Clinical trial NCT02789631: Relationship Between Musculoskeletal, Sensorimotor and Functional Factors and Nonspecific Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Lead sponsor: University of Social Welfare and Rehabilitation Science
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 232
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with and without neck pain

Brief 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. The aim of this study is to investigate the association among musculoskeletal, sensorimotor factors and functional disability and occurrence of chronic nonspecific neck pain.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* history of cervical discopathy
* any surgery on neck
* traumatic neck injury
* any congenital disorders

Primary outcomes:
measure: flexor and extensor cervical muscles holding time (second)
timeFrame: 2 years
measure: cervical, back, lowback, upper limbs, lower limbs muscles and trunk maximal contraction force against resistance (N)
timeFrame: 2 years
measure: head inclination angle, lumbar and thoracic angles in sagittal plane and thoracic angle in the coronal plane (degrees)
timeFrame: 2 years
measure: pelvic inclination in the sagittal and coronal planes (degrees)
timeFrame: 2 years
measure: cervical, back, low back, upper limbs, lower limbs and trunk range of motion in sagittal and coronal planes (degrees)
timeFrame: 2 years
measure: cervical re-positioning error (degrees)
timeFrame: 2 years
measure: the result of Dixhallpike test (positive or negative for vertigo and nystagmus)
timeFrame: 2 years
measure: neck disability questionnaire score
timeFrame: 2 years
measure: distance between T2 spinous process and spine of the scapula (cm)
timeFrame: 2 years
measure: the difference between chest circumference at xiphoid process, axillary and umbliqus levels in the inhalation and exhalation phases of respiration (cm)
timeFrame: 2 years
measure: the result of the Romberg test (seconds)
timeFrame: 2 years
measure: the result of the upper cervical flexion with rotation test (positive/negative)
timeFrame: 2 years
measure: the result of the Gaze test (positive/negative)
timeFrame: 2 years
measure: pain reproduction test by the algometer at 2.5 kg pressure level (positive/negative)
timeFrame: 2 years
measure: visual analogue scale score
timeFrame: 2 years
Secondary outcomes:
measure: Pearson correlation coefficient of the cervical muscles holding time with visual analogue scale score
timeFrame: 2 years
measure: Pearson correlation coefficient of the cervical muscles holding time with neck disability index questionnaire score
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: Pearson correlation coefficient of cervical, back, lowback, upper limbs, lower limbs muscles and trunk maximal contraction force against resistance with visual analogue scale score
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: Pearson correlation coefficient of pelvic inclination in the sagittal and coronal planes with neck disability index score
timeFrame: 2 years
measure: Pearson correlation coefficient of pelvic inclination in the sagittal and coronal planes with visual analogue scale score
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: Pearson correlation coefficient of distance between T2 spinous process and spine of the scapula with neck disability index score
timeFrame: 2 years
measure: Pearson correlation coefficient of distance between T2 spinous process and spine of the scapula with visual analogue scale score
timeFrame: 2 years
measure: Pearson correlation coefficient of cervical re-positioning error with visual analogue scale score
timeFrame: 2 years
measure: Pearson correlation coefficient of cervical re-positioning error with neck disability index score
timeFrame: 2 years
measure: Pearson correlation coefficient of Romberg test with neck disability index score
timeFrame: 2 years
measure: Pearson correlation coefficient of Romberg test with visual analogue scale score
timeFrame: 2 years
measure: Spearman correlation coefficient of pain reproduction test by the algometer at 2.5 kg pressure level with visual analogue scale score
timeFrame: 2 years
measure: Spearman correlation coefficient of pain reproduction test by the algometer at 2.5 kg pressure level with neck disability index score
timeFrame: 2 years
measure: Spearman correlation coefficient of the result of the upper cervical flexion with rotation test with neck disability index score
timeFrame: 2 years
measure: Spearman correlation coefficient of the result of the upper cervical flexion with rotation test with visual analogue scale score
timeFrame: 2 years
measure: Spearman correlation coefficient of the result of Dixhallpike test with visual analogue scale score
timeFrame: 2 years
measure: Spearman correlation coefficient of the result of Dixhallpike test with neck disability index score
timeFrame: 2 years
measure: Spearman correlation coefficient of the result of Gaze test with neck disability index score
timeFrame: 2 years
measure: Spearman correlation coefficient of the result of Gaze test with visual analogue scale score
timeFrame: 2 years
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: University of Social Welfare and Rehabilitation Sciences
Study officials:
References:
citation: 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.