Sensorimotor Control in People With and Without Neck Pain

Analysis of Sensorimotor Control in People With and Without Neck Pain Using Inertial Sensor Technology: Study Protocol for a Longitudinal Prospective Observational Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Movement Disorders; Neck Pain
• Intervention / Treatment: Diagnostic test: sensorimotor control analysis using inertial sensor technology

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Aitor Martin Pintado Zugasti, PhD; Phone Number: 14691 91 3724700; Email: martinpintado@ceu.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from a community sample in Madrid, Spain

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active range of motion	Expressed as an angular displacement (°) in 3 full-movements (flexion-extension, lateral flexion and rotation)	1 year
Movement speed	Expressed as angular velocity (°/sec) in 3 full-movements (flexion-extension, lateral flexion and rotation)	1 year
Smoothness of motion	expressed as movement jerk (º/sec3)	1 year
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: CEU San Pablo University

Publications and helpful links

General Publications

• Moggioli F, Perez-Fernandez T, Liebana S, Corredor EB, Armijo-Olivo S, Fernandez-Carnero J, Raya R, Conde P, Rodriguez-Lopez O, Sanchez C, Martin-Pintado-Zugasti A. Analysis of sensorimotor control in people with and without neck pain using inertial sensor technology: study protocol for a 1-year longitudinal prospective observational study. BMJ Open. 2022 Feb 15;12(2):e058190. doi: 10.1136/bmjopen-2021-058190.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 10, 2021
• Primary Completion (Anticipated): February 15, 2022
• Study Completion (Anticipated): February 15, 2023

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neck Pain; Movement Disorders
• Other Study ID Numbers: CEU-023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No