Neck PainNCT03861312
Laterality Discrimination in Patients With Non-specific Chronic Neck Pain
A study testing Neck Laterality and Foot Laterality in people with Neck Pain, run by Centro Universitario La Salle.
Trial summary
Chronic neck pain is one of the most common causes of pain, affecting 15% of the adult population, and the fourth leading cause of disability. The recognition of laterality is the ability to recognize a part of the body that belongs to the left or right which is used as a tool to create a normal process of motor… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Neck Laterality and Foot Laterality
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Sep 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria were as follows: a) men and women aged between 18- and 65-years b) medical diagnosis of Non-Specific Chronic Neck Pain with more than 6 months of evolution of neck pain.
Who cannot join
- Exclusion criteria included the following: a) patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries or history of arthrodesis, b) systemic diseases, c) vision, hearing or vestibular problems, d) Severe trauma or traffic accident which has had an impact on the cervical area.
About this study
Official title: Effects of Laterality Discrimination in Patients With Non-specific Chronic Neck Pain. Randomized Blind Clinical Trial
Chronic neck pain is one of the most common causes of pain, affecting 15% of the adult population, and the fourth leading cause of disability. The recognition of laterality is the ability to recognize a part of the body that belongs to the left or right which is used as a tool to create a normal process of motor planning.
Read the detailed description
The most consistent data come from the investigation of the primary motor cortex, in which the cortical representations of the altered body part are affected when there is chronic pain. Occasionally, the primary motor cortex is smaller on the affected side than on the contralateral side.
Recognition of the body schema is altered in the presence of painful disorders. The most common way of assessing the body schema is by motor imagery through the laterality discrimination of the left and right.
- Conditions
- Neck Pain
- Being tested
- Neck Laterality, Foot Laterality
- Keywords
- Laterality task, neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck LateralityBehavioural
Patients who belonged to the neck group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the "Vanilla" program
Foot LateralityBehavioural
Patients who belonged to the foot group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the "Vanilla" program
| Study group | Role | What they receive |
|---|---|---|
| Neck Laterality | Experimental | It was done with 20 images of necks and 4 seconds for each image in the Vanilla program of the tablet application. Receives: Behavioral: Neck Laterality |
| Foot Laterality | Experimental | It was done with 20 images of feet and 4 seconds for each image in the Vanilla program of the tablet application. Receives: Behavioral: Foot Laterality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response time
Changes in the time response. Time response is defined as the time between the image appearance and the subject response.
Measured: Immediately post-intervention
Accuracy
Changes in the accuracy at the end of the intervention. Accuracy must be taken as the precision of the response when a subject say wether the image is right or left. It is measured by percentage of success.
Measured: Immediately post-intervention
Joint Position Error
Changes in the joint position error at the end of the intervention. It is measured on centimeters.
Measured: Immediately post-intervention
Cervical Active Range of Motion
Changes the cervical active range of motion at the end of the intervention. It is measured on centimeters.
Measured: immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study startDec 2016
- Primary completionMay 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Vicente Leon Hernandez, Centro Universitario La Salle
- Investigators
- David Marcos Lorenzo, Msc, Study chair, d.marcosl20@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861312
- Sponsor's protocol ID
- CSEULS-PI-155/2017
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2019
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laterality Discrimination in Patients With Non-specific Chronic Neck Pain. Randomized Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03861312
- Acronym / sponsor ID
- CSEULS-PI-155/2017
- Conditions
- Neck Pain
- Keywords
- Laterality task, neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Mar 2019 (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.
Chronic neck pain is one of the most common causes of pain, affecting 15% of the adult population, and the fourth leading cause of disability. The recognition of laterality is the ability to recognize a part of the body that belongs to the left or right which is used as a tool to create a normal process of motor planning.
Detailed description
The most consistent data come from the investigation of the primary motor cortex, in which the cortical representations of the altered body part are affected when there is chronic pain. Occasionally, the primary motor cortex is smaller on the affected side than on the contralateral side.
Recognition of the body schema is altered in the presence of painful disorders. The most common way of assessing the body schema is by motor imagery through the laterality discrimination of the left and right.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck Laterality | Experimental | Behavioral: Neck LateralityIt was done with 20 images of necks and 4 seconds for each image in the Vanilla program of the tablet application. |
| Foot Laterality | Experimental | Behavioral: Foot LateralityIt was done with 20 images of feet and 4 seconds for each image in the Vanilla program of the tablet application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria were as follows: a) men and women aged between 18- and 65-years b) medical diagnosis of Non-Specific Chronic Neck Pain with more than 6 months of evolution of neck pain.
Key exclusion criteria (1 listed)
- Exclusion criteria included the following: a) patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries or history of arthrodesis, b) systemic diseases, c) vision, hearing or vestibular problems, d) Severe trauma or traffic accident which has had an impact on the cervical area.
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 |
|---|---|---|
| Neck LateralityPatients who belonged to the neck group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the "Vanilla" program | Behavioural | Neck Laterality |
| Foot LateralityPatients who belonged to the foot group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the "Vanilla" program | Behavioural | Foot Laterality |
Primary outcome
Response time
Time frame: Immediately post-intervention
Changes in the time response. Time response is defined as the time between the image appearance and the subject response.
Accuracy
Time frame: Immediately post-intervention
Changes in the accuracy at the end of the intervention. Accuracy must be taken as the precision of the response when a subject say wether the image is right or left. It is measured by percentage of success.
Joint Position Error
Time frame: Immediately post-intervention
Changes in the joint position error at the end of the intervention. It is measured on centimeters.
Cervical Active Range of Motion
Time frame: immediately post-intervention
Changes the cervical active range of motion at the end of the intervention. It is measured on centimeters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
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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.
David Marcos Lorenzo, Msc study chair
d.marcosl20@gmail.com
Questions about this trial
What is this clinical trial studying?
A study testing Neck Laterality and Foot Laterality in people with Neck Pain, run by Centro Universitario La Salle.
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 1 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: finished, as of the sponsor's last update on 4 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response time (time frame: Immediately post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2019.