NCT01778036

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

2 active sites

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

January 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

January 25, 2013

Last Update Submit

March 23, 2017

Conditions

Keywords

Neck movementmotor controldisabilitypsychological variablesHead MovementsPhysical therapyFear avoidanceSelf EfficacyCatastrophizingFly testPostural sway

Outcome Measures

Primary Outcomes (1)

  • Conjunct motion

    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.

    up to 8 weeks

Secondary Outcomes (6)

  • head motion smoothness

    up to 8 weeks

  • reposition accuracy

    up to 8 weeks

  • postural sway.

    up to 8 weeks

  • Head stabilization

    up to 8 weeks

  • pain

    up to 24 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • Neck disability and function

    up to 24 weeks

Study Arms (1)

Neck pain patients following physiotherapy treatment

Neck pain patients will follow physiotherapy treatment in primary health care.

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Neck pain patients referred to physiotherapy treatment in primary health care

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Oslo

Oslo, Norway

Location

Norwegian University of Science and Technology

Trondheim, Norway

Location

Related Publications (1)

  • Meisingset I, Stensdotter AK, Woodhouse A, Vasseljen O. Neck motion, motor control, pain and disability: A longitudinal study of associations in neck pain patients in physiotherapy treatment. Man Ther. 2016 Apr;22:94-100. doi: 10.1016/j.math.2015.10.013. Epub 2015 Nov 2.

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ottar Vasseljen, prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations