NCT02789631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

April 22, 2016

Last Update Submit

May 5, 2017

Conditions

Outcome Measures

Primary Outcomes (15)

  • flexor and extensor cervical muscles holding time (second)

    2 years

  • cervical, back, lowback, upper limbs, lower limbs muscles and trunk maximal contraction force against resistance (N)

    2 years

  • head inclination angle, lumbar and thoracic angles in sagittal plane and thoracic angle in the coronal plane (degrees)

    2 years

  • pelvic inclination in the sagittal and coronal planes (degrees)

    2 years

  • cervical, back, low back, upper limbs, lower limbs and trunk range of motion in sagittal and coronal planes (degrees)

    2 years

  • cervical re-positioning error (degrees)

    2 years

  • the result of Dixhallpike test (positive or negative for vertigo and nystagmus)

    2 years

  • neck disability questionnaire score

    2 years

  • distance between T2 spinous process and spine of the scapula (cm)

    2 years

  • the difference between chest circumference at xiphoid process, axillary and umbliqus levels in the inhalation and exhalation phases of respiration (cm)

    2 years

  • the result of the Romberg test (seconds)

    2 years

  • the result of the upper cervical flexion with rotation test (positive/negative)

    2 years

  • the result of the Gaze test (positive/negative)

    2 years

  • pain reproduction test by the algometer at 2.5 kg pressure level (positive/negative)

    2 years

  • visual analogue scale score

    2 years

Secondary Outcomes (26)

  • Pearson correlation coefficient of the cervical muscles holding time with visual analogue scale score

    2 years

  • Pearson correlation coefficient of the cervical muscles holding time with neck disability index questionnaire score

    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

    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

    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

    2 years

  • +21 more secondary outcomes

Study Arms (2)

chronic neck pain

experiencing neck pain for at least 3 months in the last year

Other: assessment

without neck pain (asymptomatic)

no history of neck pain

Other: assessment

Interventions

chronic neck painwithout neck pain (asymptomatic)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

subjects with and without neck pain

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Social Welfare and Rehabilitation Sciences

Tehran, 1985713831, Iran

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neck Pain

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

April 22, 2016

First Posted

June 3, 2016

Study Start

October 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations