Movement DisordersNCT05032911
Sensorimotor Control in People With and Without Neck Pain
An observational study of Movement Disorders and Neck Pain, run by CEU San Pablo University.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders, Neck Pain
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2021to 15 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from a community sample in Madrid, Spain
Who may be able to join
- Population aged between 18 and 65 years old
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Movement Disorders, Neck Pain
- Being tested
- sensorimotor control analysis using inertial sensor technology
- Medical subject headings
- Movement Disorders, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensorimotor control analysis using inertial sensor technologyDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: sensorimotor control analysis using inertial sensor technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active range of motion
Expressed as an angular displacement (°) in 3 full-movements (flexion-extension, lateral flexion and rotation)
Measured: 1 year
Movement speed
Expressed as angular velocity (°/sec) in 3 full-movements (flexion-extension, lateral flexion and rotation)
Measured: 1 year
Smoothness of motion
expressed as movement jerk (º/sec3)
Measured: 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
Measured: 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
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start10 Oct 2021 (estimated)
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032911
- Sponsor's protocol ID
- CEU-023
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35168985
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05032911
- Acronym / sponsor ID
- CEU-023
- Conditions
- Movement Disorders, Neck Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (estimated)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic participants | – | Diagnostic Test: sensorimotor control analysis using inertial sensor technologyAsymptomatic 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. |
| Neck pain patients | – | Diagnostic Test: sensorimotor control analysis using inertial sensor technologyPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from a community sample in Madrid, Spain
Key inclusion criteria (1 listed)
- Population aged between 18 and 65 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensorimotor control analysis using inertial sensor technologyInertial 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 | Diagnostic test | Asymptomatic participants, Neck pain patients |
Primary outcome
Active range of motion
Time frame: 1 year
Expressed as an angular displacement (°) in 3 full-movements (flexion-extension, lateral flexion and rotation)
Movement speed
Time frame: 1 year
Expressed as angular velocity (°/sec) in 3 full-movements (flexion-extension, lateral flexion and rotation)
Smoothness of motion
Time frame: 1 year
expressed as movement jerk (º/sec3)
Head repositioning accuracy
Time frame: 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
Motion coupling patterns
Time frame: 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
3 secondary outcomes
Physical activity level
Time frame: 1 year
Fear of movement and injury
Time frame: 1 year
Pain-related fear-avoidance
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Derived from this study: PubMed 35168985Moggioli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders and Neck Pain, run by CEU San Pablo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aitor Martin Pintado Zugasti, PhD (91 3724700 ext. 14691, martinpintado@ceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active range of motion (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.