunk range of motion in sagittal and coronal planes with neck disability index score
Time frame: 2 years
Pearson correlation coefficient of cervical, back, low back, upper limbs, lower limbs and trunk range of motion in sagittal and coronal planes with visual analogue scale score
Time frame: 2 years
Pearson correlation coefficient of the difference between chest circumference at xiphoid process, axillary and umbliqus levels in the inhalation and exhalation phases of respiration with visual analogue scale score
Time frame: 2 years
Pearson correlation coefficient of the difference between chest circumference at xiphoid process, axillary and umbliqus levels in the inhalation and exhalation phases of respiration with neck disability index score
Time frame: 2 years
Pearson correlation coefficient of distance between T2 spinous process and spine of the scapula with neck disability index score
Time frame: 2 years
Pearson correlation coefficient of distance between T2 spinous process and spine of the scapula with visual analogue scale score
Time frame: 2 years
Pearson correlation coefficient of cervical re-positioning error with visual analogue scale score
Time frame: 2 years
Pearson correlation coefficient of cervical re-positioning error with neck disability index score
Time frame: 2 years
Pearson correlation coefficient of Romberg test with neck disability index score
Time frame: 2 years
Pearson correlation coefficient of Romberg test with visual analogue scale score
Time frame: 2 years
Spearman correlation coefficient of pain reproduction test by the algometer at 2.5 kg pressure level with visual analogue scale score
Time frame: 2 years
Spearman correlation coefficient of pain reproduction test by the algometer at 2.5 kg pressure level with neck disability index score
Time frame: 2 years
Spearman correlation coefficient of the result of the upper cervical flexion with rotation test with neck disability index score
Time frame: 2 years
Spearman correlation coefficient of the result of the upper cervical flexion with rotation test with visual analogue scale score
Time frame: 2 years
Spearman correlation coefficient of the result of Dixhallpike test with visual analogue scale score
Time frame: 2 years
Spearman correlation coefficient of the result of Dixhallpike test with neck disability index score
Time frame: 2 years
Spearman correlation coefficient of the result of Gaze test with neck disability index score
Time frame: 2 years
Spearman correlation coefficient of the result of Gaze test with visual analogue scale score
Time frame: 2 years
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 8 May 2017.
- Derived from this study: PubMed 31464752Kahlaee AH, Ghamkhar L, Nourbakhsh MR, Arab AM. Strength and Range of Motion in the Contralateral Side to Pain and Pain-Free Regions in Unilateral Chronic Nonspecific Neck Pain Patients. Am J Phys Med Rehabil. 2020 Feb;99(2):133-141. doi: 10.1097/PHM.0000000000001298.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Social Welfare and Rehabilitation Science at 1 site in Iran.
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 4 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 8 May 2017. 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 Iran. 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?
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?
flexor and extensor cervical muscles holding time (second) (time frame: 2 years). The study lists 15 primary outcomes in all. 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 NCT02789631, which also lists 1 linked publication.
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 8 May 2017.