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Neck Motion and Motor Control in Chronic Neck Pain and Associations With Clinical Symptoms

This study is currently recruiting participants.
Verified January 2013 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01778036
First received: January 25, 2013
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

The primary purpose of this study is to investigate if there is altered motor control of head and neck in chronic neck pain patients compared with healthy persons. In addition, associations between neck pain, motor control, disability and function, and clinical symptoms will be studied in patients following physiotherapy treatment in primary health care.


Condition
Neck Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neck Motion and Motor Control in Chronic Neck Pain and Associations With Clinical Symptoms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Conjunct motion [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Describes the movement stiffness in active movements of the neck. Conjunct motion is movement in the two associated movement planes to the primary plane. For example,the amount of rotation and lateral flexion during neck flexion and extension. Measured by 3D Liberty device and with degrees as unit of measure.


Secondary Outcome Measures:
  • head motion smoothness [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Measured by a 3D Liberty device and with velocity(degrees/s)as unit of measure

  • reposition accuracy [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Measured by 3D Liberty device and with degrees as unit of measure

  • postural sway. [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Measured by 3D Liberty device and trunk sway as a unit of measure

  • Head stabilization [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Measured by 3D Liberty device and with velocity (degrees/second) as unit of measure

  • pain [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    a numerical pain rating scale will be used to measure neck pain.

  • Head motion accuracy [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Head motion accuracy will be measured by a 3D Liberty device and centimeter will be used as a unit of measure


Other Outcome Measures:
  • Neck disability and function [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Neck Disability Index and patient specific functional scale(Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale and Pain Self Efficacy Scale)


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neck pain patients following physiotherapy treatment
Neck pain patients will follow physiotherapy treatment in primary health care.

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Neck pain patients referred to physiotherapy treatment in primary health care

Criteria

Inclusion Criteria:

  • Idiopathic neck pain with duration >2 weeks
  • Normal or corrected vision
  • Pain at or above 3 on Numeric Rating Scale, with "low pain" defined as 3-4 and "high pain" as 5 or higher.

Exclusion Criteria:

  • Systemic or diagnosed chronic disease, including diabetes, stroke and neurological diseases, that may influence motor control and neck pain or ability to perform tests
  • positive spurling test for neurological radiating arm pain
  • pregnancy
  • whiplash
  • insufficient comprehension of Norwegian language
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778036

Contacts
Contact: Ingebrigt Meisingset, MSc ingebrigt.meisingset@ntnu.no
Contact: Ottar Vasseljen, Professor ottar.vasseljen@ntnu.no

Locations
Norway
University of Oslo Recruiting
Oslo, Norway
Norwegian University of Science and Technology Recruiting
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
University of Oslo
Investigators
Study Director: Ottar Vasseljen, prof Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01778036     History of Changes
Other Study ID Numbers: 2011/2522
Study First Received: January 25, 2013
Last Updated: January 31, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
Neck movement
motor control
disability
psychological variables
Head Movements
Physical therapy
 Fear avoidance
Self Efficacy
Catastrophizing
Fly test
Postural sway

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013