Sensorimotor Control in People With and Without Neck Pain

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05032911
• Other study ID #: CEU-023
• Status: Not yet recruiting
• Start date: October 10, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: September 2021
• Source: CEU San Pablo University
• Contact: Aitor Martin Pintado Zugasti, PhD
• Phone: 91 3724700
• Email: martinpintado[@]ceu.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Movement Disorders
• Neck Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CEU San Pablo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active range of motion	Expressed as an angular displacement (°) in 3 full-movements (flexion-extension, lateral flexion and rotation)	1 year
Primary	Movement speed	Expressed as angular velocity (°/sec) in 3 full-movements (flexion-extension, lateral flexion and rotation)	1 year
Primary	Smoothness of motion	expressed as movement jerk (º/sec3)	1 year
Primary	Head repositioning accuracy	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	1 year
Primary	Motion coupling patterns	Calculated as the angular displacement occurring in a different anatomical plane to the one that is being tested for each of the planar movements	1 year
Secondary	Physical activity level	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.	1 year
Secondary	Fear of movement and injury	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.	1 year
Secondary	Pain-related fear-avoidance	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.	1 year