Sensorimotor Control in People With and Without Neck Pain

Sponsor
CEU San Pablo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05032911
Collaborator
(none)
100
16.2

Study Details

Study Description

Brief Summary

This is a descriptive, observational, longitudinal, prospective study consecutively enrolling patients with non-specific neck pain and age-matched asymptomatic participants.

The investigators will register sensorimotor control variables, including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns. These variables will be recorded by means of Inertial Measurement Unit (IMU) sensors during the following tests consecutively performed in two measuring sessions separated by 12 months: (a) kinematics of planar movements, (b) kinematics of the craniocervical flexion movement, (c) kinematics during functional tasks and (d) kinematics of task-oriented neck movements in response to visual targets.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: sensorimotor control analysis using inertial sensor technology

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Analysis of Sensorimotor Control in People With and Without Neck Pain Using Inertial Sensor Technology: Study Protocol for a Longitudinal Prospective Observational Study
Anticipated Study Start Date :
Oct 10, 2021
Anticipated Primary Completion Date :
Feb 15, 2022
Anticipated Study Completion Date :
Feb 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Asymptomatic participants

Asymptomatic subjects should not present any pain in the cervical region during the last 3 months and no previous treatment for neck pain in order to be included in the study.

Diagnostic Test: sensorimotor control analysis using inertial sensor technology
Inertial Measurement Unit (IMU) sensors will measure sensorimotor control variables including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns

Neck pain patients

Patients with neck pain should have an intensity of pain of at least 3 points out of 10 on a Visual Analog Scale and a neck pain duration of at least 3 months of evolution. Neck pain could be from nonspecific mechanical origin, associated with whiplash or with a previous medical diagnosis of degenerative or inflammatory alterations of the cervical spine, associated or not with headache and pain in the shoulder region or the upper limb.

Diagnostic Test: sensorimotor control analysis using inertial sensor technology
Inertial Measurement Unit (IMU) sensors will measure sensorimotor control variables including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns

Outcome Measures

Primary Outcome Measures

  1. Active range of motion [1 year]

    Expressed as an angular displacement (°) in 3 full-movements (flexion-extension, lateral flexion and rotation)

  2. Movement speed [1 year]

    Expressed as angular velocity (°/sec) in 3 full-movements (flexion-extension, lateral flexion and rotation)

  3. Smoothness of motion [1 year]

    expressed as movement jerk (º/sec3)

  4. Head repositioning accuracy [1 year]

    Calculated as the repositioning error considering the difference between the neutral starting position and the following positions reached after the performance of any of the movements

  5. Motion coupling patterns [1 year]

    Calculated as the angular displacement occurring in a different anatomical plane to the one that is being tested for each of the planar movements

Secondary Outcome Measures

  1. Physical activity level [1 year]

    Measured using the short version of the International Physical Activity Questionnaire (IPAQ). The score of the scale is expressed in MET level x minutes of activity/day x days per week. Levels of 3.3 METs are considered light, 4.0 METs are moderate and 8.0 METs are vigorous.

  2. Fear of movement and injury [1 year]

    Measured using the Tampa Scale for Kinesiophobia (TSK-11). It consists of 11 questions scored from 1 to 4. Therefore, a score of 11 is the lowest possible level of kinesiphobia, while 44 is the highest.

  3. Pain-related fear-avoidance [1 year]

    Measured using the Fear Avoidance Components Scale (FACS). It has 20 itemsmeasured on a 6-point Likert scale for total possible score of 100 and the lowest possible score of 0. Higher scores indicate higher levels of fear avoidance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Population aged between 18 and 65 years old
Exclusion Criteria:
  • Visual impairment not corrected by the use of glasses/contact lenses

  • Migraine headache

  • Complex regional syndrome

  • Previous surgeries in the neck and/or head region

  • Sensory and/or vestibular alterations, (f) Otogenic or idiopathic vertigo/dizziness

  • Presence of tumors in the craniocervical region

  • Previous fracture in the head or neck region

  • Osseous deformities in the thoracic, cervical or cranial region

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • CEU San Pablo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CEU San Pablo University
ClinicalTrials.gov Identifier:
NCT05032911
Other Study ID Numbers:
  • CEU-023
First Posted:
Sep 2, 2021
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2021