NCT05032911

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

August 31, 2021

Last Update Submit

September 2, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • Physical activity level

    1 year

  • Fear of movement and injury

    1 year

  • Pain-related fear-avoidance

    1 year

Study Arms (2)

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

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

Interventions

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

Asymptomatic participantsNeck pain patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Population aged between 18 and 65 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Movement DisordersNeck Pain

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Aitor Martin Pintado Zugasti, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 2, 2021

Study Start

October 10, 2021

Primary Completion

February 15, 2022

Study Completion

February 15, 2023

Last Updated

September 10, 2021

Record last verified: 2021-09